<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771456</url>
  </required_header>
  <id_info>
    <org_study_id>2.0</org_study_id>
    <nct_id>NCT03771456</nct_id>
  </id_info>
  <brief_title>Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery</brief_title>
  <acronym>iCral2</acronym>
  <official_title>Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale C &amp; G Mazzoni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale C &amp; G Mazzoni</source>
  <brief_summary>
    <textblock>
      Prospective observational multicenter study on the influence of adherence to enhanced&#xD;
      recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission,&#xD;
      reoperation rates and length of postoperative stay) after elective colorectal surgery in&#xD;
      Italy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The&#xD;
      overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when&#xD;
      performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses&#xD;
      (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks&#xD;
      usually become apparent between five and seven days postoperatively. Almost half of all leaks&#xD;
      occur after the patient has been discharged, and up to 12 percent occur after postoperative&#xD;
      day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and&#xD;
      nonspecific symptoms attributable to other postoperative infectious complications. Small,&#xD;
      contained leaks present later in the clinical course and may be difficult to distinguish from&#xD;
      postoperative abscesses by radiologic imaging, making the diagnosis uncertain and&#xD;
      underreported.&#xD;
&#xD;
      There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97&#xD;
      studies, as an example, 56 different definitions of an anastomotic leak were used. The&#xD;
      majority of reports define an anastomotic leak using clinical signs, radiographic findings,&#xD;
      and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia,&#xD;
      Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid&#xD;
      collections, Gas containing collections. The intraoperative findings include: Gross enteric&#xD;
      spillage, Anastomotic disruption.&#xD;
&#xD;
      Risk factors for a dehiscence and leak are classified according to the site of the&#xD;
      anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients&#xD;
      undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a&#xD;
      significantly increased risk of anastomotic leak with extraperitoneal compared with&#xD;
      intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).&#xD;
&#xD;
      Major risk factors for an extraperitoneal AL include: The distance of the anastomosis from&#xD;
      the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from&#xD;
      the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia,&#xD;
      Male gender, Obesity.&#xD;
&#xD;
      Major risk factors for an intraperitoneal AL include: American Society of Anesthesiologists&#xD;
      (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic&#xD;
      anastomosis.&#xD;
&#xD;
      Controversial, inconclusive, or pertinent negative associations between the following&#xD;
      variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma,&#xD;
      Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation,&#xD;
      Nutritional status, Perioperative corticosteroids.&#xD;
&#xD;
      Enhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively&#xD;
      studied during the last 20 years. It is now clear that they offer a consistent reduction of&#xD;
      overall morbidity rates, postoperative length of stay and costs, and that there is a clear&#xD;
      dose-effect relation between adherence to at least 60-70% of the program items and these&#xD;
      outcomes. On the other hand, little is known concerning the potential benefit of ERAS&#xD;
      programs over AL rates or if adherence to specific items of the program may reduce AL rates.&#xD;
&#xD;
      Therefore, the investigators planned this study to prospectively evaluate AL rates after&#xD;
      colorectal resections and their interaction with known risk factors and ERAS program items.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Prospective enrollment from January to December 2019 in 41 Italian surgical centers. All&#xD;
      patients undergoing elective colorectal surgery with anastomosis will be included in a&#xD;
      prospective database after having provided a written informed consent. A total of 1,750&#xD;
      patients is expected based on a mean of 43 cases/year per center.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
        1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional&#xD;
           status, diabetes, cardiovascular disease, chronic liver disease, renal failure,&#xD;
           inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)&#xD;
&#xD;
        2. Operative parameters (approach, procedure, anastomotic technique, length of operation,&#xD;
           disease stage)&#xD;
&#xD;
        3. ERAS program items (prehabilitation, counseling, nutritional evaluation,&#xD;
           immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel&#xD;
           preparation, preoperative carbohydrates load, standardized anesthesia protocol,&#xD;
           restrictive i.v. fluid administration, control of body temperature, nausea and vomit&#xD;
           prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of&#xD;
           surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of&#xD;
           anesthesia, early removal of urinary catheter, early mobilization, early oral intake of&#xD;
           fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional&#xD;
           supplements, prepare for early discharge, audit).&#xD;
&#xD;
      Endpoints&#xD;
&#xD;
        1. Anastomotic leakage rate&#xD;
&#xD;
        2. Minor and major complications&#xD;
&#xD;
        3. Length of postoperative hospital stay&#xD;
&#xD;
        4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific&#xD;
           and intraoperative risk factors will be recorded: gender, body mass index, nutritional&#xD;
           status according to the Mini Nutritional Assessment short-form, surgical indication&#xD;
           (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative&#xD;
           albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory&#xD;
           disease, American Society of Anesthesia class, bowel preparation (decision made by&#xD;
           operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique&#xD;
           (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of&#xD;
           drainage, and perioperative blood transfusion(s). During the postoperative period,&#xD;
           patients will be examined by the attending surgeon daily. Fever (central temperature &gt;&#xD;
           38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if&#xD;
           present) will be recorded daily. The attending surgeon will make any decision for&#xD;
           complementary exams and imaging according to his own criteria. The rate of any&#xD;
           complication will be calculated and graded including all leaks (independently of&#xD;
           clinical significance), wound infection (according to the definitions of the Centers for&#xD;
           Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and&#xD;
           physical and radiological examinations), central line infection (positive blood&#xD;
           culture), urinary tract infection (positive urine culture with bacterial count ).&#xD;
           Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from&#xD;
           the hospital.&#xD;
&#xD;
      Main endpoint is anastomotic dehiscence (intended as any deviation from the planned&#xD;
      postoperative course related to the anastomosis, or presence of pus or enteric contents&#xD;
      within the drains, presence of abdominal or pelvic collection in the area of the anastomosis&#xD;
      on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of&#xD;
      contrast through the anastomosis during enema or evident anastomotic dehiscence at&#xD;
      reoperation for postoperative peritonitis). Thus, all detected leaks will be considered&#xD;
      independently of clinical significance. No imaging will be performed routinely in order to&#xD;
      search for leakage.&#xD;
&#xD;
      Secondary endpoints are morbidity and mortality rates, postoperative length of stay,&#xD;
      readmission and reoperation rates.&#xD;
&#xD;
      After anonymization, all data of each single case will be prospectively uploaded by every&#xD;
      local investigator on a protected web-based database. Thereafter, all data will be&#xD;
      incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy,&#xD;
      that will be addressed and solved through strict cooperation between chief investigator, data&#xD;
      manager and participating center.&#xD;
&#xD;
      Statistical Analysis Quantitative values will be expressed as mean ± standard deviation,&#xD;
      median and range; categorical data with percentage frequencies. Mean values of duration of&#xD;
      stay will be compared according to the presence or absence of fistulas using Student's&#xD;
      two-sided t test (allowing for heterogeneity of variances) or with a non-parametric&#xD;
      Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to&#xD;
      assess risk factors for leakage and overall complications. The odds ratio (OR) will be&#xD;
      presented followed by its 95% confidence interval (95% CI). For all statistical tests the&#xD;
      significant level is fixed at p &lt; .05.&#xD;
&#xD;
      Statistical analyses will be carried out using STATA software (Stata Corp. College Station,&#xD;
      Texas, USA).&#xD;
&#xD;
      Sample size Considering that adherence to 70% of the items of an ERAS program determines a&#xD;
      significant reduction in surgical complications after colorectal surgery, an estimation of&#xD;
      the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i.&#xD;
      0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748&#xD;
      (about 874 cases per arm expected in low vs high adherence to ERAS programs).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anastomotic Leakage rate</measure>
    <time_frame>up to 45 days</time_frame>
    <description>Rate of any complication related to the anastomosis after colorectal resection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>up to 45 days</time_frame>
    <description>Rate of any complication after colorectal resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>up to 45 days</time_frame>
    <description>Rate of any death after colorectal resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation rate</measure>
    <time_frame>up to 45 days</time_frame>
    <description>Rate of any unplanned reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>up to 45 days</time_frame>
    <description>Rate of any unplanned readmission after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postoperative hospital stay</measure>
    <time_frame>up to 45 days</time_frame>
    <description>number of days between primary colorectal resection and discharge</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1748</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Anastomotic Leak</condition>
  <condition>Surgery--Complications</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colorectal resections</intervention_name>
    <description>Colorectal resections</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient submitted to elective colorectal resection with anastomosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection&#xD;
             with anastomosis (both intra- and extra-corporeal), including planned Hartmann's&#xD;
             reversals.&#xD;
&#xD;
          2. American Society of Anesthesiologists' (ASA) class I, II or III&#xD;
&#xD;
          3. Elective or delayed urgency surgery&#xD;
&#xD;
          4. Patients' written acceptance to be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. American Society of Anesthesiologists' (ASA) class IV-V&#xD;
&#xD;
          2. Patients with stoma before or at operation&#xD;
&#xD;
          3. Simple stoma closure&#xD;
&#xD;
          4. Transanal procedure&#xD;
&#xD;
          5. Pregnancy&#xD;
&#xD;
          6. Hyperthermic intraperitoneal chemotherapy for carcinomatosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Catarci, MD FACS</last_name>
    <role>Study Chair</role>
    <affiliation>Ospedale C &amp; G Mazzoni - Ascoli Piceno</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gianluca Guercioni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale C &amp; G Mazzoni - Ascoli Piceno</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Catarci, MD FACS</last_name>
    <phone>3298610040</phone>
    <email>marcocatarci@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale Profili - Fabriano (AN) - ASUR MARCHE AV2</name>
      <address>
        <city>Fabriano</city>
        <state>AN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Augusto Verzelli, MD</last_name>
      <email>augustoverzelli@libero.it</email>
    </contact>
    <investigator>
      <last_name>Nancy Cianforlini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale &quot;C. Urbani&quot; Jesi - AV2 - ASUR Marche</name>
      <address>
        <city>Jesi</city>
        <state>AN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Campagnacci, MD</last_name>
      <email>rcampagnacci@libero.it</email>
    </contact>
    <investigator>
      <last_name>Angela Maurizi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e d'Urgenza - Ospedale Regionale &quot;U. Parini&quot; - Aosta</name>
      <address>
        <city>Aosta</city>
        <state>AO</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo Millo, MD</last_name>
      <email>paolomillo@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Elisa Ponte, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ascoli Piceno - AV5 - ASUR Marche</name>
      <address>
        <city>Ascoli Piceno</city>
        <state>AP</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Guercioni, MD</last_name>
      <email>gianmed@libero.it</email>
    </contact>
    <investigator>
      <last_name>Paolo Ciano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - San Benedetto del Tronto (AP) - AV5 - ASUR Marche</name>
      <address>
        <city>San Benedetto Del Tronto</city>
        <state>AP</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Siquini, MD</last_name>
      <email>walter.siquini@sanita.marche.it</email>
    </contact>
    <investigator>
      <last_name>Francesco Luparini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale Universitaria - Ospedale San Salvatore - L'Aquila</name>
      <address>
        <city>L'Aquila</city>
        <state>AQ</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Guadagni, MD</last_name>
      <email>stefano.guadagni@univaq.it</email>
    </contact>
    <investigator>
      <last_name>Marco Clementi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Oncologica - AORN San Giuseppe Moscati - Avellino</name>
      <address>
        <city>Avellino</city>
        <state>AV</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Crafa, MD</last_name>
      <email>crafa@tiscali.it</email>
    </contact>
    <investigator>
      <last_name>Adele Noviello, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinica Chirurgica, Università di Brescia - UOC Chirurgia Generale 3, ASST Spedali Civili di Brescia - Brescia</name>
      <address>
        <city>Brescia</city>
        <state>BS</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gian Luca Baiocchi, MD</last_name>
      <email>gianluca.baiocchi@unibs.it</email>
    </contact>
    <investigator>
      <last_name>Sarah Molfino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale Montichiari (BS) - ASST Spedali Civili di Brescia</name>
      <address>
        <city>Montichiari</city>
        <state>BS</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nereo Vettoretto, MD</last_name>
      <email>nereovet@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Emanuele Botteri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia</name>
      <address>
        <city>Cuneo</city>
        <state>CN</state>
        <zip>12100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FELICE BORGHI</last_name>
      <email>borghi.f@ospedale.cuneo.it</email>
    </contact>
    <investigator>
      <last_name>DESIREE' CIANFLOCCA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale 1 - Chirurgia laparoscopica - Università di Ferrara</name>
      <address>
        <city>Ferrara</city>
        <state>FE</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriele Anania, MD</last_name>
      <email>g.anania@unife.it</email>
    </contact>
    <investigator>
      <last_name>Serena Rubino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC di Chirurgia Addominale IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo - Foggia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>FG</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matteo Scaramuzzi, MD</last_name>
      <email>m.scaramuzzi@operapadrepio.it</email>
    </contact>
    <investigator>
      <last_name>Matteo Tardio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale S. Maria Annunziata - Firenze - ASL Toscana Centro</name>
      <address>
        <city>Firenze</city>
        <state>FI</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Scatizzi, MD</last_name>
      <email>marcoscatizzi60@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Alessandro Falsetto, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lorenzo Pandolfini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale ad Indirizzo Oncologico - IRCCS San Martino IST - Genova</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>STEFANO SCABINI, MD</last_name>
      <email>stefanoscabini@libero.it</email>
    </contact>
    <investigator>
      <last_name>ANTONIO MARTINO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale&quot;San Giovanni di Dio&quot;, ASP di Crotone (KR)</name>
      <address>
        <city>Crotone</city>
        <state>KR</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Brisinda, MD</last_name>
      <email>gbrisin@tin.it</email>
    </contact>
    <investigator>
      <last_name>Maria M Chiarello, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e d'Urgenza - Ospedale Cardinale Panico - Tricase (LE)</name>
      <address>
        <city>Tricase</city>
        <state>LE</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo G Viola, MD</last_name>
      <email>masgiuviola@yahoo.it</email>
    </contact>
    <investigator>
      <last_name>Amedeo Altamura, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - ASST Nord - Sesto San Giovanni (MI)</name>
      <address>
        <city>Sesto San Giovanni</city>
        <state>MI</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianandrea Baldazzi, MD</last_name>
      <email>gbaldazzi@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Diletta Cassini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale di Esine (BS) - ASST Valcamonica</name>
      <address>
        <city>Esine</city>
        <state>NS</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucio Taglietti, MD</last_name>
      <email>lucio.taglietti@unibs.it</email>
    </contact>
    <investigator>
      <last_name>Silvia Ruggiero, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e D'Urgenza - Pescara</name>
      <address>
        <city>Pescara</city>
        <state>PE</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Basti, MD</last_name>
      <email>basti.massimo60@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Valerio Caracino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Foligno (PG) - USL UMBRIA 2</name>
      <address>
        <city>Foligno</city>
        <state>PG</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graziano Ceccarelli, MD</last_name>
      <email>g.cecca2003@libero.it</email>
    </contact>
    <investigator>
      <last_name>Walter Bugiantella, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SC Chirurgia Generale e Oncologica - AO Marche Nord - Pesaro</name>
      <address>
        <city>Pesaro</city>
        <state>PU</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Patriti, MD</last_name>
      <email>albertopatriti@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Valerio Sisti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ragusa</name>
      <address>
        <city>Ragusa</city>
        <state>RG</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Di Mauro, MD</last_name>
      <email>gianluca.dimauro@asp.rg.it</email>
    </contact>
    <investigator>
      <last_name>Agata Ardizzone, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale &quot;Regina Apostolorum&quot; Albano Laziale (RM)</name>
      <address>
        <city>Albano Laziale</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Liverani, MD</last_name>
      <email>andliverani@libero.it</email>
    </contact>
    <investigator>
      <last_name>Tatiana Di Cesare, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e d'Urgenza - Policlinico Casilino - Roma</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graziano Longo, MD</last_name>
      <email>grazianolongo@mac.com</email>
    </contact>
    <investigator>
      <last_name>Federico Tomassini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e D'Urgenza . Azienda Ospedaliera San Camillo Forlanini Roma</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierluigi Marini, MD</last_name>
      <email>marinipierluigi6@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Graziella Attinà, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e Oncologica - Ospedale San Filippo Neri - ASL Roma1</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Mancini, MD</last_name>
      <email>stef.mancini@virgilio.it</email>
    </contact>
    <investigator>
      <last_name>Carla Di Cosimo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOS Chirurgia Geriatrica - Università Campus BioMedico - Roma</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Caricato, MD</last_name>
      <email>m.caricato@unicampus.it</email>
    </contact>
    <investigator>
      <last_name>Gabriella T Capolupo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOSD Chirurgia Mininvasiva e dell'Apparato Digerente - Università Tor Vergata - Roma</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe S Sica, MD</last_name>
      <email>sigisica@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Claudio Arcudi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale, Ospedale &quot;Ceccarini&quot; di Riccione (RN)</name>
      <address>
        <city>Riccione</city>
        <state>RN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Lucchi, MD</last_name>
      <email>andrea.lucchi@auslromagna.it</email>
    </contact>
    <investigator>
      <last_name>Giacomo Martorelli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e d'urgenza, Rimini, Novafeltria, Santarcangelo</name>
      <address>
        <city>Rimini</city>
        <state>RN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Garulli, MD</last_name>
      <email>lucagarulli@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Basilio Pirrera, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale I - Ospedale di La Spezia - ASL5 Spezzino</name>
      <address>
        <city>La Spezia</city>
        <state>SP</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Berti, MD</last_name>
      <email>stefano.berti@asl5.liguria.it</email>
    </contact>
    <investigator>
      <last_name>Andrea Gennai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale 1 - Ospedale S. Chiara - APSS Trento</name>
      <address>
        <city>Trento</city>
        <state>TN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Carrara, MD</last_name>
      <email>Alessandro.Carrara@apss.tn.it</email>
    </contact>
    <investigator>
      <last_name>Michele Motter, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuseppe Tirone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale e Mininvasiva, Ospedale San Camillo di Trento</name>
      <address>
        <city>Trento</city>
        <state>TN</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Di Leo, MD</last_name>
      <email>direttorechirurgia@figliesancamillo.it</email>
    </contact>
    <investigator>
      <last_name>Jacopo Adreucetti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale &quot;E. Agnelli&quot; di Pinerolo (TO) - ASL TO3</name>
      <address>
        <city>Pinerolo</city>
        <state>TO</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Muratore, MD</last_name>
      <email>amuratore67@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Patrizia Marsanic, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Conegliano Veneto (TV) AULSS2 Marca trevigiana</name>
      <address>
        <city>Conegliano</city>
        <state>TV</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maurizio Pavanello, MD</last_name>
      <email>mpavanello@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Carlo Di Marco, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Ospedale Sacro Cuore Don Calabria Negrar Verona</name>
      <address>
        <city>Negrar</city>
        <state>VR</state>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GIACOMO RUFFO, MD</last_name>
      <email>giacomo.ruffo@sacrocuore.it</email>
    </contact>
    <investigator>
      <last_name>ELISA BERTOCCHI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.O.C. di Chirurgia Generale e dell'Esofago e Stomaco - AOUI di Verona</name>
      <address>
        <city>Verona</city>
        <state>VR</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Di Leo, MD</last_name>
      <email>direttorechirurgia@figliesancamillo.it</email>
    </contact>
    <investigator>
      <last_name>Daniele Zigiotto, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale Epatobiliare - AOUI Verona</name>
      <address>
        <city>Verona</city>
        <state>VR</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corrado Pedrazzani, MD</last_name>
      <email>corrado.pedrazzani@univr.it</email>
    </contact>
    <investigator>
      <last_name>Giulia Turri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale Oncologica - Azienda Ospedaliera Belcolle - Viterbo</name>
      <address>
        <city>Viterbo</city>
        <state>VT</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Macarone Palmieri, MD</last_name>
      <email>raffaele.macaronepalmieri@aslvt.it</email>
    </contact>
    <investigator>
      <last_name>Pietro Amodio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SOC Chirurgia Colorettale - Istituto Nazionale dei Tumori - IRCCS Fondazione &quot;G.Pascale&quot; - Napoli</name>
      <address>
        <city>Napoli</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PAOLO DEL RIO, MD</last_name>
      <email>p.delrio@istitutotumori.na.it</email>
    </contact>
    <investigator>
      <last_name>UGO PACE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Chirurgia Generale - Pozzuoli (NA) - ASL Napoli2 nord</name>
      <address>
        <city>Pozzuoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felice Pirozzi, MD</last_name>
      <email>felice.pirozzi@aslnapoli2nord.it</email>
    </contact>
    <investigator>
      <last_name>Antonio Sciuto, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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    <PMID>28097305</PMID>
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  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 8, 2018</last_update_submitted>
  <last_update_submitted_qc>December 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale C &amp; G Mazzoni</investigator_affiliation>
    <investigator_full_name>Marco Catarci</investigator_full_name>
    <investigator_title>Director, General Surgery Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Anastomotic Leak</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771456
org study id: 2.0
nct id: NCT03771456
lead sponsor: 
Prospective observational multicenter study on the influence of adherence to enhanced
      recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission,
      reoperation rates and length of postoperative stay) after elective colorectal surgery in
      Italy.
BACKGROUND

      Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The
      overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when
      performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses
      (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks
      usually become apparent between five and seven days postoperatively. Almost half of all leaks
      occur after the patient has been discharged, and up to 12 percent occur after postoperative
      day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and
      nonspecific symptoms attributable to other postoperative infectious complications. Small,
      contained leaks present later in the clinical course and may be difficult to distinguish from
      postoperative abscesses by radiologic imaging, making the diagnosis uncertain and
      underreported.

      There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97
      studies, as an example, 56 different definitions of an anastomotic leak were used. The
      majority of reports define an anastomotic leak using clinical signs, radiographic findings,
      and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia,
      Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid
      collections, Gas containing collections. The intraoperative findings include: Gross enteric
      spillage, Anastomotic disruption.

      Risk factors for a dehiscence and leak are classified according to the site of the
      anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients
      undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a
      significantly increased risk of anastomotic leak with extraperitoneal compared with
      intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).

      Major risk factors for an extraperitoneal AL include: The distance of the anastomosis from
      the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from
      the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia,
      Male gender, Obesity.

      Major risk factors for an intraperitoneal AL include: American Society of Anesthesiologists
      (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic
      anastomosis.

      Controversial, inconclusive, or pertinent negative associations between the following
      variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma,
      Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation,
      Nutritional status, Perioperative corticosteroids.

      Enhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively
      studied during the last 20 years. It is now clear that they offer a consistent reduction of
      overall morbidity rates, postoperative length of stay and costs, and that there is a clear
      dose-effect relation between adherence to at least 60-70% of the program items and these
      outcomes. On the other hand, little is known concerning the potential benefit of ERAS
      programs over AL rates or if adherence to specific items of the program may reduce AL rates.

      Therefore, the investigators planned this study to prospectively evaluate AL rates after
      colorectal resections and their interaction with known risk factors and ERAS program items.

      METHODS

      Prospective enrollment from January to December 2019 in 41 Italian surgical centers. All
      patients undergoing elective colorectal surgery with anastomosis will be included in a
      prospective database after having provided a written informed consent. A total of 1,750
      patients is expected based on a mean of 43 cases/year per center.

      Outcome measures

        1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional
           status, diabetes, cardiovascular disease, chronic liver disease, renal failure,
           inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)

        2. Operative parameters (approach, procedure, anastomotic technique, length of operation,
           disease stage)

        3. ERAS program items (prehabilitation, counseling, nutritional evaluation,
           immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel
           preparation, preoperative carbohydrates load, standardized anesthesia protocol,
           restrictive i.v. fluid administration, control of body temperature, nausea and vomit
           prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of
           surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of
           anesthesia, early removal of urinary catheter, early mobilization, early oral intake of
           fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional
           supplements, prepare for early discharge, audit).

      Endpoints

        1. Anastomotic leakage rate

        2. Minor and major complications

        3. Length of postoperative hospital stay

        4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific
           and intraoperative risk factors will be recorded: gender, body mass index, nutritional
           status according to the Mini Nutritional Assessment short-form, surgical indication
           (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative
           albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory
           disease, American Society of Anesthesia class, bowel preparation (decision made by
           operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique
           (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of
           drainage, and perioperative blood transfusion(s). During the postoperative period,
           patients will be examined by the attending surgeon daily. Fever (central temperature >
           38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if
           present) will be recorded daily. The attending surgeon will make any decision for
           complementary exams and imaging according to his own criteria. The rate of any
           complication will be calculated and graded including all leaks (independently of
           clinical significance), wound infection (according to the definitions of the Centers for
           Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and
           physical and radiological examinations), central line infection (positive blood
           culture), urinary tract infection (positive urine culture with bacterial count ).
           Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from
           the hospital.

      Main endpoint is anastomotic dehiscence (intended as any deviation from the planned
      postoperative course related to the anastomosis, or presence of pus or enteric contents
      within the drains, presence of abdominal or pelvic collection in the area of the anastomosis
      on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of
      contrast through the anastomosis during enema or evident anastomotic dehiscence at
      reoperation for postoperative peritonitis). Thus, all detected leaks will be considered
      independently of clinical significance. No imaging will be performed routinely in order to
      search for leakage.

      Secondary endpoints are morbidity and mortality rates, postoperative length of stay,
      readmission and reoperation rates.

      After anonymization, all data of each single case will be prospectively uploaded by every
      local investigator on a protected web-based database. Thereafter, all data will be
      incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy,
      that will be addressed and solved through strict cooperation between chief investigator, data
      manager and participating center.

      Statistical Analysis Quantitative values will be expressed as mean ± standard deviation,
      median and range; categorical data with percentage frequencies. Mean values of duration of
      stay will be compared according to the presence or absence of fistulas using Student's
      two-sided t test (allowing for heterogeneity of variances) or with a non-parametric
      Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to
      assess risk factors for leakage and overall complications. The odds ratio (OR) will be
      presented followed by its 95% confidence interval (95% CI). For all statistical tests the
      significant level is fixed at p < .05.

      Statistical analyses will be carried out using STATA software (Stata Corp. College Station,
      Texas, USA).

      Sample size Considering that adherence to 70% of the items of an ERAS program determines a
      significant reduction in surgical complications after colorectal surgery, an estimation of
      the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i.
      0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748
      (about 874 cases per arm expected in low vs high adherence to ERAS programs).
observational model: Cohort
time perspective: Prospective
measure: Anastomotic Leakage rate
time frame: up to 45 days
description: Rate of any complication related to the anastomosis after colorectal resection
measure: Morbidity rate
time frame: up to 45 days
description: Rate of any complication after colorectal resection
measure: Mortality rate
time frame: up to 45 days
description: Rate of any death after colorectal resection
measure: Reoperation rate
time frame: up to 45 days
description: Rate of any unplanned reoperation
measure: Readmission rate
time frame: up to 45 days
description: Rate of any unplanned readmission after discharge
measure: Length of postoperative hospital stay
time frame: up to 45 days
description: number of days between primary colorectal resection and discharge
intervention type: Procedure
intervention name: Colorectal resections
description: Colorectal resections
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marco Catarci, MD FACS
role: Study Chair
affiliation: Ospedale C & G Mazzoni - Ascoli Piceno
last name: Gianluca Guercioni, MD
role: Principal Investigator
affiliation: Ospedale C & G Mazzoni - Ascoli Piceno
last name: Marco Catarci, MD FACS
phone: 3298610040
email: marcocatarci@gmail.com
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country: Italy
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PMID: 1334988
responsible party type: Principal Investigator
investigator affiliation: Ospedale C & G Mazzoni
investigator full name: Marco Catarci
investigator title: Director, General Surgery Unit
mesh term: Colorectal Neoplasms
mesh term: Anastomotic Leak
sharing ipd: Undecided