<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/NCT03760939</url>
  </required_header>
  <id_info>
    <org_study_id>18-001</org_study_id>
    <nct_id>NCT03760939</nct_id>
  </id_info>
  <brief_title>Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care</brief_title>
  <acronym>Colon-Ambu</acronym>
  <official_title>Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IHU Strasbourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IHU Strasbourg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and&#xD;
      hospital length of stay without increasing the rate of re-hospitalization. It reduces&#xD;
      psychologic stress caused by surgery and decreases postoperative complications about 50 %,&#xD;
      especially in colorectal surgery. ERAS is now the object of several Good Practices&#xD;
      Recommendations and is about to become the reference strategy.&#xD;
&#xD;
      The development of ambulatory surgery is a French national concern. Its interest has been&#xD;
      demonstrated in many surgical fields. It requires a reflection centered on the patient and a&#xD;
      health care pathway organization involving all health care actors.&#xD;
&#xD;
      While hospitalization is still the standard practice for colonic surgery, the objective of&#xD;
      this study is to evaluate the medical and economic impact of an ambulatory care for&#xD;
      colorectal surgery.&#xD;
&#xD;
      Ambulatory care will be compared to standard hospitalization of patients who benefit from the&#xD;
      ERAS program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and&#xD;
      hospital length of stay without increasing the rate of re-hospitalization. It reduces&#xD;
      psychologic stress caused by surgery and decreases postoperative complications about 50 %,&#xD;
      especially in colorectal surgery. ERAS is now the object of several Good Practices&#xD;
      Recommendations and is about to become the reference strategy.&#xD;
&#xD;
      The development of ambulatory surgery is a French national concern. Its interest has been&#xD;
      demonstrated in many surgical fields. It requires a reflection centered on the patient and a&#xD;
      health care pathway organization involving all health care actors. Multiple interests have&#xD;
      been shown:&#xD;
&#xD;
        -  Equivalent mortality and/or morbidity compared with standard hospitalizations&#xD;
&#xD;
        -  Medical and psychological benefits&#xD;
&#xD;
        -  Individualized and less invasive health care pathways, in favor of patient's autonomy&#xD;
&#xD;
        -  Multidisciplinary approach and innovative care&#xD;
&#xD;
        -  Heath care costs management (decrease of hospital length of stay, optimization of&#xD;
           operating rooms).&#xD;
&#xD;
      Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD&#xD;
      in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in&#xD;
      few expert centers with significant experience (more than 100 patients in Le Havre and more&#xD;
      than 85 patients in Lyon) but several human and organizational limitations slow this&#xD;
      innovative care.&#xD;
&#xD;
      The risk of complications does not seem to be increased on condition of anticipate and&#xD;
      provide a postoperative follow-up at home.&#xD;
&#xD;
      While hospitalization is still the standard practice for colonic surgery, the objective of&#xD;
      this study is to evaluate the medical and economic impact of an ambulatory care for&#xD;
      colorectal surgery.&#xD;
&#xD;
      Ambulatory care will be compared to standard hospitalization of patients who benefit from the&#xD;
      ERAS program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean cost evaluation</measure>
    <time_frame>1 month</time_frame>
    <description>Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale</measure>
    <time_frame>7 and 30 days</time_frame>
    <description>The EQ-5D Quality of Life scale consists of :&#xD;
(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.&#xD;
(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state&quot; and &quot;Worst imaginable health state&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean hospital length of stay</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Mean hospital length of stay for the &quot;standard hospitalization&quot; group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory colectomies rate</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Rate of ambulatory colectomies compared to the total number of colectomies performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory care failure rate</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duty desk call</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Number of patients who called the duty desk (or for whom the duty desk has been called)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time period required for a postoperative complication care</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Mean time period required for a postoperative complication care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital re-admissions rate</measure>
    <time_frame>30 days</time_frame>
    <description>Rate of hospital re-admissions related to postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications (Morbidity)</measure>
    <time_frame>30 days</time_frame>
    <description>Rate of complications related or not to surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of death (Mortality)</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients who died within the individual participation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications rate</measure>
    <time_frame>30 days</time_frame>
    <description>Clinical and economic evaluation of postoperative complications rates difference between &quot;ambulatory care&quot; group and &quot;standard hospitalization&quot; group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications severity classification</measure>
    <time_frame>30 days</time_frame>
    <description>Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of complication severity according to Clavien classification</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Severity of the complications will be evaluated according to the Clavien classification from Grade I &quot;Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions&quot; to Grade V &quot;Death of a patient&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean additional hospital length of stay</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Clinical and economic evaluation of hospital length of stay related to complications difference between &quot;ambulatory care&quot; group and &quot;standard hospitalization&quot; group (additional hospitalizations, extension of hospitalization or new hospitalization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs related to postoperative complications</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Costs related to postoperative complications difference between &quot;ambulatory care&quot; group and &quot;standard hospitalization&quot; group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs related to the management of postoperative complications</measure>
    <time_frame>2 years and 3 months</time_frame>
    <description>Overall costs are evaluated by individual costs of:&#xD;
unscheduled consultations,&#xD;
surgical treatment,&#xD;
medicated treatment&#xD;
hospitalisation's duration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Ambulatory care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colorectal surgery in ambulatory care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard hospitalization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical and economical evaluation</intervention_name>
    <description>Evaluation of the clinical and the economical impact of a colorectal surgery</description>
    <arm_group_label>Ambulatory care</arm_group_label>
    <arm_group_label>Standard hospitalization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 18 years old&#xD;
&#xD;
          -  Patient able to understand the objectives and risks related to the trial&#xD;
&#xD;
          -  Patient able to give written informed consent&#xD;
&#xD;
          -  Patient able to understand and accept the health care program&#xD;
&#xD;
          -  Isolated colonic lesion located on the colon or the upper rectum&#xD;
&#xD;
          -  Any neoplastic or non-neoplastic colonic pathology&#xD;
&#xD;
          -  Colonic surgery except resection without continuity interruption (e.g. low cecum&#xD;
             resection, partial colectomy, suture for polyp)&#xD;
&#xD;
          -  Moderate and/or controlled comorbidities&#xD;
&#xD;
          -  No history of multiple laparotomies&#xD;
&#xD;
          -  No psychosocial distress&#xD;
&#xD;
          -  No living alone patient&#xD;
&#xD;
          -  Patient registered with the French social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient in exclusion period of another clinical study&#xD;
&#xD;
          -  Emergency surgical procedure&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Presence of an uncontrolled preoperative anemia&#xD;
&#xD;
          -  Effective anticoagulation treatment, impossible to suspend&#xD;
&#xD;
          -  Kidney failure (treated by dialysis)&#xD;
&#xD;
          -  Hepatic cirrhosis&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Patient in custody&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Poor general condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Didier Mutter, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Didier Mutter, MD, PhD</last_name>
    <phone>+33(0)369550553</phone>
    <email>didier.mutter@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Didier Mutter, MD, PhD</last_name>
      <phone>+33 3 69 55 05 53</phone>
      <email>didier.mutter@chru-strasbourg.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.has-sante.fr/portail/jcms/c_1763416/fr/programmes-de-recuperation-amelioree-apres-chirurgie-raac</url>
    <description>Haute Autorité de Santé, Rapport d'orientation : Programmes de récupération améliorée après chirurgie (RAAC) : état des lieux et perspectives, Juin 2016</description>
  </link>
  <link>
    <url>http://circulaire.legifrance.gouv.fr/index.php?action=afficherCirculaire&amp;hit=1&amp;r=40158</url>
    <description>INSTRUCTION N° DGOS/R3/2015/296 du 28 septembre 2015 relative aux objectifs et orientations stratégiques du programme national de développement de la chirurgie ambulatoire pour la période 2015-2020</description>
  </link>
  <link>
    <url>https://www.has-sante.fr/portail/jcms/c_1241930/fr/ensemble-pour-le-developpement-de-la-chirurgie-ambulatoire</url>
    <description>Haute Autorité de santé / Agence Nationale d'Appui à la Performance des établissements de santé et médico-sociaux, Ensemble pour le développement de la chirurgie ambulatoire, Socle de connaissances, Avril 2012</description>
  </link>
  <link>
    <url>https://www.has-sante.fr/portail/upload/docs/application/pdf/2015-03/methodes_et_outils_construction_dun_outil_de_micro-costing_en_chirurgie_ambulatoire.pdf</url>
    <description>Haute Autorité de Santé, Construction d'un outil de micro-costing en chirurgie ambulatoire, Méthodologie et résultats des sites pilotes, Janvier 2015</description>
  </link>
  <reference>
    <citation>Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.</citation>
    <PMID>25661787</PMID>
  </reference>
  <reference>
    <citation>Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.</citation>
    <PMID>27671006</PMID>
  </reference>
  <reference>
    <citation>Slim K; Groupe GRACE (Groupe francophone de rehabilitation amelioree apres chirurgie); Amalberti R. Ambulatory colectomy: no innovation without evaluation. J Visc Surg. 2015 Feb;152(1):1-3. doi: 10.1016/j.jviscsurg.2015.01.001. Epub 2015 Jan 31. No abstract available.</citation>
    <PMID>25650365</PMID>
  </reference>
  <reference>
    <citation>Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.</citation>
    <PMID>16775831</PMID>
  </reference>
  <reference>
    <citation>Walter CJ, Collin J, Dumville JC, Drew PJ, Monson JR. Enhanced recovery in colorectal resections: a systematic review and meta-analysis. Colorectal Dis. 2009 May;11(4):344-53. doi: 10.1111/j.1463-1318.2009.01789.x. Epub 2009 Feb 4. Erratum In: Colorectal Dis. 2010 Jul;12(7):728.</citation>
    <PMID>19207699</PMID>
  </reference>
  <reference>
    <citation>Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.</citation>
    <PMID>19415308</PMID>
  </reference>
  <reference>
    <citation>Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.</citation>
    <PMID>20116145</PMID>
  </reference>
  <reference>
    <citation>Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.</citation>
    <PMID>21236454</PMID>
  </reference>
  <reference>
    <citation>Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.</citation>
    <PMID>21328298</PMID>
  </reference>
  <reference>
    <citation>Slim K, Delaunay L, Joris J, Leonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de rehabilitation amelioree apres chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. No abstract available.</citation>
    <PMID>27316295</PMID>
  </reference>
  <reference>
    <citation>Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.</citation>
    <PMID>26913728</PMID>
  </reference>
  <reference>
    <citation>Lawrence JK, Keller DS, Samia H, Ermlich B, Brady KM, Nobel T, Stein SL, Delaney CP. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013 Mar;216(3):390-4. doi: 10.1016/j.jamcollsurg.2012.12.014. Epub 2013 Jan 23.</citation>
    <PMID>23352608</PMID>
  </reference>
  <reference>
    <citation>Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.</citation>
    <PMID>7891489</PMID>
  </reference>
  <reference>
    <citation>Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.</citation>
    <PMID>19571699</PMID>
  </reference>
  <reference>
    <citation>Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.</citation>
    <PMID>20734083</PMID>
  </reference>
  <reference>
    <citation>Rogers JP, Dobradin A, Kar PM, Alam SE. Overnight hospital stay after colon surgery for adenocarcinoma. JSLS. 2012 Apr-Jun;16(2):333-6. doi: 10.4293/108680812x13427982376789.</citation>
    <PMID>23477191</PMID>
  </reference>
  <reference>
    <citation>Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.</citation>
    <PMID>23925012</PMID>
  </reference>
  <reference>
    <citation>Martin-Ferrero MA, Faour-Martin O, Simon-Perez C, Perez-Herrero M, de Pedro-Moro JA. Ambulatory surgery in orthopedics: experience of over 10,000 patients. J Orthop Sci. 2014 Mar;19(2):332-338. doi: 10.1007/s00776-013-0501-3. Epub 2014 Jan 7.</citation>
    <PMID>24395115</PMID>
  </reference>
  <reference>
    <citation>Verrier JF, Paget C, Perlier F, Demesmay F. How to introduce a program of Enhanced Recovery after Surgery? The experience of the CAPIO group. J Visc Surg. 2016 Dec;153(6S):S33-S39. doi: 10.1016/j.jviscsurg.2016.10.001. Epub 2016 Nov 16.</citation>
    <PMID>27863944</PMID>
  </reference>
  <reference>
    <citation>Daams F, Wu Z, Lahaye MJ, Jeekel J, Lange JF. Prediction and diagnosis of colorectal anastomotic leakage: A systematic review of literature. World J Gastrointest Surg. 2014 Feb 27;6(2):14-26. doi: 10.4240/wjgs.v6.i2.14.</citation>
    <PMID>24600507</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal surgery</keyword>
  <keyword>Ambulatory care</keyword>
  <keyword>Medical and economic evaluation</keyword>
  <!-- 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/NCT03760939
org study id: 18-001
nct id: NCT03760939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and
      hospital length of stay without increasing the rate of re-hospitalization. It reduces
      psychologic stress caused by surgery and decreases postoperative complications about 50 %,
      especially in colorectal surgery. ERAS is now the object of several Good Practices
      Recommendations and is about to become the reference strategy.

      The development of ambulatory surgery is a French national concern. Its interest has been
      demonstrated in many surgical fields. It requires a reflection centered on the patient and a
      health care pathway organization involving all health care actors.

      While hospitalization is still the standard practice for colonic surgery, the objective of
      this study is to evaluate the medical and economic impact of an ambulatory care for
      colorectal surgery.

      Ambulatory care will be compared to standard hospitalization of patients who benefit from the
      ERAS program.
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and
      hospital length of stay without increasing the rate of re-hospitalization. It reduces
      psychologic stress caused by surgery and decreases postoperative complications about 50 %,
      especially in colorectal surgery. ERAS is now the object of several Good Practices
      Recommendations and is about to become the reference strategy.

      The development of ambulatory surgery is a French national concern. Its interest has been
      demonstrated in many surgical fields. It requires a reflection centered on the patient and a
      health care pathway organization involving all health care actors. Multiple interests have
      been shown:

        -  Equivalent mortality and/or morbidity compared with standard hospitalizations

        -  Medical and psychological benefits

        -  Individualized and less invasive health care pathways, in favor of patient's autonomy

        -  Multidisciplinary approach and innovative care

        -  Heath care costs management (decrease of hospital length of stay, optimization of
           operating rooms).

      Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD
      in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in
      few expert centers with significant experience (more than 100 patients in Le Havre and more
      than 85 patients in Lyon) but several human and organizational limitations slow this
      innovative care.

      The risk of complications does not seem to be increased on condition of anticipate and
      provide a postoperative follow-up at home.

      While hospitalization is still the standard practice for colonic surgery, the objective of
      this study is to evaluate the medical and economic impact of an ambulatory care for
      colorectal surgery.

      Ambulatory care will be compared to standard hospitalization of patients who benefit from the
      ERAS program.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mean cost evaluation
time frame: 1 month
description: Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
measure: Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
time frame: 7 and 30 days
description: The EQ-5D Quality of Life scale consists of :
(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state" and "Worst imaginable health state".
measure: Mean hospital length of stay
time frame: 2 years and 3 months
description: Mean hospital length of stay for the "standard hospitalization" group
measure: Ambulatory colectomies rate
time frame: 2 years and 3 months
description: Rate of ambulatory colectomies compared to the total number of colectomies performed
measure: Ambulatory care failure rate
time frame: 2 years and 3 months
description: Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery
measure: Duty desk call
time frame: 2 years and 3 months
description: Number of patients who called the duty desk (or for whom the duty desk has been called)
measure: Mean time period required for a postoperative complication care
time frame: 2 years and 3 months
description: Mean time period required for a postoperative complication care
measure: Hospital re-admissions rate
time frame: 30 days
description: Rate of hospital re-admissions related to postoperative complications
measure: Rate of complications (Morbidity)
time frame: 30 days
description: Rate of complications related or not to surgery
measure: Rate of death (Mortality)
time frame: 30 days
description: Number of patients who died within the individual participation period
measure: Complications rate
time frame: 30 days
description: Clinical and economic evaluation of postoperative complications rates difference between "ambulatory care" group and "standard hospitalization" group
measure: Complications severity classification
time frame: 30 days
description: Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification
measure: Evaluation of complication severity according to Clavien classification
time frame: 2 years and 3 months
description: Severity of the complications will be evaluated according to the Clavien classification from Grade I "Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions" to Grade V "Death of a patient"
measure: Mean additional hospital length of stay
time frame: 2 years and 3 months
description: Clinical and economic evaluation of hospital length of stay related to complications difference between "ambulatory care" group and "standard hospitalization" group (additional hospitalizations, extension of hospitalization or new hospitalization).
measure: Costs related to postoperative complications
time frame: 2 years and 3 months
description: Costs related to postoperative complications difference between "ambulatory care" group and "standard hospitalization" group
measure: Costs related to the management of postoperative complications
time frame: 2 years and 3 months
description: Overall costs are evaluated by individual costs of:
unscheduled consultations,
surgical treatment,
medicated treatment
hospitalisation's duration
arm group label: Ambulatory care
arm group type: Experimental
description: Colorectal surgery in ambulatory care
arm group label: Standard hospitalization
arm group type: Other
description: Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching.
intervention type: Other
intervention name: Clinical and economical evaluation
description: Evaluation of the clinical and the economical impact of a colorectal surgery
arm group label: Ambulatory care
arm group label: Standard hospitalization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Didier Mutter, MD, PhD
role: Principal Investigator
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
last name: Didier Mutter, MD, PhD
phone: +33(0)369550553
email: didier.mutter@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
country: France
url: https://www.has-sante.fr/portail/jcms/c_1763416/fr/programmes-de-recuperation-amelioree-apres-chirurgie-raac
description: Haute Autorité de Santé, Rapport d'orientation : Programmes de récupération améliorée après chirurgie (RAAC) : état des lieux et perspectives, Juin 2016
url: http://circulaire.legifrance.gouv.fr/index.php?action=afficherCirculaire&hit=1&r=40158
description: INSTRUCTION N° DGOS/R3/2015/296 du 28 septembre 2015 relative aux objectifs et orientations stratégiques du programme national de développement de la chirurgie ambulatoire pour la période 2015-2020
url: https://www.has-sante.fr/portail/jcms/c_1241930/fr/ensemble-pour-le-developpement-de-la-chirurgie-ambulatoire
description: Haute Autorité de santé / Agence Nationale d'Appui à la Performance des établissements de santé et médico-sociaux, Ensemble pour le développement de la chirurgie ambulatoire, Socle de connaissances, Avril 2012
url: https://www.has-sante.fr/portail/upload/docs/application/pdf/2015-03/methodes_et_outils_construction_dun_outil_de_micro-costing_en_chirurgie_ambulatoire.pdf
description: Haute Autorité de Santé, Construction d'un outil de micro-costing en chirurgie ambulatoire, Méthodologie et résultats des sites pilotes, Janvier 2015
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responsible party type: Sponsor