<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/NCT03815851</url>
  </required_header>
  <id_info>
    <org_study_id>jinlingH201608</org_study_id>
    <nct_id>NCT03815851</nct_id>
  </id_info>
  <brief_title>Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery</brief_title>
  <acronym>RBPD</acronym>
  <official_title>Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI et al) in Crohn's Patients After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For patients with Crohn's diseases，whether prophylactic abdominal drainage is necessary need&#xD;
      further exploration. the present study is focusing on the necessity of prophylactic abdominal&#xD;
      drainage in CD patients after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the past decades, surgical dogma meant the correct placement of a prophylactic drain, with&#xD;
      the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation&#xD;
      and avoiding potential postoperative ascites. However, recent randomized controlled trials&#xD;
      (RCTs) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits&#xD;
      on postoperative outcomes.&#xD;
&#xD;
      Crohn's disease (CD), which is definitely different from CRC, is a chronic inflammatory&#xD;
      disease with unknown pathogenesis. CD itself was the independent risk factor of multiple&#xD;
      postoperative complications, including anastomotic leakage, intraperitoneal abscess and&#xD;
      catheter-associated bloodstream infection.&#xD;
&#xD;
      In the present RCT, we hypothesize that non-prophylactic peritoneal drainage is associated&#xD;
      with increased incidence of postoperative non-septic complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 6, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Investigators, surgical team and patients were not blinded to the assignment. In the the drain group, a 28 G latex tube was placed in the pelvic cavity intraoperatively and in the no-drain group, no drain was positioned. 30-day postoperative complications were assessed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of prolonged postoperative ileus</measure>
    <time_frame>postoperative 30 days</time_frame>
    <description>incidence of prolonged postoperative ileus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence</measure>
    <time_frame>postoperative 30 days and 1 year after surgery for endoscopic recurrence.</time_frame>
    <description>time to first passage of flatus and stool, pain relief, postoperative length of stay (LOS), postoperative complications (defined as Clavien-Dindo) within 30 days after surgery, incisional SSIs, readmission rates, medical costs,blood markers,endoscopic recurrence at the anastomosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Drain group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Place prophylactic drainage after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-drain group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Not place prophylactic drainage after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>prophylactic drainage</intervention_name>
    <description>place prophylactic drainage after surgery</description>
    <arm_group_label>Drain group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>no prophylactic drainage</intervention_name>
    <description>Not place prophylactic drainage after surgery</description>
    <arm_group_label>No-drain group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to&#xD;
             2 undergoing elective small bowel or ileocecal resection and anastomosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy,&#xD;
             strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia,&#xD;
             diabetes or hyperglycemia (fasting plasma glucose &gt;126 mg/dL), as well as chronic&#xD;
             systemic disease of cardiovascular, respiratory et al.&#xD;
&#xD;
          -  Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4&#xD;
             weeks before surgery; patients who received steroids, biologics or gastrointestinal&#xD;
             motility drugs within 4 w prior to surgery; patients who remained on steroids within 1&#xD;
             day before surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>weiming zhu</last_name>
    <role>Study Chair</role>
    <affiliation>Jinling Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jinling Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</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">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Zhu Weiming</investigator_full_name>
    <investigator_title>the ethics committee of the hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <!-- 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/NCT03815851
org study id: jinlingH201608
nct id: NCT03815851
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
For patients with Crohn's diseases，whether prophylactic abdominal drainage is necessary need
      further exploration. the present study is focusing on the necessity of prophylactic abdominal
      drainage in CD patients after surgery.
In the past decades, surgical dogma meant the correct placement of a prophylactic drain, with
      the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation
      and avoiding potential postoperative ascites. However, recent randomized controlled trials
      (RCTs) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits
      on postoperative outcomes.

      Crohn's disease (CD), which is definitely different from CRC, is a chronic inflammatory
      disease with unknown pathogenesis. CD itself was the independent risk factor of multiple
      postoperative complications, including anastomotic leakage, intraperitoneal abscess and
      catheter-associated bloodstream infection.

      In the present RCT, we hypothesize that non-prophylactic peritoneal drainage is associated
      with increased incidence of postoperative non-septic complications.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Randomized Clinical Trial
primary purpose: Prevention
masking: None (Open Label)
masking description: Investigators, surgical team and patients were not blinded to the assignment. In the the drain group, a 28 G latex tube was placed in the pelvic cavity intraoperatively and in the no-drain group, no drain was positioned. 30-day postoperative complications were assessed.
measure: incidence of prolonged postoperative ileus
time frame: postoperative 30 days
description: incidence of prolonged postoperative ileus
measure: recurrence
time frame: postoperative 30 days and 1 year after surgery for endoscopic recurrence.
description: time to first passage of flatus and stool, pain relief, postoperative length of stay (LOS), postoperative complications (defined as Clavien-Dindo) within 30 days after surgery, incisional SSIs, readmission rates, medical costs,blood markers,endoscopic recurrence at the anastomosis.
arm group label: Drain group
arm group type: Other
description: Place prophylactic drainage after surgery.
arm group label: No-drain group
arm group type: Other
description: Not place prophylactic drainage after surgery.
intervention type: Device
intervention name: prophylactic drainage
description: place prophylactic drainage after surgery
arm group label: Drain group
intervention type: Device
intervention name: no prophylactic drainage
description: Not place prophylactic drainage after surgery
arm group label: No-drain group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: weiming zhu
role: Study Chair
affiliation: Jinling Hospital, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Zhu Weiming
investigator title: the ethics committee of the hospital
mesh term: Crohn Disease
mesh term: Postoperative Complications