Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery (RBPD)
Primary Purpose
Crohn's Disease
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prophylactic drainage
no prophylactic drainage
Sponsored by
About this trial
This is an interventional prevention trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.
Exclusion Criteria:
- Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose >126 mg/dL), as well as chronic systemic disease of cardiovascular, respiratory et al.
- Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.
Sites / Locations
- Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Drain group
No-drain group
Arm Description
Place prophylactic drainage after surgery.
Not place prophylactic drainage after surgery.
Outcomes
Primary Outcome Measures
incidence of prolonged postoperative ileus
incidence of prolonged postoperative ileus
Secondary Outcome Measures
recurrence
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.
Full Information
NCT ID
NCT03815851
First Posted
January 22, 2019
Last Updated
March 28, 2022
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03815851
Brief Title
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
Acronym
RBPD
Official Title
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI et al) in Crohn's Patients After Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Clinical Trial
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.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drain group
Arm Type
Other
Arm Description
Place prophylactic drainage after surgery.
Arm Title
No-drain group
Arm Type
Other
Arm Description
Not place prophylactic drainage after surgery.
Intervention Type
Device
Intervention Name(s)
prophylactic drainage
Intervention Description
place prophylactic drainage after surgery
Intervention Type
Device
Intervention Name(s)
no prophylactic drainage
Intervention Description
Not place prophylactic drainage after surgery
Primary Outcome Measure Information:
Title
incidence of prolonged postoperative ileus
Description
incidence of prolonged postoperative ileus
Time Frame
postoperative 30 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
postoperative 30 days and 1 year after surgery for endoscopic recurrence.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.
Exclusion Criteria:
Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose >126 mg/dL), as well as chronic systemic disease of cardiovascular, respiratory et al.
Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
weiming zhu
Organizational Affiliation
Jinling Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
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