Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
RBPD
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2016
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 6, 2022
March 1, 2022
5.1 years
January 22, 2019
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of prolonged postoperative ileus
incidence of prolonged postoperative ileus
postoperative 30 days
Secondary Outcomes (1)
recurrence
postoperative 30 days and 1 year after surgery for endoscopic recurrence.
Study Arms (2)
Drain group
OTHERPlace prophylactic drainage after surgery.
No-drain group
OTHERNot place prophylactic drainage after surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinling Hospital
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
weiming zhu
Jinling Hospital, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- the ethics committee of the hospital
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 24, 2019
Study Start
September 6, 2016
Primary Completion
October 25, 2021
Study Completion
December 31, 2022
Last Updated
April 6, 2022
Record last verified: 2022-03