Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery

Not Applicable

• Conditions: Crohn's Disease
• Interventions: Device: no prophylactic drainage; Device: prophylactic drainage

• Registration Number: NCT03815851
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2016-09-06
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-24
• Primary Completion: 2021-10-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-drain group	no prophylactic drainage	Not place prophylactic drainage after surgery.
Drain group	prophylactic drainage	Place prophylactic drainage after surgery.

Primary Outcome Measures

Name	Time	Method
incidence of prolonged postoperative ileus	postoperative 30 days	incidence of prolonged postoperative ileus

Secondary Outcome Measures

Name	Time	Method
recurrence	postoperative 30 days and 1 year after surgery for endoscopic 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.

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China