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

Crohn's Disease Clinical Trial

— RBPD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03815851
• Other study ID #: jinlingH201608
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Postoperative Complications

Intervention

Device:
• prophylactic drainage
place prophylactic drainage after surgery
• no prophylactic drainage
Not place prophylactic drainage after surgery

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of prolonged postoperative ileus	incidence of prolonged postoperative ileus	postoperative 30 days
Secondary	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.	postoperative 30 days and 1 year after surgery for endoscopic recurrence.