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

Overview

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.

Full Title of Study: “Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI et al) in Crohn’s Patients After Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 25, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: Drain group
    • Place prophylactic drainage after surgery.
  • Other: No-drain group
    • Not place prophylactic drainage after surgery.

Clinical Trial Outcome Measures

Primary Measures

  • incidence of prolonged postoperative ileus
    • Time Frame: postoperative 30 days
    • incidence of prolonged postoperative ileus

Secondary Measures

  • recurrence
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jinling Hospital, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhu Weiming, the ethics committee of the hospital – Jinling Hospital, China
  • Overall Official(s)
    • weiming zhu, Study Chair, Jinling Hospital, China

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