The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy; Drainage; Acute Cholecystitis
• Interventions: Device: Prophylactic Drain

• Registration Number: NCT05267860
• Lead Sponsor: University of Aleppo

Brief Summary

Investigators want to assess the safety and efficacy of using abdominal drainage with not using any drainage, by estimating different outcomes after laparoscopic cholecystectomy for different reasons. Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.

Detailed Description

The routine use of prophylactic drainage has become common in many hospitals around the world after cholecystectomy for different reasons. In elective surgeries, the evidence does not support the use of drainage. But in emergency laparoscopic cholecystectomy surgeries, using drainage remains controversial. Surgeons who support the use of drainage find it useful to identify the early complications of surgery and removing intra-abdominal collections, while opponents of drainage use believe that it increases the risk of wound infection. But, a systematic review and meta-analysis discussed the ineffectiveness of the routine use of the prophylactic drainage after laparoscopic cholecystectomy for acute cholecystitis and requested more randomized clinical trial studies on the subject. However, this study and others in the medical literature contain very few high-quality randomized controlled trials, hence our randomized controlled trial compares the use and non-use of drainage in patients undergoing laparoscopic cholecystectomy for different reasons.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-04
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.
• Patients who undergo cholecystectomy for any reason.

Exclusion Criteria

• Non-cooperative patients for regular follow up.
• Draining for therapeutic indications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with a prophylactic drain after cholecystectomy	Prophylactic Drain	-

Primary Outcome Measures

Name	Time	Method
Morbidity /Complications	30 days after the operation	overall complication rate; graded by the Clavien- Dindo complications classification system.

Secondary Outcome Measures

Name	Time	Method
Intraperitoneal abscess	up to 30 days	The patient will be monitored and followed up for 30 days after the surgery, and the necessary investigations will be requested to diagnose if the patient has an Intraperitoneal abscess
Wound infection/ Surgical site infection	up to 30 days	Surgical site infection has been defined and classified as superficial incisional, deep incisional, and organ/ space_ surgical site infection by the Centers for Disease Control and Prevention (CDC) (Anderson 2014; Ban 2017; Berríos-Torres 2017).

Trial Locations

Locations (1)

Aleppo University Hospital; 🇸🇾 Aleppo, Syrian Arab Republic