The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy

The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.

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.

Study Overview

• Status: Completed
• Conditions: Drainage; Laparoscopic Cholecystectomy; Acute Cholecystitis
• Intervention / Treatment: Device: Prophylactic Drain

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 Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Aleppo, Syrian Arab Republic
    • Aleppo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with a prophylactic drain after cholecystectomy	Device: Prophylactic Drain; We want to put a prophylactic drain after cholecystectomy.
No Intervention: Patients without using any prophylactic Drainage after cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity /Complications	overall complication rate; graded by the Clavien- Dindo complications classification system.	30 days after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraperitoneal abscess	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	up to 30 days
Wound infection/ Surgical site infection	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).	up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		up to 30 days
Adverse events from the operation		up to 24 hours
Hospital stay	Number of days, patient in hospital since admission	up to 30 days

Collaborators and Investigators

• Sponsor: University of Aleppo

Publications and helpful links

General Publications

• Antoniou S, Koch O, Antoniou G, Kohler G, Chalkiadakis G, Pointner R, Granderath F. Routine versus no drain placement after elective laparoscopic cholecystectomy: meta-analysis of randomized controlled trials. Minerva Chir. 2014 Jun;69(3):185-94.
• Gurusamy KS, Koti R, Davidson BR. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Sep 3;(9):CD006004. doi: 10.1002/14651858.CD006004.pub4.
• Monson JR, Guillou PJ, Keane FB, Tanner WA, Brennan TG. Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial. Surgery. 1991 Jun;109(6):740-6.
• Wong CS, Cousins G, Duddy JC, Walsh SR. Intra-abdominal drainage for laparoscopic cholecystectomy: A systematic review and meta-analysis. Int J Surg. 2015 Nov;23(Pt A):87-96. doi: 10.1016/j.ijsu.2015.09.033. Epub 2015 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cholecystitis; Laparoscopic cholecystectomy; Choledocholithiasis; Acute cholecystitis.; Gallbladder Diseases; Prophylactic Drainage; Upper GI Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: Drainage after cholecystectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will publish the data after publishing the research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No