Predictive Factors of Drain Insertion After Laparoscopic Cholecystectomy: A Cohort Study

Completed

• Conditions: Cholecystitis

• Registration Number: NCT07195643
• Lead Sponsor: University of Baghdad

Brief Summary

This study looks at when surgical drains are truly needed after laparoscopic gallbladder removal (laparoscopic cholecystectomy). Drains are sometimes placed during surgery to prevent fluid buildup or infection, but many studies show they are not always necessary. We reviewed 559 patients who had this surgery at Safeer Al-Husain Hospital in Karbala, Iraq. The goal of this study is to help doctors decide more carefully when to use drains, so patients can avoid unnecessary tubes and recover more quickly.

Detailed Description

Background:

Laparoscopic cholecystectomy (LC) is the standard treatment for symptomatic gallstones, offering benefits such as reduced pain, shorter hospital stays, and faster recovery. However, postoperative complications like bile leakage, hemorrhage, and infection remain concerns. Many surgeons use intraoperative drains routinely to prevent these complications, though evidence increasingly suggests selective use may be preferable. Few studies have systematically identified which patient or intraoperative factors predict the need for drain placement.

Objective:

To identify demographic, clinical, and intraoperative predictors of surgical drain placement after LC, enabling evidence-based, selective drain use.

Methods:

* Design: prospective cross-sectional study at Safeer Al-Husain Hospital, Karbala, Iraq.

* Population: 559 patients undergoing LC.

* Data Collection: Patient demographics, operative details, intraoperative findings, and drain usage were extracted from standardized hospital records.

* Statistical Analysis: Associations between patient/surgical variables and drain placement were assessed using univariate and multivariate logistic regression. Statistical significance was defined as p \< 0.05.

Study Timeline

• Study Start: 2024-01-21
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Study First Submitted: 2025-08-20
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 559

Inclusion Criteria

• Underwent laparoscopic cholecystectomy (LC) at Safeer Al-Husain Hospital, Karbala, Iraq.

• Both male and female patients.

• Diagnosed with gallstone disease, including:

  • Chronic cholecystitis
  • Acute cholecystitis
  • Acute-on-chronic cholecystitis
  • Biliary colic

Exclusion Criteria

• Conversion from laparoscopic to open cholecystectomy prior to completion of the procedure.
• Patients undergoing emergency surgery for gallbladder perforation with generalized peritonitis, where standard laparoscopic cholecystectomy was not feasible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion	Immediately post-op, day zero

Secondary Outcome Measures

Name	Time	Method
Operative time	Day 0 (intraoperative period)	Duration of laparoscopic cholecystectomy measured in minutes, from first incision to closure
Trocar insertion technique	Intraoperative	Easy blind, difficult blind, easy open, difficult open, or Veress needle.
Gallbladder anatomy	Intraoperative	Classical, adhesions, anomaly
Common bile duct anatomy	Intraoperative
Number of clips used	Intraoperative
Incidence of intraoperative bile or stone spillage	Day 0 (intraoperative period)	Documented occurrence of bile leakage or gallstone spillage during the procedure.
Gallbladder wall thickness	Baseline (preoperative imaging)	Preoperative ultrasound measurement of gallbladder wall thickness and its association with drain placement.
Presence of adhesions	Day 0 (intraoperative period)	Intraoperative finding of pericholecystic or omental adhesions
Patient demographics	Baseline (before surgery)	Age, Gender (male/female), Body Mass Index,
Clinical presentation	Baseline (preoperative assessment)	Acute inflammation, chronic inflammation, biliary colic, acute on chronic inflammation
Hepatic bed status	Intraoperative	None, oozing, active bleeding
Gallbladder extraction technique	Intraoperative	Without manipulation, evacuation of content, wound extension, extension + evacuation, endobag
Other adverse events	Intraoperative

Trial Locations

Locations (1)

Safeer Al-Husain Hospital; 🇮🇶 Karbala, Iraq