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Completed

NCT Number: NCT07195643

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Safeer Al-Husain Hospital

Karbala, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drain

Other

We want to put a assess the predictive factors for prophylactic drain after cholecystectomy.

Primary outcomes

  1. Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion

    Time frame: Immediately post-op, day zero

Secondary outcomes

  1. Operative time

    Time frame: Day 0 (intraoperative period)

    Duration of laparoscopic cholecystectomy measured in minutes, from first incision to closure

  2. Incidence of intraoperative bile or stone spillage

    Time frame: Day 0 (intraoperative period)

    Documented occurrence of bile leakage or gallstone spillage during the procedure.

  3. Gallbladder wall thickness

    Time frame: Baseline (preoperative imaging)

    Preoperative ultrasound measurement of gallbladder wall thickness and its association with drain placement.

  4. Presence of adhesions

    Time frame: Day 0 (intraoperative period)

    Intraoperative finding of pericholecystic or omental adhesions

  5. Patient demographics

    Time frame: Baseline (before surgery)

    Age, Gender (male/female), Body Mass Index,

  6. Clinical presentation

    Time frame: Baseline (preoperative assessment)

    Acute inflammation, chronic inflammation, biliary colic, acute on chronic inflammation

  7. Trocar insertion technique

    Time frame: Intraoperative

    Easy blind, difficult blind, easy open, difficult open, or Veress needle.

  8. Gallbladder anatomy

    Time frame: Intraoperative

    Classical, adhesions, anomaly

  9. Common bile duct anatomy

    Time frame: Intraoperative

  10. Number of clips used

    Time frame: Intraoperative

  11. Hepatic bed status

    Time frame: Intraoperative

    None, oozing, active bleeding

  12. Gallbladder extraction technique

    Time frame: Intraoperative

    Without manipulation, evacuation of content, wound extension, extension + evacuation, endobag

  13. Other adverse events

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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