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

NCT07195643 — Completed, 559 participants, University of Baghdad

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT07195643
StatusCompleted
Study typeObservational
Enrollment559 (Actual)
SponsorUniversity of Baghdad (Other)
ConditionsCholecystitis
InterventionsDrain (Other)
Datesstart 2024-01-21, primary completion 2025-03-26, completion 2025-03-26, first posted 2025-09-26, last updated 2025-09-26
Locations1 site in Iraq

Related Papers Related Patents Related Grants Related Experts
All trials for Cholecystitis All trials of Drain

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients underwent laparoscopic cholecystectomyOther: DrainThis study cohort consists of 559 patients who underwent laparoscopic cholecystectomy (LC) at Safeer Al-Husain Hospital, Karbala, Iraq, between January 2025 and March 2025. Patients were included regardless of age, gender, body mass index, or gallbladder pathology, as long as they underwent elective or emergency LC.
  • Drain (Other): We want to put a assess the predictive factors for prophylactic drain after cholecystectomy.

+Outcome measures

Primary outcomes

  • Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion [Immediately post-op, day zero]

Secondary outcomes

  • Operative time [Day 0 (intraoperative period)]: Duration of laparoscopic cholecystectomy measured in minutes, from first incision to closure
  • 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
  • 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]
  • 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]

+Eligibility

Sex: All

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.

+Locations (1)

FacilityCityCountryStatus
Safeer Al-Husain HospitalKarbalaIraq

+Publications

  • Zhu H, Liu D, Zhou D, Wu J, Yu Y, Jin Y, Ye D, Ding C, Zhang X, Huang B, Peng S, Li J. Effectiveness of no drainage after elective day-case laparoscopic cholecystectomy, even with intraoperative gallbladder perforation: a randomized controlled trial. Langenbecks Arch Surg. 2023 Mar 1;408(1):112. doi: 10.1007/s00423-023-02846-z. PMID 36856748
  • Xu M, Tao YL. Drainage versus No Drainage after Laparoscopic Cholecystectomy for Acute Cholecystitis: A Meta-Analysis. Am Surg. 2019 Jan 1;85(1):86-91. PMID 30760351
  • Bawahab MA, Abd El Maksoud WM, Alsareii SA, Al Amri FS, Ali HF, Nimeri AR, Al Amri AR, Assiri AA, Abdul Aziz MI. Drainage vs. non-drainage after cholecystectomy for acute cholecystitis: a retrospective study. J Biomed Res. 2014 May;28(3):240-5. doi: 10.7555/JBR.28.20130095. Epub 2014 Apr 10. PMID 25013408
  • Calini G, Brollo PP, Quattrin R, Bresadola V. Predictive Factors for Drain Placement After Laparoscopic Cholecystectomy. Front Surg. 2022 Feb 2;8:786158. doi: 10.3389/fsurg.2021.786158. eCollection 2021. PMID 35187046

+Investigators