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

NCT ID: NCT07195643

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-21

Study Completion Date

2025-03-26

Brief Summary

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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

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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.

Conditions

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Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients underwent laparoscopic cholecystectomy

This 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

Intervention Type OTHER

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

Interventions

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Drain

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Mohammedsadeq A. Shweliya

Principal Investigator, College of Medicine, University of Baghdad

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arkan Shubber AbdulKhaliq Al-hamdany, F.I.B.M.S.

Role: STUDY_DIRECTOR

Iraqi Ministry of Health, Karbala Health Directorate

Locations

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Safeer Al-Husain Hospital

Karbala, , Iraq

Site Status

Countries

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Iraq

References

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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.

Reference Type BACKGROUND
PMID: 36856748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30760351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25013408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35187046 (View on PubMed)

Other Identifiers

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Drainage after cholecystectomy

Identifier Type: -

Identifier Source: org_study_id

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