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

NCT07195643 | Completed

• 1 other identifier: Drainage after cholecystectomy
• Study Type: observational
• Target: 559
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Keywords

Laproscopic cholecystectomy; Drain; Predictive factors

Outcome Measures

Primary Outcomes (1)

• Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion

  Immediately post-op, day zero

Secondary Outcomes (13)

• Operative time

  Day 0 (intraoperative period)

• Incidence of intraoperative bile or stone spillage

  Day 0 (intraoperative period)

• Gallbladder wall thickness

  Baseline (preoperative imaging)

• Presence of adhesions

  Day 0 (intraoperative period)

• Patient demographics

  Baseline (before surgery)

Study Arms (1)

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.

Other: Drain

Interventions

Drain OTHER

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

Patients underwent laparoscopic cholecystectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients who underwent laparoscopic cholecystectomy at Safeer Al-Husain Hospital, Karbala, Iraq. Both male and female patients with gallstone disease (chronic cholecystitis, acute cholecystitis, acute-on-chronic cholecystitis, or biliary colic) were included. This cohort represents a typical Middle Eastern surgical population treated in a tertiary referral hospital, with a wide range of demographic and clinical characteristics.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Safeer Al-Husain Hospital

Karbala, Iraq

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cholecystitis

Interventions

Drainage

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

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

  Iraqi Ministry of Health, Karbala Health Directorate

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, College of Medicine, University of Baghdad

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 26, 2025
• Study Start: January 21, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

IR (1)