Predictive Factors of Drain Insertion After Laparoscopic Cholecystectomy: A Cohort Study
NCT ID: NCT07195643
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
559 participants
OBSERVATIONAL
2024-01-21
2025-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
NCT01625247
Effects of Drainage in Laparoscopic Cholecystectomy
NCT02027402
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy
NCT05267860
Drain After Elective Laparoscopic Cholecystectomy
NCT00986544
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
NCT04134546
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
We want to put a assess the predictive factors for prophylactic drain after cholecystectomy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drain
We want to put a assess the predictive factors for prophylactic drain after cholecystectomy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Both male and female patients.
* Diagnosed with gallstone disease, including:
* Chronic cholecystitis
* Acute cholecystitis
* Acute-on-chronic cholecystitis
* Biliary colic
Exclusion Criteria
* Patients undergoing emergency surgery for gallbladder perforation with generalized peritonitis, where standard laparoscopic cholecystectomy was not feasible.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Baghdad
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammedsadeq A. Shweliya
Principal Investigator, College of Medicine, University of Baghdad
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arkan Shubber AbdulKhaliq Al-hamdany, F.I.B.M.S.
Role: STUDY_DIRECTOR
Iraqi Ministry of Health, Karbala Health Directorate
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Safeer Al-Husain Hospital
Karbala, , Iraq
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Drainage after cholecystectomy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.