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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07195643
Enrollment
559
Registered
2025-09-26
Start date
2024-01-21
Completion date
2025-03-26
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis

Keywords

Laproscopic cholecystectomy, Drain, Predictive factors

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.

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.

Interventions

OTHERDrain

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

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertionImmediately post-op, day zero

Secondary

MeasureTime frameDescription
Incidence of intraoperative bile or stone spillageDay 0 (intraoperative period)Documented occurrence of bile leakage or gallstone spillage during the procedure.
Gallbladder wall thicknessBaseline (preoperative imaging)Preoperative ultrasound measurement of gallbladder wall thickness and its association with drain placement.
Presence of adhesionsDay 0 (intraoperative period)Intraoperative finding of pericholecystic or omental adhesions
Patient demographicsBaseline (before surgery)Age, Gender (male/female), Body Mass Index,
Clinical presentationBaseline (preoperative assessment)Acute inflammation, chronic inflammation, biliary colic, acute on chronic inflammation
Trocar insertion techniqueIntraoperativeEasy blind, difficult blind, easy open, difficult open, or Veress needle.
Operative timeDay 0 (intraoperative period)Duration of laparoscopic cholecystectomy measured in minutes, from first incision to closure
Common bile duct anatomyIntraoperative
Number of clips usedIntraoperative
Hepatic bed statusIntraoperativeNone, oozing, active bleeding
Gallbladder extraction techniqueIntraoperativeWithout manipulation, evacuation of content, wound extension, extension + evacuation, endobag
Other adverse eventsIntraoperative
Gallbladder anatomyIntraoperativeClassical, adhesions, anomaly

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026