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CholecystitisNCT07195643

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

An observational study of Cholecystitis, run by University of Baghdad at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cholecystitis
What is being tested?
Drain
How many people
559 participants
Where
1 siteIraq
Study dates
21 Jan 2024to 26 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Iraq1 site

  • Safeer Al-Husain Hospital

    Karbala

Other trials in Iraq

About this study

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.

Read the 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.
Conditions
Cholecystitis
Being tested
Drain
Keywords
Laproscopic cholecystectomy, Drain, Predictive factors
Medical subject headings
Cholecystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DrainOther

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

Study groups in NCT07195643
Study groupRoleWhat they receive
Patients underwent laparoscopic cholecystectomyThis 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.
Receives: Other: Drain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion

    Measured: Immediately post-op, day zero

Secondary outcomes (13)

  1. Operative time

    Duration of laparoscopic cholecystectomy measured in minutes, from first incision to closure

    Measured: Day 0 (intraoperative period)

  2. Incidence of intraoperative bile or stone spillage

    Documented occurrence of bile leakage or gallstone spillage during the procedure.

    Measured: Day 0 (intraoperative period)

  3. Gallbladder wall thickness

    Preoperative ultrasound measurement of gallbladder wall thickness and its association with drain placement.

    Measured: Baseline (preoperative imaging)

  4. Presence of adhesions

    Intraoperative finding of pericholecystic or omental adhesions

    Measured: Day 0 (intraoperative period)

  5. Patient demographics

    Age, Gender (male/female), Body Mass Index,

    Measured: Baseline (before surgery)

  6. Clinical presentation

    Acute inflammation, chronic inflammation, biliary colic, acute on chronic inflammation

    Measured: Baseline (preoperative assessment)

  7. Trocar insertion technique

    Easy blind, difficult blind, easy open, difficult open, or Veress needle.

    Measured: Intraoperative

  8. Gallbladder anatomy

    Classical, adhesions, anomaly

    Measured: Intraoperative

  9. Common bile duct anatomy

    Measured: Intraoperative

  10. Number of clips used

    Measured: Intraoperative

  11. Hepatic bed status

    None, oozing, active bleeding

    Measured: Intraoperative

  12. Gallbladder extraction technique

    Without manipulation, evacuation of content, wound extension, extension + evacuation, endobag

    Measured: Intraoperative

  13. Other adverse events

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start21 Jan 2024
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195643
Sponsor's protocol ID
Drainage after cholecystectomy
Status last verified
Sep 2025
First submitted
20 Aug 2025
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35187046

Questions about this trial

What is this clinical trial studying?

An observational study of Cholecystitis, run by University of Baghdad at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients undergoing laparoscopic cholecystectomy who require intraoperative drain insertion (time frame: Immediately post-op, day zero). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07195643, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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