NCT06244589

Brief Summary

This retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. Patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,695

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

January 29, 2024

Last Update Submit

May 27, 2024

Conditions

CholelithiasisCholecystitis, AcuteCholecystitis, ChronicGallbladder Diseases

Keywords

Laparoscopic cholecystectomyConversionCholelithiasisAcute cholecystitis

Outcome Measures

Primary Outcomes (1)

  • Open-conversion rate

    The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.

    Immediately after the surgery

Secondary Outcomes (2)

  • Postoperative complication rate

    1 months after the surgery

  • Incidental gallbladder malignancy rate

    1 months after the surgery

Study Arms (2)

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Cases that laparoscopic cholecystectomy performed without need for open-conversion

Procedure: Laparoscopic cholecystectomy

Open-conversion cholecystectomy

EXPERIMENTAL

Cases converted to open surgery based on intraoperative findings.

Procedure: Laparoscopic cholecystectomyProcedure: Open-conversion cholecystectomy

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

Laparoscopic cholecystectomyOpen-conversion cholecystectomy
Open-conversion cholecystectomyPROCEDURE

Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.

Open-conversion cholecystectomy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 95 years old.
  • Operated for gallbladder disease (Cholecystectomy)
  • Surgery must started with laparoscopic approach

You may not qualify if:

  • Open surgery from the start
  • Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Dincer B, Omeroglu S, Tufan AE, Uzun MA. Evaluation of Risk Factors Leading to Conversion from Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study. J Laparoendosc Adv Surg Tech A. 2025 Mar;35(3):204-209. doi: 10.1089/lap.2024.0366. Epub 2025 Feb 24.

    PMID: 39992726DERIVED

MeSH Terms

Conditions

CholelithiasisCholecystitis, AcuteCholecystitisBronchiolitis Obliterans SyndromeGallbladder Diseases

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Burak Dincer, M.D.

    Sisli Hamidiye Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study aims to compare cases of laparoscopic cholecystectomy with those undergoing open-conversion cholecystectomy to assess factors influencing the conversion to open surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Burak Dinçer, MD

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

February 12, 2024

Primary Completion

May 28, 2024

Study Completion

May 28, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)