Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery

NCT ID: NCT06244589

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1695 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-05-28

Brief Summary

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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.

Detailed Description

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Cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. Despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. Although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. This study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy.

The study will be conducted retrospectively by reviewing archive records. Patients operated for cholecystectomy will be included. Patients that open surgical method used from start will be excluded from study. Age, comorbidities (ASA score), laboratory findings (leukocyte count and CRP), imaging findings (abdominal ultrasound, CT, or MRI), history of previous abdominal surgery, history of ERCP, and history of pancreatitis will be evaluated. Laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.

Conditions

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Cholelithiasis Cholecystitis, Acute Cholecystitis, Chronic Gallbladder Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study aims to compare cases of laparoscopic cholecystectomy with those undergoing open-conversion cholecystectomy to assess factors influencing the conversion to open surgery.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic cholecystectomy

Cases that laparoscopic cholecystectomy performed without need for open-conversion

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

Open-conversion cholecystectomy

Cases converted to open surgery based on intraoperative findings.

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

Open-conversion cholecystectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic cholecystectomy

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

Intervention Type PROCEDURE

Open-conversion cholecystectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Open surgery from the start
* Cholecystectomy as a part of bigger surgical intervention (Such as pancreaticoduodenectomy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Burak Dincer

Burak Dinçer, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burak Dincer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sisli Hamidiye Etfal Training and Research Hospital

Locations

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Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39992726 (View on PubMed)

Other Identifiers

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16.01.2024-4240

Identifier Type: -

Identifier Source: org_study_id

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