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

Sisli Hamidiye Etfal Training and Research Hospital

Status: Completed

Conditions: Gallbladder Diseases; Cholecystitis, Acute; Cholelithiasis; Cholecystitis, Chronic

Treatments: Procedure: Laparoscopic cholecystectomy; Procedure: Open-conversion cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06244589

16.01.2024-4240

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,695 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,695 participants in 2 patient groups

Laparoscopic cholecystectomy

Active Comparator group

Description:

Cases that laparoscopic cholecystectomy performed without need for open-conversion

Treatment:

Procedure: Laparoscopic cholecystectomy

Open-conversion cholecystectomy

Experimental group

Description:

Cases converted to open surgery based on intraoperative findings.

Treatment:

Procedure: Open-conversion cholecystectomy

Procedure: Laparoscopic cholecystectomy