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NCT06244589 Clinical Trial

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

Cholelithiasis Clinical Trial

Official title:
Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06244589
Other study ID # 16.01.2024-4240
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2024
Est. completion date April 10, 2024

Study information
Verified date February 2024
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact Burak Dincer, M.D.
Phone +905054431566
Email burak-dincer@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1800
Est. completion date April 10, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method
• Open-conversion cholecystectomy
Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.

Locations
Country Name City State
Turkey Sisli Hamidiye Etfal Research and Training Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Open-conversion rate The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases. Immediately after the surgery
Secondary Postoperative complication rate The rate of postoperative complications 1 months after the surgery
Secondary Incidental gallbladder malignancy rate The rate of incidentally diagnosed gallbladder cancer among all laparoscopic cholecystectomies in patients without a preoperative diagnosis. 1 months after the surgery
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