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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis, Acute; Gallbladder Diseases; Cholelithiasis; Cholecystitis, Chronic
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy; Procedure: Open-conversion cholecystectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1695
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Şişli Hamidiye Etfal Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic cholecystectomy; Cases that laparoscopic cholecystectomy performed without need for open-conversion	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method
Experimental: Open-conversion cholecystectomy; Cases converted to open surgery based on intraoperative findings.	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method; Procedure: Open-conversion cholecystectomy; Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open-conversion rate	The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.	Immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complication rate	The rate of postoperative complications	1 months after the surgery
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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Burak Dincer, M.D., Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Conversion; Laparoscopic cholecystectomy; Acute cholecystitis; Cholelithiasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute; Gallstones; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases
• Other Study ID Numbers: 16.01.2024-4240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No