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: Completed

Administrative data

• NCT number: NCT06244589
• Other study ID #: 16.01.2024-4240
• Status: Completed
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: May 28, 2024

Study information

• Verified date: May 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 1695
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 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)

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Cholecystitis, Chronic
• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Diseases
• Gallstones

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