Clinical trial NCT06244589: Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery
Official title: Evaluation of Risk Factors Leading to Conversion From Laparoscopic Cholecystectomy to Open Surgery: A Retrospective Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Cholecystitis, Acute
Cholecystitis, Chronic
Gallbladder Diseases
Keywords: Laparoscopic cholecystectomy
Conversion
Cholelithiasis
Acute cholecystitis
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 1695
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Open-conversion rate
timeFrame: Immediately after the surgery
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: 1 months after the surgery
measure: Incidental gallbladder malignancy rate
timeFrame: 1 months after the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Research and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Burak Dincer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: