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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06244589
Enrollment
1695
Registered
2024-02-06
Start date
2024-02-12
Completion date
2024-05-28
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Acute, Cholecystitis, Chronic, Cholelithiasis, Gallbladder Diseases

Keywords

Laparoscopic cholecystectomy, Conversion, Cholelithiasis, Acute cholecystitis

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.

Interventions

PROCEDURELaparoscopic cholecystectomy

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

PROCEDUREOpen-conversion cholecystectomy

Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Open-conversion rateImmediately after the surgeryThe rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.

Secondary

MeasureTime frameDescription
Postoperative complication rate1 months after the surgeryThe rate of postoperative complications
Incidental gallbladder malignancy rate1 months after the surgeryThe rate of incidentally diagnosed gallbladder cancer among all laparoscopic cholecystectomies in patients without a preoperative diagnosis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026