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OpenTrials
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NCT Number: NCT06244589

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method

Open-conversion cholecystectomy

Procedure

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

Primary outcomes

  1. Open-conversion rate

    Time frame: Immediately after the surgery

    The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.

Secondary outcomes

  1. Postoperative complication rate

    Time frame: 1 months after the surgery

    The rate of postoperative complications

  2. Incidental gallbladder malignancy rate

    Time frame: 1 months after the surgery

    The rate of incidentally diagnosed gallbladder cancer among all laparoscopic cholecystectomies in patients without a preoperative diagnosis.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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