An interventional study of Laparoscopic cholecystectomy and Open-conversion cholecystectomy in Cholelithiasis, Cholecystitis, Acute and Cholecystitis, Chronic, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's enrollment of 1,695 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Cases that laparoscopic cholecystectomy performed without need for open-conversion
Procedure: Laparoscopic cholecystectomy
Cases converted to open surgery based on intraoperative findings.
Procedure: Laparoscopic cholecystectomy · Procedure: Open-conversion cholecystectomy
Laparoscopic cholecystectomy: Cholecystectomy that performed with laparoscopic method
Open-conversion cholecystectomy: Cases in which laparotomy (Generally right subcostal incision) was performed based on intraoperative findings.
Open-conversion rate
The rate of cases converted to open surgery among all laparoscopic cholecystectomy cases.
Time frame: Immediately after the surgery
Postoperative complication rate
The rate of postoperative complications
Time frame: 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.
Time frame: 1 months after the surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in May 2024, 3 months.
Of 54 non-industry interventional studies with no phase under Cholelithiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 3 months is below that.
Counting every sponsor, half of 58 studies reached it within 15 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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