Gallbladder Disease Clinical Trial
Official title:
The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively
Single-incision laparoscopic procedures have evolved gradually to include a multitude of
various surgeries. The current literature documents the use of a single-incision or
single-port access surgery for cholecystectomies, adrenalectomies, splenectomies,
appendectomies, herniorrhaphies, bariatrics, and colon surgery.
Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders
will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy
group (n= 50) according to a computer-generated table of random numbers. Demographics (ie,
age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score,
indication for operation, need for conversion to a standard or three port laparoscopic
cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome
measures include operative morbidity, operative time, pain score, hospital stay. Morbidity
will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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