The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Gallbladder Disease
• Interventions: Procedure: SILS cholecystectomy; Procedure: TPCL cholecystectomy

• Registration Number: NCT01772745
• Lead Sponsor: Maltepe University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Study First Posted: 2013-01-21
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria

• American Society of Anesthesiologists score (ASA) more than III,
• Patients had prior abdominal surgery,
• Patients admitted outside working hours with acute cholecystitis,
• Patients have choledocolithiasis,
• pregnancy,
• ongoing peritoneal dialysis,
• lack of written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	SILS cholecystectomy	SILS cholecystectomy
Group 2	TPCL cholecystectomy	TPCL cholecystectomy

Primary Outcome Measures

Name	Time	Method
pain score	Postoperative first 24 hours	Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
Intraoperative complications	Average of 70 minutes	Per operative complications will be recorded.; * Bleeding; * Gallbladder perforation; * Bile leakage; * Bowel perforation; * Complications associated with increased intra-abdominal pressure

Secondary Outcome Measures

Name	Time	Method
Operating time	Average of 70 minutes	The operating time will be defined as the time from the first incision to the last suture's placement.