Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Laparoscopic Surgical Procedures
• Interventions: Procedure: Laparoscopic Cholecystectomy (Conventional); Procedure: Laparoscopic Cholecystectomy (Single Incision)

• Registration Number: NCT02417857
• Lead Sponsor: Ankara Mevki Military Hospital

Brief Summary

The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.

Detailed Description

Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p\<0.05 was accepted as statistically significant.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Status Verified: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Last Update Submitted: 2015-04-15
• Study First Posted: 2015-04-16
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• The patients who were scheduled for elective cholecystectomy were included in the study

Exclusion Criteria

• pregnancy
• acute cholecystitis
• ASA 3-4 (American Society of Anesthesiologists)
• history of bile duct stone migration
• biller pancreatitis
• upper laparatomy
• any ventral hernia repair
• chronic systemic disease or
• with allergic attitude to any agent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Cholecystectomy (CLC)	Laparoscopic Cholecystectomy (Conventional)	Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)
Laparoscopic Cholecystectomy (SILC)	Laparoscopic Cholecystectomy (Single Incision)	Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)

Primary Outcome Measures

Name	Time	Method
Quality of life measure	We had performed the questionnaire at postoperative 6 th month

Secondary Outcome Measures

Name	Time	Method
Body Image Questionnaire measure	We had performed the questionnaire at postoperative 6 th month