Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

Overview

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.

Full Title of Study: “Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • Procedure: Laparoscopic Cholecystectomy (Single Incision)
    • We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
  • Procedure: Laparoscopic Cholecystectomy (Conventional)
    • We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life measure
    • Time Frame: We had performed the questionnaire at postoperative 6 th month

Secondary Measures

  • Body Image Questionnaire measure
    • Time Frame: We had performed the questionnaire at postoperative 6 th month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ankara Mevki Military Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: MD. Mehmet SAYDAM (General Surgeon), General Surgeon (M.D.) – Ankara Mevki Military Hospital
  • Overall Official(s)
    • Huseyin SINAN, Prof. M.D., Study Director, VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY

Citations Reporting on Results

Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.

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