Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

April 15, 2015 updated by: MD. Mehmet SAYDAM (General Surgeon), Ankara Mevki Military Hospital

Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Cholecystectomy (SILC)
Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)
We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
Experimental: Laparoscopic Cholecystectomy (CLC)
Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)
We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Huseyin SINAN, Prof. M.D., VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMMA-LEC-1648.4-70

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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