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OpenTrials
Completed

NCT Number: NCT02417857

Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Laparoscopic Surgical Procedures

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Cholecystectomy (Single Incision)

Procedure

We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1

Laparoscopic Cholecystectomy (Conventional)

Procedure

We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2

Primary outcomes

  1. Quality of life measure

    Time frame: We had performed the questionnaire at postoperative 6 th month

Secondary outcomes

  1. Body Image Questionnaire measure

    Time frame: We had performed the questionnaire at postoperative 6 th month

Sponsors and collaborators

Lead sponsor

Ankara Mevki Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 16, 2015
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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