Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

Laparoscopic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417857
• Other study ID #: GMMA-LEC-1648.4-70
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: April 15, 2015
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Ankara Mevki Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Mevki Military Hospital

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measure		We had performed the questionnaire at postoperative 6 th month	Yes
Secondary	Body Image Questionnaire measure		We had performed the questionnaire at postoperative 6 th month	Yes