Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

NCT ID: NCT02417857

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Laparoscopic Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Cholecystectomy (SILC)

Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)

Group Type: EXPERIMENTAL

Laparoscopic Cholecystectomy (Single Incision)

Intervention Type: PROCEDURE

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

Laparoscopic Cholecystectomy (CLC)

Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)

Group Type: EXPERIMENTAL

Laparoscopic Cholecystectomy (Conventional)

Intervention Type: PROCEDURE

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

Interventions

Laparoscopic Cholecystectomy (Single Incision)

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

Intervention Type: PROCEDURE

Laparoscopic Cholecystectomy (Conventional)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara Mevki Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

MD. Mehmet SAYDAM (General Surgeon)

General Surgeon (M.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huseyin SINAN, Prof. M.D.

Role: STUDY_DIRECTOR

VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY

References

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.

Reference Type: RESULT

PMID: 23269370 (View on PubMed)

Other Identifiers

GMMA-LEC-1648.4-70

Identifier Type: -

Identifier Source: org_study_id