Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
Primary Purpose
Laparoscopic Surgical Procedures
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy (Single Incision)
Laparoscopic Cholecystectomy (Conventional)
Sponsored by
About this trial
This is an interventional treatment trial for Laparoscopic Surgical Procedures focused on measuring Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laparoscopic Cholecystectomy (SILC)
Laparoscopic Cholecystectomy (CLC)
Arm Description
Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)
Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)
Outcomes
Primary Outcome Measures
Quality of life measure
Secondary Outcome Measures
Body Image Questionnaire measure
Full Information
NCT ID
NCT02417857
First Posted
April 8, 2015
Last Updated
April 15, 2015
Sponsor
Ankara Mevki Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02417857
Brief Title
Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
Official Title
Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Mevki Military Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgical Procedures
Keywords
Single İncision Laparoscopic Surgery, Conventional Laparoscopic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Cholecystectomy (SILC)
Arm Type
Experimental
Arm Description
Group 1: Single Incision Laparoscopic Cholecystectomy (Intervention)
Arm Title
Laparoscopic Cholecystectomy (CLC)
Arm Type
Experimental
Arm Description
Group 2: Conventional Laparoscopic Cholecystectomy (Intervention)
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy (Single Incision)
Intervention Description
We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy (Conventional)
Intervention Description
We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2
Primary Outcome Measure Information:
Title
Quality of life measure
Time Frame
We had performed the questionnaire at postoperative 6 th month
Secondary Outcome Measure Information:
Title
Body Image Questionnaire measure
Time Frame
We had performed the questionnaire at postoperative 6 th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin SINAN, Prof. M.D.
Organizational Affiliation
VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23269370
Citation
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.
Results Reference
result
Learn more about this trial
Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
We'll reach out to this number within 24 hrs