- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417857
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
Status
Completed
Conditions
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.
Sponsor
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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