Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
1 other identifier
interventional
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedApril 16, 2015
April 1, 2015
2.2 years
April 8, 2015
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life measure
We had performed the questionnaire at postoperative 6 th month
Secondary Outcomes (1)
Body Image Questionnaire measure
We had performed the questionnaire at postoperative 6 th month
Study Arms (2)
Laparoscopic Cholecystectomy (SILC)
EXPERIMENTALGroup 1: Single Incision Laparoscopic Cholecystectomy (Intervention)
Laparoscopic Cholecystectomy (CLC)
EXPERIMENTALGroup 2: Conventional Laparoscopic Cholecystectomy (Intervention)
Interventions
We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2
Eligibility Criteria
You may qualify if:
- The patients who were scheduled for elective cholecystectomy were included in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.
PMID: 23269370RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huseyin SINAN, Prof. M.D.
VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Surgeon (M.D.)
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 16, 2015
Study Start
January 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2014
Last Updated
April 16, 2015
Record last verified: 2015-04