Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery. The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency. Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints. This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.

Official Title
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Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial

Conditions
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Symptomatic Gallstone Disease

Intervention / Treatment
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* Device: Single Port Cholecystectomy
* Device: 4 Port Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above 18 years of age for elective cholecystectomy Written informed consent from the subject INR < 1.4, platelet count > 50'000/mcl Exclusion Criteria: Women in pregnancy Contraindications on ethical grounds Severe coagulopathy (platelet < 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR > 1.4 liver cirrhosis Enrolment of the investigator, his/her family members, employees and other dependent persons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Port Cholecystectomy<br>Laparoscopic Cholecystectomy with single port transumbilical access | Device: Single Port Cholecystectomy<br>* Using transumbilical single port device: SILS Port<br>* Other names: SILS PT5, Covidien Inc.;|
| Active Comparator: 4 Port Cholecystectomy<br>Laparoscopic Cholecystectomy using 4 separate conventional trocars | Device: 4 Port Cholecystectomy<br>* using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Score | validated score where the minimum is 3 and the maximum 24 points. A higher score signifies a greater satisfaction of the physical appearance of the scar | 6 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Image | validated score. A higher score signifies a better body image. | 6 weeks postoperatively | 
| Pain | Visual Analogue Scale | up to 6 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy, laparoscopic, single-port, gallstones