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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Port Cholecystectomy | Experimental | Laparoscopic Cholecystectomy with single port transumbilical access |
|
| 4 Port Cholecystectomy | Active Comparator | Laparoscopic Cholecystectomy using 4 separate conventional trocars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Port Cholecystectomy | Device | Using transumbilical single port device: SILS Port |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Breitenstein, PD, MD | Contact | 044 255 33 00 | stefan.breitenstein@usz.ch | |
| Daniel C Steinemann, MD | Contact | 044 255 92 84 | daniel.steinemann@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Breitenstein, PD, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Visceral and Transplantation Surgery | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26583659 | Derived | Lurje G, Raptis DA, Steinemann DC, Amygdalos I, Kambakamba P, Petrowsky H, Lesurtel M, Zehnder A, Wyss R, Clavien PA, Breitenstein S. Cosmesis and Body Image in Patients Undergoing Single-port Versus Conventional Laparoscopic Cholecystectomy: A Multicenter Double-blinded Randomized Controlled Trial (SPOCC-trial). Ann Surg. 2015 Nov;262(5):728-34; discussion 734-5. doi: 10.1097/SLA.0000000000001474. | |
| 21910897 |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| 4 Port Cholecystectomy | Device | using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports |
|
| Derived |
| Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24. |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |