Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy
NCT ID: NCT01278472
Last Updated: 2011-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2011-01-31
2012-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Single Port Cholecystectomy
Laparoscopic Cholecystectomy with single port transumbilical access
Single Port Cholecystectomy
Using transumbilical single port device: SILS Port
4 Port Cholecystectomy
Laparoscopic Cholecystectomy using 4 separate conventional trocars
4 Port Cholecystectomy
using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
Interventions
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Single Port Cholecystectomy
Using transumbilical single port device: SILS Port
4 Port Cholecystectomy
using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent from the subject
3. INR \< 1.4, platelet count \> 50'000/mcl
Exclusion Criteria
2. Contraindications on ethical grounds
3. Severe coagulopathy (platelet \< 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR \> 1.4
4. liver cirrhosis
5. Enrolment of the investigator, his/her family members, employees and other dependent persons
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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University Hospital Zurich, Division of Visceral and Transplantation Surgery
Principal Investigators
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Stefan Breitenstein, PD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich, Division of Visceral and Transplantation Surgery
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2010-0321/4
Identifier Type: -
Identifier Source: org_study_id
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