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

Primary Purpose

Symptomatic Gallstone Disease

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Single Port Cholecystectomy
4 Port Cholecystectomy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Gallstone Disease focused on measuring cholecystectomy, laparoscopic, single-port, gallstones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients above 18 years of age for elective cholecystectomy
  2. Written informed consent from the subject
  3. INR < 1.4, platelet count > 50'000/mcl

Exclusion Criteria:

  1. Women in pregnancy
  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

Sites / Locations

  • University Hospital Zurich, Division of Visceral and Transplantation SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single Port Cholecystectomy

4 Port Cholecystectomy

Arm Description

Laparoscopic Cholecystectomy with single port transumbilical access

Laparoscopic Cholecystectomy using 4 separate conventional trocars

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Image
validated score. A higher score signifies a better body image.
Pain
Visual Analogue Scale

Full Information

First Posted
January 14, 2011
Last Updated
January 14, 2011
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01278472
Brief Title
Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy
Official Title
Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Gallstone Disease
Keywords
cholecystectomy, laparoscopic, single-port, gallstones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Port Cholecystectomy
Arm Type
Experimental
Arm Description
Laparoscopic Cholecystectomy with single port transumbilical access
Arm Title
4 Port Cholecystectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic Cholecystectomy using 4 separate conventional trocars
Intervention Type
Device
Intervention Name(s)
Single Port Cholecystectomy
Other Intervention Name(s)
SILS PT5, Covidien Inc.
Intervention Description
Using transumbilical single port device: SILS Port
Intervention Type
Device
Intervention Name(s)
4 Port Cholecystectomy
Intervention Description
using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
Primary Outcome Measure Information:
Title
Cosmetic Score
Description
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
Time Frame
6 weeks postoperatively
Secondary Outcome Measure Information:
Title
Body Image
Description
validated score. A higher score signifies a better body image.
Time Frame
6 weeks postoperatively
Title
Pain
Description
Visual Analogue Scale
Time Frame
up to 6 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Breitenstein, PD, MD
Phone
044 255 33 00
Email
stefan.breitenstein@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C Steinemann, MD
Phone
044 255 92 84
Email
daniel.steinemann@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Breitenstein, PD, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Visceral and Transplantation Surgery
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C Steinemann, MD
Phone
044 255 92 84
Email
daniel.steinemann@usz.ch
First Name & Middle Initial & Last Name & Degree
Stefan Breitenstein, PD, MD
First Name & Middle Initial & Last Name & Degree
Daniel C Steinemann, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26583659
Citation
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.
Results Reference
derived
PubMed Identifier
21910897
Citation
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.
Results Reference
derived
Links:
URL
http://www.vis.usz.ch
Description
University Hospital Zurich

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

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