Clinical trial NCT01278472: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Gallstone Disease
Keywords: cholecystectomy
laparoscopic
single-port
gallstones
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cosmetic Score
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: Body Image
timeFrame: 6 weeks postoperatively
measure: Pain
timeFrame: up to 6 weeks postoperatively
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Visceral and Transplantation Surgery
Study officials:
affiliation: University of Zurich
name: Stefan Breitenstein, PD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.