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

NCT01278472 | Unknown DMC

• 1 other identifier: 2010-0321/4
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Gallstone Disease

Keywords

cholecystectomy; laparoscopic; single-port; gallstones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body Image

  6 weeks postoperatively

• Pain

  up to 6 weeks postoperatively

Study Arms (2)

Single Port Cholecystectomy

EXPERIMENTAL

Laparoscopic Cholecystectomy with single port transumbilical access

Device: Single Port Cholecystectomy

4 Port Cholecystectomy

ACTIVE COMPARATOR

Laparoscopic Cholecystectomy using 4 separate conventional trocars

Device: 4 Port Cholecystectomy

Interventions

Single Port Cholecystectomy DEVICE

Using transumbilical single port device: SILS Port

Also known as: SILS PT5, Covidien Inc.

Single Port Cholecystectomy

4 Port Cholecystectomy DEVICE

using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports

4 Port Cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Visceral and Transplantation Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 26583659 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.

  PMID: 21910897 DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Breitenstein, PD, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 17, 2011

Record last verified: 2011-01

Locations

CH (1)