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Open Access Study protocol

Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial)

Daniel C Steinemann1*, Dimitri A Raptis1, Georg Lurje1, Christian E Oberkofler1, Roland Wyss2, Adrian Zehnder2, Mickael Lesurtel1, René Vonlanthen1, Pierre-Alain Clavien1 and Stefan Breitenstein1*

Author Affiliations

1 Department of Surgery, Division of Visceral and Transplantation Surgery, University Hospital Zurich, 8091 Zurich, Switzerland

2 Department of Surgery, Cantonal Hospital Winterthur, 8401 Winterthur, Switzerland

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BMC Surgery 2011, 11:24  doi:10.1186/1471-2482-11-24

Published: 12 September 2011

Abstract

Background

Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated.

Methods/Design

The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.

Discussion

The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.

Trial registration

(clinicaltrial.gov): NCT 01278472