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Open Access Study protocol

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy - a randomised controlled trial

Momin Malik1*, Kirsty McCormack2, Zygmunt H Krukowski1, Alison McDonald2, Gladys McPherson2, Jonathan A Cook2, Irfan Ahmed1 and for the SCARLESS Study Group

Author Affiliations

1 Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN, UK

2 Health Services Research Unit, Health Sciences Building, Foresterhill, University of Aberdeen, Aberdeen, AB25 2ZD, UK

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Trials 2012, 13:201  doi:10.1186/1745-6215-13-201

Published: 30 October 2012

Abstract

Background

Laparoscopic surgery has become the preferred approach for many procedures because of reduced post-operative pain, better recovery, shorter hospital stay and improved cosmesis. Single incision laparoscopic surgery is one of the many recent variants where either standard ports or a specially designed single multi-channel port is introduced through a single skin incision. While the cosmetic advantage of this is obvious, the evidence base for claims of reduced morbidity and better post-operative recovery is weak. This study aims to compare the effectiveness of single port/incision laparoscopic appendicectomy with standard three-port laparoscopic appendicectomy in adult patients at six weeks post-surgery. We also wish to assess the feasibility of a multicentre randomised controlled trial comparing single port/incision laparoscopic surgery with standard three-port laparoscopic surgery for other surgical techniques.

Methods and design

Patients diagnosed with suspected appendicitis and requiring surgical treatment will be randomised to receive either standard three-port or single incision laparoscopic surgery. Data will be collected from clinical notes, operation notes and patient reported questionnaires. The following outcomes will be considered:

1. Effectiveness of the surgical procedure in terms of:

•patient reported outcomes

•clinical outcomes

•resource use

2. Feasibility of conducting a randomised controlled trial (RCT) in the emergency surgical setting by quantifying:

•patient eligibility

•randomisation acceptability

•feasibility of blinding participants to the intervention received

•completion rates of case report forms and patient reported questionnaires

Trial registration

ISRCTN66443895 (assigned 10 March 2011, first patient randomised 09 January 2011)

Keywords:
Appendicitis; Appendicectomy; Laparoscopic; Single port; Single incision; SCARLESS