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

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 use2. 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).