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Randomized Controlled Trial Comparative Study
Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy - a randomised controlled trial.
- Momin Malik, Kirsty McCormack, Zygmunt H Krukowski, Alison McDonald, Gladys McPherson, Jonathan A Cook, Irfan Ahmed, and SCARLESS Study Group.
- Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN, UK. momin.malik@nhs.net
- Trials. 2012 Jan 1; 13: 201.
BackgroundLaparoscopic 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 DesignPatients 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 questionnairesTrial RegistrationISRCTN66443895 (assigned 10 March 2011, first patient randomised 09 January 2011).
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