Abstract
BACKGROUND AND OBJECTIVE: The aim of this study was to compare the effectiveness of single port/incision laparoscopic surgery (SPILS) with standard three-port laparoscopic surgery for appendicectomy in adults. Feasibility data was collected to evaluate generalizability to other single-port techniques such as cholecystectomy.
METHODS: This was a single-center, randomized controlled trial. Participants were randomized to receive either SPILS or standard three-port laparoscopic appendicectomy. The primary patient-reported outcomes were body image and cosmesis at 6 weeks. The primary clinical outcome was pain at 1-7 days. Secondary outcomes included duration of operation, conversion rates, complication rates, use of analgesia, hospital re-admission rates, re-operation rates, and time to return to normal activities.
RESULTS: Seventy-nine patients were randomized. Sixty-seven completed the day 1-7 diary and 53 completed the 6-week follow-up. SPILS patients answered significantly more favorably to the items in the body image scale [mean (SD) 5.6 (1.0) vs. 7.0 (3.3); -1.4 (95 % CI -2.8 to 1.5; p = 0.03)] and the cosmetic scale [18.9 (4.1) vs. 15.3 (5.8); 3.6 (95 % CI 0.7-6.5; p = 0.016)] compared with patients in the Standard group. The duration of operation was shorter for SPILS, and patients required less morphine in recovery; however, there were no statistically significant differences in other outcomes.
CONCLUSIONS: Patient-reported body image and cosmesis outcomes were better, and surgical outcomes were similar following SPILS. However, the SPILS procedure is more technically demanding and may not be achievable or necessary in routine clinical care. Further assessment of the findings is needed through larger multicenter studies.
| Original language | English |
|---|---|
| Pages (from-to) | 77-85 |
| Number of pages | 9 |
| Journal | Surgical Endoscopy |
| Volume | 29 |
| Issue number | 1 |
| Early online date | 1 Oct 2014 |
| DOIs | |
| Publication status | Published - Jan 2015 |
Bibliographical note
AcknowledgmentsThe authors thank John Norrie for advice regarding the reporting of the study, and clinical staff in the Department of General Surgery, Aberdeen Royal Infirmary, for helping with the conduct of the study. This work was supported by a Grant from the Chief Scientist Office (CSO) of the Scottish Government Health Directorates (Grant Number reference CZG/2/498). Jonathan A. Cook held a Medical Research Council, UK, training fellowship (G0601938) while this research was undertaken. The Health Services Research Unit is funded by the CSO of the Scottish Government Health Directorates. The views expressed in this paper are those of the authors and may not necessarily be shared by the funding bodies. The study was overseen by an Advisory Group comprising Professor Marion Campbell (Director, Health Services Research Unit, Aberdeen), Professor John Norrie (CHaRT Director) and Professor Craig Ramsay (Health Care Assessment Programme Director, Health Services Research Unit, Aberdeen). Professor W. Alastair Chambers was the independent chair of the Trial Steering Committee. Contributing surgeons to the SCARLESS study (in alphabetical order): Bassam Alkari, Emad Aly, Norman Binnie, Duff Bruce, Jan Jansen, Peter King, Tim MacAdam, Aileen McKinley, Terry O’Kelly, Ken Park, Abdul Qadir. The National Health Service provided support through the contribution of the following research nurses: Anu Joyson, Hazel Forbes, and Julie Shotton.
Keywords
- single port/incision laparoscopic surgery
- randomized controlled trial
- appendicectomy
- cosmesis
- pain