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Single-Incision Versus Conventional Laparoscopic Appendectomy: A Multi-Center Randomized Controlled Trial (SCAR trial)

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Author(s)
Sung Il KangIn Teak WooSung Uk BaeChun-Seok Yang
Keimyung Author(s)
Bae, Sung Uk
Department
Dept. of Surgery (외과학)
Journal Title
Int J Surg Protoc
Issued Date
2021
Volume
21
Issue
1
Keyword
appendicitissingle-incision laparoscopic appendectomyconventional laparoscopic appendectomy
Abstract
Introduction:
Although single-incision laparoscopic appendectomy (SILA) was introduced decades ago, it is still considered a difficult technique to perform compared to conventional laparoscopic appendectomy (CLA). In addition, controversy about the benefits of SILA compared to CLA abound and no definite criteria for choosing SILA over CLA in patients with appendicitis currently exist. Therefore, we have planned a multicenter randomized controlled trial to compare SILA with CLA in terms of cosmetic satisfaction and pain reduction.

Methods and analysis:
Patients diagnosed with appendicitis at the participating centers will be recruited and allocated into either a CLA or an SILA groups using a 1:1 randomization. Patients in the CLA group will receive a conventional 3-port laparoscopic appendectomy and patients in the SILA group will receive a laparoscopic appendectomy using a single-incision at the umbilicus. The primary trial endpoint is cosmetic satisfaction assessed using the Patients and Observer Scar Assessment Scale (POSAS) administered 6 weeks post-surgery. Secondary trial endpoints include cosmetic satisfaction assessed via the Body Image Questionnaire, pain levels assessed via the Visual Analog Scale and International Pain Outcomes questionnaire, and the presence of postoperative complications. The target sample size of this superiority trial is 120 patients, as this will provide 80% power at the 2.5% level of significance to detect a 3-point difference in POSAS.

Discussion:
The results of this planned multi-center randomized controlled trial will provide substantive evidence to help surgeons choose when to use SILA over CLA in patients with appendicitis.

Ethics and dissemination:
This trial was approved by the institutional review board at Daegu joint on February 27, 2020 (No: 19-12-001-001) and registered with the clinical research information service (CRIS) (KCT0005048). The results of the study will be published and presented at appropriate conferences.
Keimyung Author(s)(Kor)
배성욱
Publisher
School of Medicine (의과대학)
Citation
Sung Il Kang et al. (2021). Single-Incision Versus Conventional Laparoscopic Appendectomy: A Multi-Center Randomized Controlled Trial (SCAR trial). Int J Surg Protoc, 21(1), 201–208. doi: 10.29337/ijsp.159
Type
Article
ISSN
2468-3574
Source
https://www.ijsprotocols.com/articles/10.29337/ijsp.159/
DOI
10.29337/ijsp.159
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43956
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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