Retrospective Non-Inferiority Analysis of Comparative of Performance on Single Incision Laparoscopic Cholecystectomy (SILC) between Using a Conventional Equipment and a Commercially Available Equipment

Weerayut Thowprasert MD¹, Saritphat Orrapin MD¹

Affiliation : ¹ Department of Surgery, Faculty of Medicine, Thammasat University, Thammasat University Hospital, Pathum Thani, Thailand

Background: Single incision laparoscopic cholecystectomy (SILC) is a modern technique for cholecystectomy via a single transumbilical incision. Original surgical equipment including an articulated minimally invasive surgical instrument was necessary for SILC procedures. However, the articulated long length with flexible rotatable tip instrument is expensive and could not be reimbursed by the Thai National Health Insurance. The present study used conventional laparoscopic equipment that is a non-articulated, shorter, and rigid tip to perform SILC.
Objective: To compare the effectiveness between conventional and original equipment for the SILC procedure by evaluating the difficulty of SILC indicated by the length of operative time.
Materials and Methods: The patients that underwent SILC in Thammasat University Hospital between October 2014 and December 2020 were reviewed from the electronic medical database. The primary outcome was the difficulty of the SILC procedure, determined from the operative time, to evaluate the performance of the SILC procedure between using the conventional or the original equipment in a non-inferiority trial. The secondary outcome was intraoperative and post-operative complications.
Results: The eligibility criteria included 592 SILC procedure that was categorized as conventional equipment group with 351 (59.29%) patients and original equipment group with 241 (40.71%) patients. The multivariate analysis reported the number of difficult SILC procedures was less frequent in SILC using conventional equipment when compared with original equipment, significantly with 37 (10.54%) versus 43 (17.84%) relative risk (RR) (1.75, 95% CI 1.081 to 2.822, p=0.023). The intraoperative bile leakage, cystic artery injury, wound infection and 3-months follow-up of incisional hernia were not different in SILC procedures using eithers equipment.
Conclusion: The application of conventional equipment that is used in multiple-port LC procedure to perform in SILC procedure was safe and not related to difficulty of SILC. This can reduce the cost of surgery, especially for articulated instrument that cannot be reimbursed from the National Health Insurance in Thailand.
Received 6 May 2021 | Revised 16 June 2021 | Accepted 17 June 2021

doi.org/10.35755/jmedassocthai.2021.08.12826

Keywords : Laparoscopic cholecystectomy; Single-incision laparoscopic cholecystectomy; Articulated minimally invasive surgical instrument; Difficult laparoscopic cholecystectomy.

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