Midwest Surgical AssociationProspective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: Report of preliminary data
Section snippets
Methods
A total of 9 investigational sites were used to recruit patients into the clinical study, with each site expected to recruit between 22 and 25 participants. Informed consent was obtained from the patients, and approval was obtained from the designated review board of the institution involved. The sample size target for the complete study is 200 patients to evaluate for the primary endpoint (safety). Patients were randomized in a 1.5:1 ratio so that 120 were randomized to SILC and 80 to 4PLC.
Procedure
After the delivery of general endotracheal anesthesia, the abdomen was prepped and draped sterilely with careful attention to the cleaning of the umbilicus. At this time, the study envelope was opened, and the procedure was continued according to the randomization card.
SILC surgical technique
The umbilicus was grasped at its base and everted. A skin incision was made within the umbilical fold, and an approximately 20-mm fascial incision was created. The SILS port was then placed into the peritoneal cavity with the assistance of a curved clamp.
Cholecystectomy with or without cholangiogram was then performed in accordance with the standard of care and the judgment of the surgeon. Curved or articulating instruments were used at the discretion of the operating surgeon. Five cubic
PLC surgical technique
4PLC was performed using 2- or 3-mm ports and one 10-mm or 12-mm port placed at the discretion of the surgeon. Multiport laparoscopic cholecystectomy with or without cholangiogram was then performed in accordance with the standard of care and the judgment of the surgeon. Again, 5 mL of 1% Marcaine was injected into the skin around each incision at the conclusion of the procedure, and SteriStrips were placed. Conversion to laparotomy or the placement of any additional ports was performed at the
Statistics
For both intraoperative and postoperative adverse events, data were compared between the 2 procedures using the Fisher exact tests. Because of the skewed data distribution, operative time and the estimated blood loss were summarized as the median and range for each procedure and compared using nonparametric tests and the Wilcoxon rank sum test. The Pain Intensity Numerical Rating Scale, Photo Series Questionnaire, Body Image Questionnaire, SF-8, SF-12, and port insertion time were analyzed
Results
In this preliminary review of data, 83 total patients (SILC, n = 50; 4PLC, n = 33) were enrolled with a follow-up of 1 week (n = 76), 2 weeks (n = 72), 4 weeks (n = 65), and 3 months (n = 31) available for evaluation. Age, sex, body mass index, and time to canalization (completion of cannula placement) were statistically similar (Table 2). Total operative times were significantly longer for SILC versus 4PLC (53.2 vs 42.0, P = .003) (Table 3). One SILC case was converted to 4PLC. Adverse events
Comments
This was an unplanned preliminary analysis of a continuing clinical trial to establish the safety of SILS as an operative approach to gallbladder disease. This article presents preliminary data (40% of total enrollment, with 37% of these available for a 3-month follow-up evaluation) of a multicenter, prospective randomized, single-blinded study comparing single-incision cholecystectomy with standard multiport laparoscopic cholecystectomy. Primary endpoints included feasibility and safety, with
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2019, Surgery (United States)Citation Excerpt :In particular, QOL is drawing attention as a key measure to understand how patients evaluate their physical, mental, or social health status.21 So far, several studies have consistently reported greater cosmetic satisfaction with SILC over 4PLC.7-10 In contrast, controversy persists regarding pain; some studies have reported that SILC has an advantage regarding pain because of the decreased number of ports,5,7,10,16 whereas other studies have reported that an unfavorable pain profile resulted from the larger umbilical incision required for SILC.8,14
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