NDLI: A randomized trial of MONOFIX® vs. V-loc™ for resection bed suture during robotic partial nephrectomy

Content Provider	Springer Nature : BioMed Central
Author	Han, Jang Hee Jung, Gyoohwan Kim, Jung Kwon Byun, Seok-Soo Seo, Seong II Hong, Sung-Hoo Kwak, Cheol Jeong, Chang Wook
Abstract	Background To evaluate the clinical efficacy and safety of Monofix®-PDO compared to V-Loc™ for tumor bed suturing during robotic-assisted laparoscopic partial nephrectomy (RAPN). Methods A randomized, controlled, multicenter, single-blinded trial was conducted across four tertiary institutions. Patients with T1-2 stage renal masses scheduled for RAPN were enrolled. The exclusion criteria included patients not deemed in need of bed suturing, those with a history of prior chemotherapy or immunotherapy, and those with severe systemic diseases or high bleeding tendencies. A total of 174 patients participated and were subjected to permuted block randomization (T1a vs. others), resulting in 88 patients in the V-Loc™ group and 86 in the Monofix®-PDO group. The primary outcome was the resection bed suture time. The secondary outcomes were total suture use time, warm ischemia time, console time (for efficacy), estimated blood loss, hemoglobin change, and 90-day treatment-related adverse events (for safety). All patients were scheduled for follow-up visits for up to three months postoperatively. Results The primary outcome, resection bed suture time, did not significantly differ between the V-Loc™ and Monofix®-PDO groups (4.8 ± 2.6 vs. 4.5 ± 2.6 min, p = 0.531). Secondary outcomes, including total suture used time (5.3 ± 2.8 vs. 4.8 ± 2.6 min, p = 0.289) and warm ischemic time (15.6 ± 5.5 vs. 15.4 ± 5.4 min, p = 0.834), were comparable between the two groups. In terms of safety outcomes, changes in serum hemoglobin levels did not show significant differences on postoperative days 1, 3, and 14 (P = 0.537, 0.353, and 0.840, respectively). No device-related adverse events were observed during the 90-day follow-up period in either group. Conclusions Monofix®-PDO demonstrated non-inferior to V-Loc in terms of both safety and efficacy in patients undergoing RAPN. This trial is registered on cris.nih.go.kr as KCT0006809 (Registration date: 02/19/2021).
Related Links	https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-024-13213-6.pdf
Ending Page	7
Page Count	7
Starting Page	1
File Format	HTM / HTML
ISSN	14712407
DOI	10.1186/s12885-024-13213-6
Journal	BMC Cancer
Issue Number	1
Volume Number	24
Language	English
Publisher	BioMed Central
Publisher Date	2024-11-27
Access Restriction	Open
Subject Keyword	Cancer Research Oncology Surgical Oncology Health Promotion and Disease Prevention Biomedicine Medicine Public Health Barbed suture Partial nephrectomy Bed suture time Monofix V-Loc Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology Genetics
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	3.8/2023

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