A Prospective, Single-blind, Randomized, Multi Centre, Study to Assess the Clinical Equivalence of Trutie® Ligating Clips to Ligaclip® Ligating Clips in Laparoscopic Cholecystectomy
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Abstract
Introduction: Laparoscopic cholecystectomy, the gold standard for treating gallbladder diseases, requires reliable closure of the cystic duct and artery, typically using titanium ligating clips. This study aims to assess the clinical equivalence of Trutie® ligating clips compared to Ligaclip® ligating clips. Methods: A prospective, single-blind, randomized, multicenter study was carried out from May 2023 to April 2024 which included male and female subjects aged 18 to 60 years scheduled for elective laparoscopic cholecystectomy and were randomized to Trutie® Ligating clips (n=64) and Ligaclip® Ligating clips (n=62). Primary endpoints included the incidence of bile leakage and bleeding. Secondary endpoints assessed postoperative recovery, intraoperative handling of clips and clip applicator, number of clip breakage, failure to ligate, malformed/deformed clips, incidence of residual risks of ligating clips, quality of life, and adverse events. Results: There was no incidence of bile leakage and bleeding. Intraoperative and postoperative outcomes showed no significant differences. Quality of life improvements over six months were comparable between the two groups. No serious adverse events were reported. Conclusion: Trutie® ligating clips are clinically equivalent to Ligaclip® ligating clips in laparoscopic cholecystectomy.
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Copyright (c) 2025 Sanjay Kala, Seraj Ahmed, Prashant V Rahate, Srikant Kulkarni, Ramendra Kumar Jauhari, Anurag Singh, Abhishek Kumar Gond, Nabarun Manna, Ashok Kumar Moharana, Deepak TS
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