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Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition) ›› 2018, Vol. 12 ›› Issue (05): 348-352. doi: 10.3877/cma.j.issn.1674-392X.2018.05.008

Special Issue:

• Original Article • Previous Articles     Next Articles

Prospective randomized controlled clinical trial of domestic absorbable tacks versus imported similar product for mesh fixation in laparoscopic ventral hernia repair

Yiting Liu1, Li Sun1, Jie Chen1,(), Yingmo Shen1   

  1. 1. Department of Hernia and Abdominal Wall, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100043, China
  • Received:2018-02-06 Online:2018-10-18 Published:2018-10-18
  • Contact: Jie Chen
  • About author:
    Corresponding author: Chen Jie, Email:

Abstract:

Objective

To evaluate the safety and effectiveness of a domestic absorbable tack for mesh fixation in laparoscopic ventral hernia repair, compared with a widely used imported similar product.

Methods

From July 2014 to July 2015, a total of 30 patients with kinds of hernias were enrolled in this prospective, single-blind (for subjects), randomized controlled clinical trial. They were divided into 2 groups randomly, 15 cases were received operation by same surgeons with domestic absorbable fixation (experimental group) and 15 cases with imported similar product (control group). Preoperative and postoperative variables, effectiveness of postoperative immediate fixation, fluency and accuracy of instruments and complications were analyzed statistically. Meanwhile, adverse events after operation were recorded and evaluated.

Results

There were no statistically significant differences between the two groups in terms of demographic data, vital signs, preoperative laboratory examination, hernia types, hernia defects, operation methods and fixation methods. One inferior effectiveness of postoperative immediate fixation was in experimental group. Fluency and accuracy of instruments in both groups were comparable. During a follow-up period of 6 months, no recurrence in both groups. No significant differences were noted between the two groups for other complications. There were 6 cases of adverse events and 4 cases of severe adverse events, but "may not be relevant" with the instruments.

Conclusion

It suggests that the domestic absorbable tack in operation for mesh fixation is not inferior to the imported similar product, so it is effective and safe to be worth promoting on clinical application.

Key words: Ventral hernia, Mesh fixation, Comparative study

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