NCT01534780

3 Fixation Devices in Laparoscopic Ventral Herniotomy

A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Horsens Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh. Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.

Detailed description

see brief summary

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
PROCEDURE	laparoscopic ventral herniotomy	Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
DEVICE	Protack	fixation of mesh with protack
DEVICE	Securestrap	fixation of mesh with Securestrap
DEVICE	Glubran	fixation of mesh with Glubran

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2012-02-17
• Last updated: 2020-02-19

Locations

1 site across 1 country: Denmark