3 Fixation Devices in Laparoscopic Ventral Herniotomy

Not Applicable

Completed

• Conditions: Ventral Hernia
• Interventions: Procedure: laparoscopic ventral herniotomy; Device: Glubran; Device: Securestrap; Device: Protack

• Registration Number: NCT01534780
• Lead Sponsor: Horsens Hospital

Brief 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

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Study Start: 2013-04
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• ventral hernia 2(1,5) < dia > 7 cm
• danish speaking
• of sound mind
• bmi < 35
• ASA 3 or less, no contra indication against laparoscopy

Exclusion Criteria

• other size hernias,
• no danish,
• bmi > 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
fixation with Securestrap	laparoscopic ventral herniotomy	-
fixation with Glubran	Glubran	surgery
fixation with Securestrap	Securestrap	-
fixation with Protack	Protack	-
fixation with Protack	laparoscopic ventral herniotomy	-
fixation with Glubran	laparoscopic ventral herniotomy	surgery

Primary Outcome Measures

Name	Time	Method
Pain	1 measurement, 2nd postoperative day	Dolo Test (VAS)

Secondary Outcome Measures

Name	Time	Method
hernia recurrence	7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60	clinical examination and perhaps CT scan
quality of life	7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60	SF 36 and Carolina's Comfort Scale
Pain	7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24	Dolo Test(VAS)

Trial Locations

Locations (1)

Regional Hospital Horsens; 🇩🇰 Horsens, Denmark