3 Fixation Devices in Laparoscopic Ventral Herniotomy

Ventral Hernia Clinical Trial

— FS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534780
• Other study ID #: KIR-001-HRH
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: August 2017

Study information

• Verified date: February 2020
• Source: Horsens Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Ventral
• Ventral Hernia

Intervention

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
• Securestrap
fixation of mesh with Securestrap
• Glubran
fixation of mesh with Glubran

Locations

Country	Name	City	State
Denmark	Regional Hospital Horsens	Horsens

Sponsors (2)

Lead Sponsor	Collaborator
Horsens Hospital	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Dolo Test (VAS)	1 measurement, 2nd postoperative day
Secondary	hernia recurrence	clinical examination and perhaps CT scan	7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Secondary	quality of life	SF 36 and Carolina's Comfort Scale	7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Secondary	Pain	Dolo Test(VAS)	7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24