Skip to main content
OpenTrials
Completed

NCT Number: NCT01534780

3 Fixation Devices in Laparoscopic Ventral Herniotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Horsens

Horsens, 8700, Denmark

About this study

see brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic ventral herniotomy

Procedure

Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices

Other names: no other names

ProTack

Device

fixation of mesh with protack

Securestrap

Device

fixation of mesh with Securestrap

Glubran

Device

fixation of mesh with Glubran

Primary outcomes

  1. Pain

    Time frame: 1 measurement, 2nd postoperative day

    Dolo Test (VAS)

Secondary outcomes

  1. hernia recurrence

    Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60

    clinical examination and perhaps CT scan

  2. quality of life

    Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60

    SF 36 and Carolina's Comfort Scale

  3. Pain

    Time frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24

    Dolo Test(VAS)

Sponsors and collaborators

Lead sponsor

Horsens Hospital

Other

Collaborators

  • Randers Regional Hospital

Registry information

Official study title

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

Acronym: FS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2012
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.