3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

February 18, 2020 updated by: Hans Friis-Andersen, Horsens Hospital

A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as 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.

Study Overview

Detailed Description

see brief summary

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Horsens, Denmark, 8700
        • Regional Hospital Horsens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fixation with Protack
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
fixation of mesh with protack
Experimental: fixation with Securestrap
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
fixation of mesh with Securestrap
Experimental: fixation with Glubran
surgery
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
fixation of mesh with Glubran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 1 measurement, 2nd postoperative day
Dolo Test (VAS)
1 measurement, 2nd postoperative day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Sanne S Harsløf, MD, Horsens Regional Hospital
  • Study Director: Thorbjørn Sommer, MD, PhD, Randers Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KIR-001-HRH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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