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3 Fixation Devices in Laparoscopic Ventral Herniotomy

NCT01534780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-02-19

No results posted yet for this study

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.

Conditions

  • Ventral Hernia

Interventions

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

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • Horsens Hospital

    lead OTHER

Principal Investigators

  • Sanne S Harsløf, MD · Regionshospitalet Horsens

  • Thorbjørn Sommer, MD, PhD · Randers Regional Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534780 on ClinicalTrials.gov