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Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair

NCT03846661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3338

Last updated 2019-02-27

No results posted yet for this study

Summary

The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.

Conditions

  • Hernia, Abdominal
  • Recurrence
  • Postoperative Complications

Interventions

DEVICE

Physiomesh

difference in risk for recurrence and postoperative complication

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Frederik Helgstrand, MD · Dept. Surgery, Zealand university Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2017-11-01
Completion
2019-02-01

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 NCT03846661 on ClinicalTrials.gov