NCT03846661

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

7.8 years

First QC Date

February 4, 2019

Last Update Submit

February 25, 2019

Conditions

Hernia, AbdominalRecurrencePostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Re-operation for recurrence rate

    up to 84 months

Secondary Outcomes (2)

  • 30-day readmission rate

    30 day

  • 30-reoperation for complication rate

    30 day

Study Arms (2)

Physiomesh

ACTIVE COMPARATOR

Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.

Device: Physiomesh

other mesh

NO INTERVENTION

Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.

Interventions

PhysiomeshDEVICE

difference in risk for recurrence and postoperative complication

Also known as: other mesh
Physiomesh

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair

You may not qualify if:

  • If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of surgery, Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, AbdominalRecurrencePostoperative Complications

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Frederik Helgstrand, MD

    Dept. Surgery, Zealand university Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Register study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 20, 2019

Study Start

January 1, 2010

Primary Completion

November 1, 2017

Study Completion

February 1, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

DK(1)