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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846661
Other study ID # FH115
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2010
Est. completion date February 1, 2019

Study information

Verified date February 2019
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.

To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.

Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).

Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect

The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.

The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.


Recruitment information / eligibility

Status Completed
Enrollment 3338
Est. completion date February 1, 2019
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Intervention

Device:
Physiomesh
difference in risk for recurrence and postoperative complication

Locations

Country Name City State
Denmark Dept. of surgery, Zealand University Hospital Køge

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Re-operation for recurrence rate up to 84 months
Secondary 30-day readmission rate 30 day
Secondary 30-reoperation for complication rate 30 day
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