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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846661
• Other study ID #: FH115
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Incisional Hernia
• Postoperative Complications
• Recurrence

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