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

Zealand University Hospital

Status: Completed

Conditions: Postoperative Complications; Hernia, Abdominal; Recurrence

Treatments: Device: Physiomesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03846661

FH115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,338 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,338 participants in 2 patient groups

Physiomesh

Active Comparator group

Description:

Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.

Treatment:

Device: Physiomesh

other mesh

No Intervention group

Description:

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