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

NCT ID: NCT03846661

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2019-02-01

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.

Detailed 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.

Conditions

Hernia, Abdominal; Recurrence; Postoperative Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiomesh

Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.

Group Type: ACTIVE_COMPARATOR

Physiomesh

Intervention Type: DEVICE

difference in risk for recurrence and postoperative complication

other mesh

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physiomesh

difference in risk for recurrence and postoperative complication

Intervention Type: DEVICE

Other Intervention Names

other mesh

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Frederik Helgstrand

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederik Helgstrand, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Surgery, Zealand university Hospital

Locations

Dept. of surgery, Zealand University Hospital

Køge, , Denmark

Countries

Denmark

Other Identifiers

FH115

Identifier Type: -

Identifier Source: org_study_id