Back to resultsNationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
Primary Purpose
Hernia, Abdominal, Recurrence, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physiomesh
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Abdominal
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
Sites / Locations
- Dept. of surgery, Zealand University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Physiomesh
other mesh
Arm Description
Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.
Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.
Outcomes
Primary Outcome Measures
Re-operation for recurrence rate
Secondary Outcome Measures
30-day readmission rate
30-reoperation for complication rate
Full Information
NCT ID
NCT03846661
First Posted
February 4, 2019
Last Updated
February 25, 2019
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03846661
Brief Title
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
Official Title
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2010 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Abdominal, Recurrence, Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Register study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiomesh
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh.
Arm Title
other mesh
Arm Type
No Intervention
Arm Description
Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh.
Intervention Type
Device
Intervention Name(s)
Physiomesh
Other Intervention Name(s)
other mesh
Intervention Description
difference in risk for recurrence and postoperative complication
Primary Outcome Measure Information:
Title
Re-operation for recurrence rate
Time Frame
up to 84 months
Secondary Outcome Measure Information:
Title
30-day readmission rate
Time Frame
30 day
Title
30-reoperation for complication rate
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Helgstrand, MD
Organizational Affiliation
Dept. Surgery, Zealand university Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of surgery, Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
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