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RCT Ventralex vs Onlay Mesh in Incisional Hernias (VPatchIncRCT)

Primary Purpose

Incisional Hernia of Midline of Abdomen

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ventralex
Progrip
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia of Midline of Abdomen

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hernia defect 1-4 cm
  • Incisional hernia or recurrent hernia after previous primary hernia repair
  • BMI <35
  • Age 18-100 years

Exclusion Criteria:

  • Defect size>4 cm
  • Ongoing pregnancy
  • BMI>35
  • Primary hernia

Sites / Locations

  • Karlskoga Hospital
  • Karlskoga HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ventralex

Progrip

Arm Description

Repair with Ventralex patch in sublay position

Repair with Progrip in Onlay position

Outcomes

Primary Outcome Measures

Recurrence rate
Rate of hernia recurrences diagnosed at clinical and/or radiologic examination

Secondary Outcome Measures

Rate ofntra- and postoperative complications
Rate of complications occurring during or after the repair
Rate of seroma
Postoperative seroma
Persisting postoperative pain
Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire
Sick leave
Mean number of postoperative days sick leave

Full Information

First Posted
April 19, 2020
Last Updated
March 1, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04358159
Brief Title
RCT Ventralex vs Onlay Mesh in Incisional Hernias
Acronym
VPatchIncRCT
Official Title
Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias
Detailed Description
Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities. Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia of Midline of Abdomen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ventralex
Arm Type
Experimental
Arm Description
Repair with Ventralex patch in sublay position
Arm Title
Progrip
Arm Type
Active Comparator
Arm Description
Repair with Progrip in Onlay position
Intervention Type
Device
Intervention Name(s)
Ventralex
Intervention Description
Repair of the hernia by a Ventralex patch in sublay position
Intervention Type
Device
Intervention Name(s)
Progrip
Intervention Description
Repair of the hernia by a Progrip mesh in onlay position
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Rate of hernia recurrences diagnosed at clinical and/or radiologic examination
Time Frame
One year
Secondary Outcome Measure Information:
Title
Rate ofntra- and postoperative complications
Description
Rate of complications occurring during or after the repair
Time Frame
30 days
Title
Rate of seroma
Description
Postoperative seroma
Time Frame
one year
Title
Persisting postoperative pain
Description
Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire
Time Frame
One year
Title
Sick leave
Description
Mean number of postoperative days sick leave
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hernia defect 1-4 cm Incisional hernia or recurrent hernia after previous primary hernia repair BMI <35 Age 18-100 years Exclusion Criteria: Defect size>4 cm Ongoing pregnancy BMI>35 Primary hernia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Sandblom, MD, PhD
Phone
+4686162362
Email
gabriel.sandblom@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Asmatullah Katawazai, MD
Phone
+46586660 00
Email
asmatullah.katawazai@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karlskoga Hospital
City
Karlskoga
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmatullah Katawazai, MD
Facility Name
Karlskoga Hospital
City
Karlskoga
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmatullah Katawazai, MD
Email
asmatullah.katawazai@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Gabriel Sandblom, MD, PhD
Email
gabriel.sandblom@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RCT Ventralex vs Onlay Mesh in Incisional Hernias

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