NCT04358159

Brief Summary

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2021Sep 2027

First Submitted

Initial submission to the registry

April 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

April 19, 2020

Last Update Submit

August 12, 2025

Conditions

Incisional Hernia of Midline of Abdomen

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

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

    One year

Secondary Outcomes (4)

  • Rate ofntra- and postoperative complications

    30 days

  • Rate of seroma

    one year

  • Persisting postoperative pain

    One year

  • Sick leave

    30 days

Study Arms (2)

Ventralex

EXPERIMENTAL

Repair with Ventralex patch in sublay position

Device: Ventralex

Progrip

ACTIVE COMPARATOR

Repair with Progrip in Onlay position

Device: Progrip

Interventions

VentralexDEVICE

Repair of the hernia by a Ventralex patch in sublay position

Ventralex
ProgripDEVICE

Repair of the hernia by a Progrip mesh in onlay position

Progrip

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karlskoga Hospital

Karlskoga, Sweden

NOT YET RECRUITING

Karlskoga Hospital

Karlskoga, Sweden

RECRUITING

Study Officials

  • Gabriel Sandblom, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, MD, PhD

CONTACT

+4686162362gabriel.sandblom@ki.se

Asmatullah Katawazai, MD

CONTACT

+46586660 00asmatullah.katawazai@regionorebrolan.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 24, 2020

Study Start

January 1, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)