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Ventralex vs Stratafix for Primary Ventral Hernias (VPatchPriRCT)

Primary Purpose

Ventral Hernia

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Ventralex

Stratafix

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

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

Inclusion Criteria:

Defect 1-4 cm
Primary ventral hernia in the midline
BMI<35

Exclusion Criteria:

Defect >4cm
BMI>35
Recurrent hernia

Sites / Locations

Karlskoga HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ventralex

Stratafix

Arm Description

Repair with Ventralex hernia patch in sublay position

Repair with Stratafix suture

Outcomes

Primary Outcome Measures

Hernia recurrence

Recurrence diagnosed at clinical and/or radiologic examination

Secondary Outcome Measures

Rate of intra-and postoperative complications

Complications occurring intraoperatively or in the postoperative period

Rate of seroma development

Seroma confirmed at follow-up examination

Persisting pain

Postoperative pain rated with the Ventral Hernia Pain Questionnaire. Pain rated on a scale from 1 to 7, with higher scores indicating more severe pain

Mean number of days postoperative sick leave

Postoperative sick leave

Full Information

NCT ID

NCT04356976

First Posted

April 19, 2020

Last Updated

March 1, 2023

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT04356976

Brief Title

Ventralex vs Stratafix for Primary Ventral Hernias

Acronym

VPatchPriRCT

Official Title

Randomised Controlled Trial of Ventralex Hernia Patch Versus Stratafix Suture for Midline Primary Ventral 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

Detailed Description

Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery. Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery. The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventral Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised controlled trial comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias

Masking

ParticipantOutcomes Assessor

Masking Description

The patient and the staff responsible for the postoperative care of the patient will be masked for the allocation.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ventralex

Arm Type

Experimental

Arm Description

Repair with Ventralex hernia patch in sublay position

Arm Title

Stratafix

Arm Type

Active Comparator

Arm Description

Repair with Stratafix suture

Intervention Type

Device

Intervention Name(s)

Ventralex

Intervention Description

Repair of hernia using Ventralex patch in sublay position

Intervention Type

Other

Intervention Name(s)

Stratafix

Intervention Description

Repair of hernia without mesh. Defect closed with Stratafix suture.

Primary Outcome Measure Information:

Title

Hernia recurrence

Description

Recurrence diagnosed at clinical and/or radiologic examination

Time Frame

One year

Secondary Outcome Measure Information:

Title

Rate of intra-and postoperative complications

Description

Complications occurring intraoperatively or in the postoperative period

Time Frame

30 days

Title

Rate of seroma development

Description

Seroma confirmed at follow-up examination

Time Frame

one year

Title

Persisting pain

Description

Postoperative pain rated with the Ventral Hernia Pain Questionnaire. Pain rated on a scale from 1 to 7, with higher scores indicating more severe pain

Time Frame

One year

Title

Mean number of days postoperative sick leave

Description

Postoperative 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

Eligibility Criteria

Inclusion Criteria: Defect 1-4 cm Primary ventral hernia in the midline BMI<35 Exclusion Criteria: Defect >4cm BMI>35 Recurrent hernia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gabriel Sandblom, MD, PhD

Phone

+4686162362

gabriel.sandblom@ki.se

First Name & Middle Initial & Last Name or Official Title & Degree

Asmatullah Katawazai, MD

Phone

+4658666000

asmatullah.katawazai@regionorebrolan.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriel Sandblom, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karlskoga Hospital

City

Karlskoga

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asmatullah Katawazai, MD

Phone

+4658666000

asmatullah.katawazai@regionorebrolan.se

First Name & Middle Initial & Last Name & Degree

Gabriel Sandblom, MD, PhD

gabriel.sandblom@ki.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ventralex vs Stratafix for Primary Ventral Hernias

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