Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

September 5, 2014 updated by: Maciej Pawlak, Polish Hernia Study Group

COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Wejherowo, Pomorskie, Poland, 84-200
        • Ceynowa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent Form (ICF) signed by the patient or his/her legal representative
  • primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
  • recurrence after former abdominal hernia repair WITH MESH
  • recurrence after suture abdominal hernia repair CAN be included

Exclusion Criteria:

  • no written informed consent
  • patient under 18 years old
  • emergency surgery (incarcerated hernia)
  • patients with expected life time shorter than one year for example due to generalised malignancy
  • BMI exceeding 40.0kg/m²
  • contaminated surgical fields
  • patients on immunosuppression, steroid therapy, constant pain therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PH
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
Other Names:
  • ETHICON PHYSIOMESH® Flexible Composite Mesh
  • ETHICON SECURESTRAP® Fixation Device
Device: ETHICON PHYSIOMESH®
Active Comparator: VS
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
Other Names:
  • BARD DAVOL INC.
  • VENTRALIGHT™ ST Mesh
  • Proven Sepra® Technology in a Low Profile, Lightweight Mesh
  • ECHO PS™ Positioning System
  • SORBAFIX™Absorbable Fixation System
Device: Ventralight ST implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 7 days after the surgery
Presence of pain 7 days after the surgery.
7 days after the surgery
Pain
Time Frame: 3 months after the surgery
Presence of pain 3 months after the surgery.
3 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Recurrences
Time Frame: up to one year
The recurrence rate in one year followup.
up to one year
Number of Participants with complications.
Time Frame: up to one year
The description and percentage distribution of short and long term complications following surgery.
up to one year
Pain intensity
Time Frame: 7 days after the surgery
Intensity of pain measured on a visual analogue scale 7 days after the surgery
7 days after the surgery
Pain intensity
Time Frame: 30 days after the surgery
Intensity of pain measured on a visual analogue scale 30 days after the surgery
30 days after the surgery
Pain intensity
Time Frame: 3 months after the surgery
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
3 months after the surgery
Pain intensity
Time Frame: 6 months after the surgery
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
6 months after the surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of the operation
Time Frame: intraoperative
The duration of the surgical procedure
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polish Hernia Study Group

Investigators

  • Principal Investigator: Maciej Pawlak, MD
  • Study Director: Maciej Śmietański, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHvsVS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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