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

Primary Purpose

Hernia, Abdominal, Hernia,Ventral

Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Ventralight ST implant
ETHICON PHYSIOMESH®
Sponsored by
Polish Hernia Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Abdominal focused on measuring Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ceynowa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PH

VS

Arm Description

Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.

Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.

Outcomes

Primary Outcome Measures

Pain
Presence of pain 7 days after the surgery.
Pain
Presence of pain 3 months after the surgery.

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2014
Last Updated
September 5, 2014
Sponsor
Polish Hernia Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT02233569
Brief Title
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Official Title
COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Polish Hernia Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Abdominal, Hernia,Ventral
Keywords
Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PH
Arm Type
Active Comparator
Arm Description
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Arm Title
VS
Arm Type
Active Comparator
Arm Description
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Other Intervention Name(s)
ETHICON PHYSIOMESH® Flexible Composite Mesh, ETHICON SECURESTRAP® Fixation Device
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Other Intervention Name(s)
BARD DAVOL INC., VENTRALIGHT™ ST Mesh, Proven Sepra® Technology in a Low Profile, Lightweight Mesh, ECHO PS™ Positioning System, SORBAFIX™Absorbable Fixation System
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Ventralight ST implant
Intervention Type
Device
Intervention Name(s)
ETHICON PHYSIOMESH®
Primary Outcome Measure Information:
Title
Pain
Description
Presence of pain 7 days after the surgery.
Time Frame
7 days after the surgery
Title
Pain
Description
Presence of pain 3 months after the surgery.
Time Frame
3 months after the surgery
Secondary Outcome Measure Information:
Title
Number of Participants with Recurrences
Description
The recurrence rate in one year followup.
Time Frame
up to one year
Title
Number of Participants with complications.
Description
The description and percentage distribution of short and long term complications following surgery.
Time Frame
up to one year
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 7 days after the surgery
Time Frame
7 days after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 30 days after the surgery
Time Frame
30 days after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
Time Frame
3 months after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
Time Frame
6 months after the surgery
Other Pre-specified Outcome Measures:
Title
Time of the operation
Description
The duration of the surgical procedure
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Pawlak, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maciej Śmietański, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Ceynowa Hospital
City
Wejherowo
State/Province
Pomorskie
ZIP/Postal Code
84-200
Country
Poland

12. IPD Sharing Statement

Citations:
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20976495
Citation
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Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

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