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

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ClinicalTrials.gov Identifier: NCT02233569
Recruitment Status : Terminated (The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.)
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Maciej Pawlak, Polish Hernia Study Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hernia, Abdominal Hernia,Ventral Procedure: 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 Ventralight ST implant with SorbaFix fixation device. Device: Ventralight ST implant Device: ETHICON PHYSIOMESH® Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: 7 days after the surgery ]
    Presence of pain 7 days after the surgery.

  2. Pain [ Time Frame: 3 months after the surgery ]
    Presence of pain 3 months after the surgery.


Secondary Outcome Measures :
  1. Number of Participants with Recurrences [ Time Frame: up to one year ]
    The recurrence rate in one year followup.

  2. Number of Participants with complications. [ Time Frame: up to one year ]
    The description and percentage distribution of short and long term complications following surgery.

  3. Pain intensity [ Time Frame: 7 days after the surgery ]
    Intensity of pain measured on a visual analogue scale 7 days after the surgery

  4. Pain intensity [ Time Frame: 30 days after the surgery ]
    Intensity of pain measured on a visual analogue scale 30 days after the surgery

  5. Pain intensity [ Time Frame: 3 months after the surgery ]
    Intensity of pain measured on a visual analogue scale 3 months after the surgery.

  6. Pain intensity [ Time Frame: 6 months after the surgery ]
    Intensity of pain measured on a visual analogue scale 6 months after the surgery.


Other Outcome Measures:
  1. Time of the operation [ Time Frame: intraoperative ]
    The duration of the surgical procedure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233569


Locations
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Poland
Ceynowa Hospital
Wejherowo, Pomorskie, Poland, 84-200
Sponsors and Collaborators
Polish Hernia Study Group
Investigators
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Principal Investigator: Maciej Pawlak, MD
Study Director: Maciej Śmietański, PhD
More Information
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Publications:

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Responsible Party: Maciej Pawlak, MD, Polish Hernia Study Group
ClinicalTrials.gov Identifier: NCT02233569    
Other Study ID Numbers: PHvsVS
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by Maciej Pawlak, Polish Hernia Study Group:
Laparoscopic hernia repair
Ventral hernia
Incisional hernia
IPOM
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Hernia, Ventral
Hernia, Abdominal
 Internal Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes