Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Tung Wah Hospital
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00960011
First received: August 13, 2009
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation of the mesh with sutures is a tedious procedure and accounts for the majority of the operating time. A self gripping semi-absorbable mesh has been developed for anterior tension free inguinal hernia repair. It has the benefit of light weight property and does not require sutures for fixation. This study aims to compare the outcome of this self-gripping light weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.


Condition Intervention Phase
Inguinal Hernia Repair
Device: PROGRIP
Device: POLYPROPYLENE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - a Randomized Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Operating time from skin incision to wound closure [ Time Frame: Day 1 after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroma formation, post-operative pain, analgesic used, recurrence rate, chronic discomfort, patients satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROGRIP
Use of PROGRIP mesh for open inguinal hernia repair
Device: PROGRIP
Use of PROGRIP mesh for open inguinal hernia repair
Other Name: PROGRIP MESH
Active Comparator: POLYPROPYLENE
Use of Polypropylene mesh for open inguinal hernia repair
Device: POLYPROPYLENE
Use of Polypropylene mesh in open inguinal hernia repair
Other Name: Polypropylene mesh

  Hide Detailed Description

Detailed Description:

Tension free mesh repair is the most common procedure for inguinal hernia repair. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage when scar tissues are formed. In addition, the mesh requires fixation with sutures and there has been postulation that the fixation technique is related to postoperative chronic groin pain. Therefore, some authors have recommended the use of light-weight meshes and to limit the extent of fixation or to use non-compressive absorbable devices. In order to reduce the complications, a new self-gripping semi-resorbable mesh has been developed for anterior tension-free inguinal hernia repair.

The aim of this study is to compare the difference in operating time for open inguinal hernia repair with conventional prolene mesh and ProgripTM, which is a light-weight mesh with self-adhesive mechanism.

Methodology: Patients present with first episode of inguinal hernia are included into the study. Those with a sizable defect (>3cm defect), bilateral, inguino-scrotal hernia, irreducible, recurrence are excluded from study. Informed consents are signed before procedures and details of randomization are explained. Operations are performed by or under the supervision of specialist surgeons. Standardized inguinal dissection are performed. Randomization is carried out immediately before placement of mesh and after adequate inguinal dissection. PI / co-investigator phone to research assistant and ask for randomization result generated by computer. Total operative time, time from mesh placement to wound closure, blood loss, intra-operative complications, hospital stay, post-operative pain and analgesic used are documented.

Post-operative follow-up: Follow-up on day 14, 3 months, 6 months and 1 year post-op. Pain score, paraesthesia , chronic discomfort / pain, recurrence, seroma formation, testicular atrophy are documented. Thereafter, yearly follow-up is performed at clinic or by telephone to document the recurrence and chronic pain.

Parietene ProGrip™ (PP1208DR/ PP1208DL) Manufacturer: Sofradim Production Material: Monofilaments of polypropylene and polylactic acid (PLA) Color: Clear (undyed) Weight: 80g/m2 (before PLA resorbtion), 40g/m2 (after PLA resorbtion) Poresize: 1.7mm x 1mm

Material detailed description:

Parietene ProGrip™ is the first bio-component mesh comprised of monofilament polyester and a resorbable polylactic acid (PLA) gripping system which perfects true tension-free repair. The microhools cover the entire underside of the material allow complete anchoring of the mesh on the tissue. Self-gripping features also allows a strong and solid self-anchoring fixation and therefore making the hernia sac to fit perfectly to groin anatomy and move less underneath the prosthesis. Therefore, less suture is required and so operative time can be saved. Also less chance of nerve entrapment may cause low postoperative pain.

Surgipro Mesh (SPMM-35) Material: Monofilaments of polypropylene Color: Clear (undyed) Measurement: 15cmx15cm Thickness: 0.57mm

Description:

SURGIPRO Mesh is a non-absorbable, inert, sterile, porous surgical mesh knitted from mono-filament fibers of polypropylene polymer. The mesh exhibits high burst strength and tensile strength. The mesh is knitted in such fashion as to interconnect each mono-filament fiber and provide bi-dimensional elasticity while allowing the mesh to be cut to shape without unraveling.

Actions:

SURGIPRO Mesh is a porous, non-absorbable mesh used to repair or reinforce fascial defects following surgery or trauma and serves to provide additional support to such wounds during and following the wound healing period. Animal studies have shown that the polypropylene mono-filament fibers from which SURGIPRO Mesh is manufactured elicit a minimal acute inflammatory reaction in tissue, which is then followed by gradual encapsulation by fibrous tissue. In-growth of this fibrous tissue is permitted by the porosity of the knitted mesh structure. The mesh remains soft and pliable and the non-absorbable polypropylene fibers comprising the mesh resists loss of tensile strength in vivo.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 18 and below 90
  • Male or female patients
  • Unilateral inguinal hernia
  • First occurrence hernia

Exclusion Criteria:

  • Inguino-scrotal hernia
  • Recurrent inguinal hernia
  • Incarcerated hernia
  • Bilateral inguinal hernia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960011

Contacts
Contact: Joe KM Fan, MBBS FRCS 28554763 drjoefan@yahoo.com
Contact: WL Law, MBBS MS FRCS 28554763 lawwl@hku.hk

Locations
China
Department of Surgery, The University of Hong Kong Recruiting
HKSAR, China, China
Sub-Investigator: Oswens SH Lo, MBBS FRCS         
Sub-Investigator: KY Wong, MBBS FRCS         
Sub-Investigator: Jensen TC Poon, MBBS FRACS         
Sub-Investigator: WL Law, MBBS MS FRCS         
Sub-Investigator: Bernard Lim, MBBS FRCS         
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Tung Wah Hospital
Investigators
Principal Investigator: Joe KM Fan, MBBS FRCS Department of Surgery, The University of Hong Kong
  More Information

Publications:
Responsible Party: Dr. Joe KM Fan / Associate Consultant, Department of Surgery, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00960011     History of Changes
Other Study ID Numbers: HERN-PROGRIP-01
Study First Received: August 13, 2009
Last Updated: August 17, 2009
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Inguinal hernia
mesh
progrip

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 19, 2014