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

August 13, 2009
August 17, 2009
June 2009
May 2010   (final data collection date for primary outcome measure)
Operating time from skin incision to wound closure [ Time Frame: Day 1 after operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00960011 on ClinicalTrials.gov Archive Site
Seroma formation, post-operative pain, analgesic used, recurrence rate, chronic discomfort, patients satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair
Comparison of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - a Randomized Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia Repair
  • Device: PROGRIP
    Use of PROGRIP mesh for open inguinal hernia repair
    Other Name: PROGRIP MESH
  • Device: POLYPROPYLENE
    Use of Polypropylene mesh in open inguinal hernia repair
    Other Name: Polypropylene mesh
  • Experimental: PROGRIP
    Use of PROGRIP mesh for open inguinal hernia repair
    Intervention: Device: PROGRIP
  • Active Comparator: POLYPROPYLENE
    Use of Polypropylene mesh for open inguinal hernia repair
    Intervention: Device: POLYPROPYLENE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2011
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Joe KM Fan, MBBS FRCS 28554763 drjoefan@yahoo.com
Contact: WL Law, MBBS MS FRCS 28554763 lawwl@hku.hk
China
 
NCT00960011
HERN-PROGRIP-01
No
Dr. Joe KM Fan / Associate Consultant, Department of Surgery, The University of Hong Kong
The University of Hong Kong
  • Queen Mary Hospital, Hong Kong
  • Tung Wah Hospital
Principal Investigator: Joe KM Fan, MBBS FRCS Department of Surgery, The University of Hong Kong
The University of Hong Kong
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP