Clinical trial NCT00960011: Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair
Official title: Randomized Study of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - the 6 Years Result
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Inguinal hernia
mesh
progrip
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Tung Wah Hospital
First posted: 2009-08-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Age above 18 and below 80
* Male or female patients
* Unilateral inguinal hernia
* First occurrence hernia

Exclusion Criteria:

* Inguino-scrotal hernia
* Recurrent inguinal hernia
* Incarcerated hernia
* Bilateral inguinal hernia

Primary outcomes:
measure: Operating Time From Skin Incision to Wound Closure
timeFrame: Intra-operative record
Secondary outcomes:
measure: Mesh Placement Time, Total Operative Time
timeFrame: Intra-operative record
measure: Seroma Formation at First Follow-up
timeFrame: 1 week after operation
measure: Overall Recurrence at 6 Years
timeFrame: 6 years after operation
measure: Chronic Pain at 6 Years
timeFrame: 6 years after operation
measure: Patient With Testicular Atrophy From Post-op to 6 Years After Operation
timeFrame: 6 years after operations
measure: Patient With Palpable Mesh at 6 Years After Operation
timeFrame: 6 years after operation
measure: Patient With Chronic Discomfort at 6 Years After Operation
timeFrame: 6 years after operation
measure: Pain or Discomfort Affecting Daily Activities at 6 Years After Operation
timeFrame: 6 years after operation
measure: Total Number of Analgesic Used
timeFrame: 1 week after operation
measure: Wound Pain at Rest at 1 Week After Operation
timeFrame: 1 week after operation
measure: Wound Pain on Coughing at 1 Week After Operation
timeFrame: 1 week after operation
measure: Post-operative Stay
timeFrame: 1 week after operation
measure: Days go Outdoor
timeFrame: 1 week after operation
measure: Number of Participants Whose Response Was YES is Reported
timeFrame: 1 week after operation
measure: Size of Mesh (Longitudinal)
timeFrame: intra-operative record
measure: Size of Mesh (Vertical)
timeFrame: intra-operative record
measure: Wound Size
timeFrame: intra-operative record
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, The University of Hong Kong
Study officials:
affiliation: Department of Surgery, The University of Hong Kong
name: Joe KM Fan, MBBS MS FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009 Apr;13(2):137-42. doi: 10.1007/s10029-008-0451-4. Epub 2008 Nov 13.
citation: Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund H, Heikkinen TJ. Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. Br J Surg. 2006 Sep;93(9):1056-9. doi: 10.1002/bjs.5403.
citation: Helbling C, Schlumpf R. Sutureless Lichtenstein: first results of a prospective randomised clinical trial. Hernia. 2003 Jun;7(2):80-4. doi: 10.1007/s10029-002-0114-9. Epub 2003 Jan 30.
citation: Fan JKM, Yip J, Foo DCC, Lo OSH, Law WL. Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result. Hernia. 2017 Feb;21(1):9-16. doi: 10.1007/s10029-016-1545-z. Epub 2016 Nov 26.