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

Hernia, Inguinal Clinical Trial

Official title:

Randomized Study of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - the 6 Years Result

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960011
• Other study ID #: HERN-PROGRIP-01
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: May 2016

Study information

• Verified date: April 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2016
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Device:
• PROGRIP
Use of PROGRIP mesh for open inguinal hernia repair
• POLYPROPYLENE
Use of Polypropylene mesh in open inguinal hernia repair

Locations

Country	Name	City	State
China	Department of Surgery, The University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong, Tung Wah Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Helbling C, Schlumpf R. Sutureless Lichtenstein: first results of a prospective randomised clinical trial. Hernia. 2003 Jun;7(2):80-4. Epub 2003 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating Time From Skin Incision to Wound Closure	It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.	Intra-operative record
Secondary	Mesh Placement Time, Total Operative Time	Time from mesh place to end of operation, and total time of operation	Intra-operative record
Secondary	Seroma Formation at First Follow-up	Seroma formation at first follow-up, go by clinical	1 week after operation
Secondary	Overall Recurrence at 6 Years	Overall recurrence at 6 years, including all recurrence	6 years after operation
Secondary	Chronic Pain at 6 Years	Patient with persistent chronic pain sensation at 6 years after operation. It described as painful sensation feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention.	6 years after operation
Secondary	Patient With Testicular Atrophy From Post-op to 6 Years After Operation	Patient with testicular atrophy from post-op to 6 years after operation, by clinical examination	6 years after operations
Secondary	Patient With Palpable Mesh at 6 Years After Operation	Patient with clinical palpable mesh at 6 years after operation	6 years after operation
Secondary	Patient With Chronic Discomfort at 6 Years After Operation	Patient with persistent chronic discomfort at 6 years after operation. It described as an unpleasant feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention. It is differentiate from pain sensation.	6 years after operation
Secondary	Pain or Discomfort Affecting Daily Activities at 6 Years After Operation	pain or discomfort which affecting daily activities at 6 years after operation	6 years after operation
Secondary	Total Number of Analgesic Used	Total Number of Analgesic Used: Tablets	1 week after operation
Secondary	Wound Pain at Rest at 1 Week After Operation	Visual Analogue Score for measurement of wound pain at rest 1 week after operation	1 week after operation
Secondary	Wound Pain on Coughing at 1 Week After Operation	wound pain on coughingt at 1 week after operation (Visual Analogue Score). It was in the form of 0-10 where 0 is no pain and 10 is maximal pain they experienced in their life. The higher the value, the more painful it is.	1 week after operation
Secondary	Post-operative Stay	Post-operative stay (number of hours)	1 week after operation
Secondary	Days go Outdoor	Post-op number of days that patient can go outdoor	1 week after operation
Secondary	Number of Participants Whose Response Was YES is Reported	Patient will be asked by assessor in out-patient clinic about satisfaction about the whole arrangement of operation. We did not intend to grade the satisfaction but simply ask whether they are satisfied. Will be either YES or NO answer.	1 week after operation
Secondary	Size of Mesh (Longitudinal)	Longitudinal size of mesh (in mm).	intra-operative record
Secondary	Size of Mesh (Vertical)	Vertical size of mesh (in mm).	intra-operative record
Secondary	Wound Size	Size of main wound	intra-operative record