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

NCT00960011 | Completed Results

• 1 other identifier: HERN-PROGRIP-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

Inguinal hernia; mesh; progrip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Mesh Placement Time, Total Operative Time

  Intra-operative record

• Seroma Formation at First Follow-up

  1 week after operation

• Overall Recurrence at 6 Years

  6 years after operation

• Chronic Pain at 6 Years

  6 years after operation

• Patient With Testicular Atrophy From Post-op to 6 Years After Operation

  6 years after operations

Study Arms (2)

PROGRIP

EXPERIMENTAL

Use of PROGRIP mesh for open inguinal hernia repair

Device: PROGRIP

POLYPROPYLENE

ACTIVE COMPARATOR

Use of Polypropylene mesh for open inguinal hernia repair

Device: POLYPROPYLENE

Interventions

PROGRIP DEVICE

Use of PROGRIP mesh for open inguinal hernia repair

Also known as: PROGRIP MESH

PROGRIP

POLYPROPYLENE DEVICE

Use of Polypropylene mesh in open inguinal hernia repair

Also known as: Polypropylene mesh

POLYPROPYLENE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Tung Wah Hospital: collaborator

Study Sites (1)

Department of Surgery, The University of Hong Kong

Hong Kong, China

Location

Related Publications (4)

• 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.

  PMID: 19005611 BACKGROUND

• 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.

  PMID: 16862613 BACKGROUND

• 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.

  PMID: 12820029 BACKGROUND

• 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.

  PMID: 27889845 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size. Up to 15% (5) patients died at 6 years after operation in progrip group. All deaths were not related to the primary disease (hernia), its treatment (hernia repair), nor material used (mesh).

Results Point of Contact

• Title: Dr. Joe Fan King Man
• Organization: The University of Hong Kong

drfanj@gmail.com

852-22553111

Study Officials

• Joe KM Fan, MBBS MS FRCS

  Department of Surgery, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2016
• Last Updated: April 15, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years
• Access Criteria: clinical researchers

Locations

CN (1)