N/A
N=58
Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair
Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT00960011 ↗Enrolled (actual)
58
Serious AEs
11.1%
Results posted
Apr 2020
Primary outcome: Primary: Operating Time From Skin Incision to Wound Closure — 39.2; 47.7 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PROGRIP (Device); POLYPROPYLENE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Hong Kong
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operating Time From Skin Incision to Wound Closure |
39.2; 47.7 | — |
| SECONDARY Mesh Placement Time, Total Operative Time |
21; 11.8; 47.7; 39.2 | — |
| SECONDARY Seroma Formation at First Follow-up |
5; 8 | — |
| SECONDARY Overall Recurrence at 6 Years |
0; 1 | — |
| SECONDARY Chronic Pain at 6 Years |
3; 3 | — |
| SECONDARY Patient With Testicular Atrophy From Post-op to 6 Years After Operation |
1; 2 | — |
| SECONDARY Patient With Palpable Mesh at 6 Years After Operation |
1; 3 | — |
| SECONDARY Patient With Chronic Discomfort at 6 Years After Operation |
1; 1 | — |
| SECONDARY Pain or Discomfort Affecting Daily Activities at 6 Years After Operation |
1; 0 | — |
| SECONDARY Total Number of Analgesic Used |
10.4; 6.7 | — |
| SECONDARY Wound Pain at Rest at 1 Week After Operation |
0.18; 0.13 | — |
| SECONDARY Wound Pain on Coughing at 1 Week After Operation |
0.81; 0.83 | — |
| SECONDARY Post-operative Stay |
41.2; 28.6 | — |
| SECONDARY Days go Outdoor |
2.5; 3.7 | — |
| SECONDARY Number of Participants Whose Response Was YES is Reported |
20; 23 | — |
| SECONDARY Size of Mesh (Longitudinal) |
110.7; 106.7 | — |
| SECONDARY Size of Mesh (Vertical) |
72; 66.7 | — |
| SECONDARY Wound Size |
50.7; 53.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00960011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.