Phase 4
Completed N=104
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
Source: ClinicalTrials.gov NCT01117337 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. — 0; 0 Participant
Summary
The purpose of the study is
1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia
2. To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. |
0; 0 | — |
| PRIMARY Proportion of Patients Having Pain in the Post Operative Period |
3; 8 | 0.2 |
| SECONDARY Seroma Formation |
5; 8 | 0.56 |
Eligibility Criteria
Inclusion Criteria
- All reducible inguinal hernias will be included in the study
Exclusion Criteria
- Irreducible hernia after anesthesia
- Obstructed and strangulated hernias
- Pediatric hernias
- Associated other hernias like ventral hernias
- Unfit for spinal anesthesia
Data sourced from ClinicalTrials.gov (NCT01117337). 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. Informational only — not medical advice.