Comparing laparoscopic and open surgery for inguinal hernia repair
Pain and Quality of Life After Inguinal Hernia Repair. Randomized Study Comparing Laparoscopic TAPP Repair With Open Lichtenstein Repair (QoL-TAPP Study)
This study tests whether laparoscopic surgery or open surgery for inguinal hernia repair leads to less pain and better quality of life for patients after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04211142 on ClinicalTrials.gov |
What this trial studies
This investigation is a double-armed, randomized prospective study aimed at comparing the outcomes of open inguinal hernia repair using the Lichtenstein Technique versus laparoscopic repair using the TAPP method. The study will evaluate chronic pain, activity restrictions, and aesthetic outcomes preoperatively and at 1, 4, and 12 months post-surgery using the EuraHS-QoL score, a validated questionnaire. The goal is to determine which surgical approach results in better quality of life for patients after hernia repair.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a primary unilateral inguinal hernia.
Not a fit: Patients with bilateral hernias, recurrent hernias, or those requiring additional procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize chronic pain and enhance quality of life for patients undergoing inguinal hernia repair.
How similar studies have performed: Previous studies have suggested that laparoscopic repair may result in less chronic pain compared to open repair, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary inguinal hernia * unilateral hernia Exclusion Criteria: * bilateral hernia * recurrent hernia * incarcerated hernia * large scrotal hernia * known femoral hernia * need for associated procedures * not able to understand the questionaire * immunosuppression (including corticosteroids, radiotherapy, chemotherapy) * chronic renal failure (hemodialysis) * active infection * pregnancy * allergy to polypropylene or cyanoacrylate * patient's refusal and/or absence of informed consent
Where this trial is running
Barcelona
- Hospital Clínic — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Salvador Guillaumes, MD, PhD — Hospital Clinic of Barcelona
- Study coordinator: Salvador Guillaumes, MD, PhD
- Email: guillaumes@clinic.cat
- Phone: + 34 687 79 54 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.