Comparing self-fixating mesh to stapled mesh for fixing inguinal hernias
A Double-blinded Randomised Controlled Trial Comparing the Clinical and Cost Effectiveness of Self-fixating Versus Stapled Mesh in the Laparoscopic Management of Inguinal Hernia
This study is testing whether a new type of mesh that sticks on its own works better than stapled mesh for fixing inguinal hernias in patients who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Doncaster And Bassetlaw Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Doncaster, South Yorkshire) |
| Trial ID | NCT03856710 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of self-fixating mesh versus stapled mesh in laparoscopic inguinal hernia repair. It is a double-blinded randomized controlled trial conducted at two district general teaching hospitals, targeting patients with symptomatic unilateral or bilateral inguinal hernias. Participants will undergo assessments for inclusion criteria, provide informed consent, and complete baseline quality of life evaluations before being randomly assigned to one of the two intervention groups. The study aims to evaluate postoperative outcomes and quality of life improvements following the surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic unilateral or bilateral inguinal hernias who can provide informed consent.
Not a fit: Patients with acute inguinal hernia presentations or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing inguinal hernia repair.
How similar studies have performed: Other studies have explored similar surgical techniques, but this specific comparison of self-fixating versus stapled mesh is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 * Demonstrated to have primary or recurrent unilateral or bilateral inguinal hernia * Both patient and surgeon occupy a position of equipoise over the relative merits of either intervention * Ability to give informed written consent Exclusion Criteria: * Non-elective acute presentation with inguinal hernia and its complications * Inability to give informed written consent * Groin symptoms which on clinical examination and radiological investigations fail to demonstrate any evidence of inguinal hernia. * Pregnancy
Where this trial is running
Doncaster, South Yorkshire
- Doncaster and Bassetlaw Teaching Hospitals Nhs Foundation Trust — Doncaster, South Yorkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Srinivasan Balchandra, MS, MD, FRCS — Doncaster and Bassetlaw Teaching Hospitals NHS Foundation trust
- Study coordinator: Srinivasan Balchandra, MS, MD, FRCS
- Email: srinivasan.balchandra@nhs.net
- Phone: 00447500856747
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.