A Phase 4 interventional study of anterior hernia repair and transinguinal preperitoneal patch repair in Direct Inguinal Hernia and Indirect Inguinal Hernia, sponsored by San Bonifacio Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-10.
Sponsored by San Bonifacio Hospital · Phase 4, Interventional, and Treatment
Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications
Chronic pain is evaluated in all presenting types (achy, dull, etc.) moreover foreing body sensation, wall stiffness, paresthesia and numbness are controlled in each patients. Limiting of daily, working, sport and sexual activities (disejaculation) are reported as well.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 253 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →This is the only study on the registry with San Bonifacio Hospital as lead sponsor.
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Exclusion Criteria:
Procedure: anterior hernia repair
Procedure: transinguinal preperitoneal patch repair
Inguinal incision is made, external oblique divided and the cord is encircled after identifying ilioinguinal and iliohypogastric nerves. The sac is dissected and reduced, in case of direct hernia the posterior wall of inguinal canal is plicated with polypropylene suture; in presence of indirect hernia the sac is reduced and a stitch is passed in manner that the deep ring is snug about the cord. A pre-shaped mesh is positioned on the floor of the canal around the cord with the two tails overlapping laterally; the mesh is then anchored to the pubic tubercle. External oblique is reapproximated with the cord transposed in the subcutaneous space and skin is sutured.
Also known as: tension free hernia repair
Through a 5-cm inguinal incision external oblique fascia is divided, cremasteric fibers are separated and the elements of the cord are skeletonized. Indirect or direct hernia is approached and through the hernia orifice, the sac is reduced, preperitoneal space is accessed and dissected to allow easily placement of the patch facilitated by the memory recoil ring. In case of indirect hernia the lateral part of patch is split and the two tails sutured around vas and gonadic vessels. Hernia orifice is closed with a polypropylene stitch through transversalis fascia and the mesh; external oblique is closed followed by skin approximation.
Also known as: Polysoft™ Hernia Patch Bard®
chronic pain rate
phone interview and clinic visit
Time frame: 6 months
recurrence rate
clinic visit
Time frame: 2 years
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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