Prospective Randomized Trial of Laparoscopic Totally Extraperitoneal (TEP) Inguinal Hernioplasty with Partially Absorbable Light Weight Mesh versus Multifilament Polyester Anatomical Mesh

Prospective Randomized Trial comparing the mesh manipulating time of Laparoscopic Totally Extraperitoneal (TEP) Inguinal Hernioplasty with Partially Absorbable Light Weight Mesh versus Multifilament Polyester Anatomical Mesh

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000031066

Enrollment

Registered

2010-01-12

Start date

2009-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is performed to compare the two types of mesh commonly used in laparoscopic hernia repair.

Interventions

In this study, the surgical handling and clinical outcome of two totally different meshes use for laparoscopic inguinal hernia repair is compared. One is constructed with non-absorbable polypropylene (Prolene) mixed with an absorbable material poliglecaprone 25 (Monocryl) in a single sheet form. (ULTRAPROT, Ethicon Inc., manufactured by Johnson & Johnson Company) The other mesh we compare is a polyester multifilament mesh constructed in an anatomical form to fit the inguinal canal. (PARIETEXT polyester mesh, Tyco Healthcare Ltd., manufactured by Sofradim Production). Both types of mesh are applied by laparoscopic means into the extraperitoneal space permanently. The approximate duration of the procedure is 60-120 minutes. The primary endpoint is the mesh manipulating time;l therefore, the duration of procedure will be affected by the type of mesh used

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age 18 to 80 years 2. Medical fitness for general anesthesia 3. Suitability for laparoscopic TEP repair

Exclusion criteria

1. Not suitable for laparoscopic inguinal hernia repair 2. Not suitable for general anaesthesia 3. Suspected sliding hernia 4. Lower abdominal scar over operative region 5. On anticoagulant 6. Bleeding diathesis 7. Chronic liver disease with ascites or portal hypertension

Outcome results