Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair

Summary

Inguinal (groin) hernias are common and occur when an internal part of the body pushes through a weakness in the surrounding tissue wall of the groin. They are more likely to occur in men and affect people's quality of life by causing pain that is worse after any strenuous activity. If untreated they can cause serious problems such as strangulation when too much bowel comes through the weakness and becomes squeezed with the risk of losing blood supply requiring emergency surgery. To prevent such complications, elective surgery for symptomatic inguinal hernias is undertaken either in the conventional open method which involves a cut in the groin, or the keyhole surgery, when the surgery is undertaken via three small incisions in the abdomen (instead of a single, larger groin incision), a thin tube containing a light source and a camera (laparoscope) is inserted through one of these incisions, so the surgeon can see inside the abdomen. Special surgical instruments are inserted through the other incisions, so the surgeon can pull or push the hernia back into place and a piece of mesh is then stapled or glued to secure it to the weakened area in the abdomen wall. Securing the mesh with staple has been associated with increased post-operative pain and analgesia requirement; whereas not doing so has been thought to increase the chances of recurrence- more so in large sized weakness. A newer mesh appears to offer benefit over conventional meshes as it grips the tissues around the weakness without requiring staples or glue to fix it in place, and has shown to cause lesser post-operative pain and recurrence.

This study is going to compare the newer self-gripping mesh with the conventional mesh requiring fixation to see which is best for patients undergoing keyhole repair to fix inguinal hernias.

Conditions

• Inguinal Hernia

Interventions

DEVICE

self-gripping mesh

The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh (ProGripTM self-gripping mesh versus standard 'lightweight' (large pore) polypropylene mesh fixed with SecurestrapTM) which would be decided by randomization by sealed envelope into one of the 2 intervention groups: Group 1 (Self-gripping Mesh), Group 2 (Stapled Mesh).

DEVICE

Stapled mesh

The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh (ProGripTM self-gripping mesh versus standard 'lightweight' (large pore) polypropylene mesh fixed with SecurestrapTM) which would be decided by randomization by sealed envelope into one of the 2 intervention groups: Group 1 (Self-gripping Mesh), Group 2 (Stapled Mesh).

Sponsors & Collaborators

• Doncaster And Bassetlaw Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Srinivasan Balchandra, MS, MD, FRCS · Doncaster and Bassetlaw Teaching Hospitals NHS Foundation trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-22

Primary Completion

2024-12-31

Completion

2025-05-31

Countries

• United Kingdom

Study Locations