NCT03856710

Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair

Status unknown NA Last updated 9 January 2024

What this trial tests

NA trial testing self-gripping mesh in Inguinal Hernia in 47 participants. Status unknown.

Timeline

22 September 2017

Primary endpoint
31 December 2024

31 May 2025

Quick facts

Lead sponsor	Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	47
Start date	22 September 2017
Primary completion	31 December 2024
Estimated completion	31 May 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• self-gripping mesh
• Stapled mesh

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Who can join

Adults 18 to 100, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.