DOncaster MEsh Trial
Research type
Research Study
Full title
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
IRAS ID
217152
Contact name
Srinivasan Balchandra
Contact email
Sponsor organisation
Doncaster & Bassetlaw Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research 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.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0081
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion