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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Age \>18

• Demonstrated to have primary or recurrent unilateral or bilateral inguinal hernia

• Both patient and surgeon occupy a position of equipoise over the relative merits of either intervention

• Ability to give informed written consent

Locations
Other Locations
United Kingdom
Doncaster and Bassetlaw Teaching Hospitals Nhs Foundation Trust
RECRUITING
Doncaster
Contact Information
Primary
Srinivasan Balchandra, MS, MD, FRCS
srinivasan.balchandra@nhs.net
00447500856747
Backup
Samer Wafai
s.wafai@nhs.net
00441302366666
Time Frame
Start Date: 2017-09-22
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 47
Treatments
Active_comparator: Group 1 (Self-gripping Mesh),
The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh , which would be decided by randomization by sealed envelope. This group will receive self-gripping mesh
Active_comparator: Group 2 (Stapled Mesh)
The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh , which would be decided by randomization by sealed envelope. This group will receive stapled mesh
Related Therapeutic Areas
Sponsors
Leads: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov