Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair

NCT03856710 | Unknown

• 1 other identifier: 0874/2017/CTN
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inguinal hernia; Groin hernia; Laparoscopy; Mesh

Outcome Measures

Primary Outcomes (2)

• Chronic pain rates Hernia recurrence rates

  Pain persisting beyond 3 months post inguinal hernia surgery

  12 months

• Hernia recurrence rates

  Clinical or radiological evidence of inguinal hernia at any time point

  12 months

Secondary Outcomes (7)

• Technical success

  1 day

• Operative time

  1 day

• Analgesia requirement

  1 week

• Perioperative complications including injury to organs, bleeding

  1 day

• Return to work and routine activities

  12 months

Study Arms (2)

Group 1 (Self-gripping Mesh),

ACTIVE COMPARATOR

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

Device: self-gripping mesh

Group 2 (Stapled Mesh)

ACTIVE COMPARATOR

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

Device: Stapled mesh

Interventions

self-gripping mesh DEVICE

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).

Group 1 (Self-gripping Mesh),

Stapled mesh DEVICE

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).

Group 2 (Stapled Mesh)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-elective acute presentation with inguinal hernia and its complications
• Inability to give informed written consent
• Groin symptoms which on clinical examination and radiological investigations fail to demonstrate any evidence of inguinal hernia.
• Pregnancy

Sponsors & Collaborators

• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: lead

Study Sites (1)

Doncaster and Bassetlaw Teaching Hospitals Nhs Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Srinivasan Balchandra, MS, MD, FRCS

  Doncaster and Bassetlaw Teaching Hospitals NHS Foundation trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Srinivasan Balchandra, MS, MD, FRCS

CONTACT

00447500856747; srinivasan.balchandra@nhs.net

Samer Wafai

CONTACT

00441302366666; s.wafai@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be unaware of the type of mesh received as the randomisation process will be carried out intraoperatively when the patient is under general anaesthesia. Subsequently, over the follow-up period every possible effort will be made to continue the blinding process in order to minimise any bias in patient reported outcomes. Similarly outcome assessors would be blinded as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blinded randomised controlled trial of ProGripTM self-gripping mesh versus standard 'lightweight' (large pore) polypropylene mesh fixed with SecurestrapTM an absorbable strap fixation device in the laparoscopic treatment of inguinal hernias. Sample size is 47 patients per group.

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: February 27, 2019
• Study Start: September 22, 2017
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after the Trial completion and will be available for 2 years
• Access Criteria: The study results will be shared with other researchers once completed. All listed and relevant participant Data, access criteria, statistics and clinical study report will be shared.

Locations

GB (1)