A randomised control trial of mesh fixation with polypropylene sutures (prolene) versus polyglactin sutures (vicryl) sutures in assessing inguinodynia in open inguinal hernia repair.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less.
Study Overview
Brief Summary
Inguinal hernia, the most frequently occurring type of hernia globally, Chronic groin pain could be related to nerve mangling while operating. Mesh repair can lead to an inflammatory reaction over a period of time, though it still needs ground work to find out exact cause of pain. So this study aims to compare the effectiveness of polyglactin versus prolene sutures in reducing the post-operative pain in inguinal hernia repair. Chronic pain in the groin is a notable problem post Lichtenstien’s repair, even though the pain is usually mild, studies have revealed that irrespective of the severity, chronic pain may considerably hamper day to day activity. Chronic pain is the principle issue linked with the Lichtenstein technique with a conclusive rate between 15% and 40%. Routine usage of absorbable sutures to fix mesh in Lichtenstien’s repair have resulted in reduce post- operative chronic pain, yet controversies persist. So we took up this study to appraise post-operative groin pain in the patients where polyglactin sutures were used to fix the mesh (group A) versus polypropylene sutures in doing the same (group B) in Lichtenstein inguinal hernia repair. There have been many theories regarding the causes for the groin pain and one plausible theory is pain after surgery persists for a long period due to is inflammatory changes, fibrosis, subsequently entrapment of nerve, induced either by mesh or suture material, that’s in proximity of ilioinguinal nerve. Apart from this untimely mangling to nerve at the time of dissection may contribute as well to this. Vicryl (polyglactin) is a synthetic, absorbable, braided suture which can sustain its tensile strength for nearly 3 to 4 weeks in tissues. It’s entirely absorbed by hydrolysis within 60 days.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Inclusion Criteria:
- •Primary inguinal hernia
- •Uncomplicated hernia
- •Age range of 18 to 70 years
- •Unilateral or bilateral inguinal hernia
- •Nerve identification.
Exclusion Criteria
- •Exclusion criteria Irreducible hernias, patients with bleeding disorders, patients on anticoagulant treatment, pregnancy, patients needing emergency repair, HIV and HbsAg positive patients.
Outcomes
Primary Outcomes
Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less.
Time Frame: Post operative day 1, 3, 7 and 3 months
Secondary Outcomes
- Hence our study helps use to understand the benefits of using polyglactin sutures & also enables us to recommend its application to fix the mesh in Lichtenstien’s hernioplasty. So, routine usage of polyglactin (vicryl) sutures for mesh fixation in a Lichtenstien’s hernioplasty is safe & simple & thus a reasonable option.