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“Sutureless (self-fixating) mesh versus sutured mesh in open inguinal hernia repair: effects on postoperative pain.”

Sutureless (self-adhesive mesh) versus sutured mesh in open inguinal hernia repair: Effect on postoperative pain: A double-blind, randomized trial, Minia University Hospital experience

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602835273287
Enrollment
200
Registered
2026-02-03
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Interventions

Sponsors

Minia University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: • Male sex, age : 19-44 years. • Primary (first-time) unilateral inguinal hernia that is reducible on examination. • Scheduled elective open inguinal hernia repair with the Lichtenstein technique under spinal anesthesia. • Ability to provide informed consent and attend scheduled follow-up appointments for 6 months.

Exclusion criteria

Exclusion criteria: • Complicated hernia at presentation (irreducible/incarcerated/strangulated), need for emergency surgery, or concomitant femoral hernia. • Recurrent or bilateral inguinal hernia, giant inguinoscrotal hernia, or scheduled concomitant procedures. • Prior ipsilateral groin surgery that could modify anatomy or pain evaluation. • Current dermal or soft tissue infection at/near the surgery site or systemic disease at the time of surgery. • Chronic groin pain (=3 months) or opioid use. • Documented allergy to the mesh material or the study pain medications (paracetamol or diclofenac), or contraindication to NSAID use (e.g., severe renal impairment, active ulcer). • Inability to conduct follow-up (e.g., cognitive impairment, difficulty with questionnaires, or pending relocation).

Design outcomes

Primary

MeasureTime frame
Postoperative pain severity measured by Visual Analogue Scale (VAS 0–100) at postoperative day 1, 2 weeks, 2 months, 4 months, and 6 months (key comparison at 2 weeks), and incidence of chronic postoperative inguinal pain (CPIP) during follow-up (pain persisting =3 months, clinically significant threshold per protocol).

Secondary

MeasureTime frame
Health-related quality of life measured by SF-36 during follow-up. Operative time (minutes). Length of hospital stay. Time to return to work/normal activities. Postoperative complications (e.g., seroma, hematoma, wound infection). Hernia recurrence and/or reoperation during follow-up. Mesh-related symptoms: foreign-body sensation and numbness in the groin area.

Countries

Egypt

Contacts

Public ContactMichael Remon Roshdy Tawadrous

General Surgery Department

Michel.Remon@mu.edu.eg01068595406

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026