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The promotion of modified Lichtenstein surgery with a new absorbable material in the treatment of inguinal hernia

A randomized, single-blind, parallel-controlled, multicenter clinical trial for evaluation of the efficacy and safety of electrospun poly (L-lactic acid-co-cprolactone) blended with a porcine fibrinogen biological patch in the treatment of inguinal hernia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025135
Enrollment
Unknown
Registered
2019-08-13
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

inguinal hernia

Interventions

test group:modified Lichtenstein tension-free repair
control group:Lichtenstein open tension-free repair

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male; 2. Aged 18-70 years; 3. Unilateral inguinal hernia diagnosed as Type I-III in accordance with the China Hernia Society Groin Hernia classification; 4. Patients with ASA physical status I-III; 5. Volunteer participation and signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Recurrent hernia, incarcerated hernia or bilateral hernia; 2. Allergic to anti-adhesion membranes; 3. Patients have surgical contraindications: such as severe cardiopulmonary disease, coagulopathy, liver and kidney dysfunction; 4. Patients with previous reproductive dysfunction or undergoing genitourinary surgery may affect reproductive function; 5. The life expectancy of patients with malignant tumors is less than 6 months; 6. Mental and neurological disorders cannot cooperate with doctors.

Design outcomes

Primary

MeasureTime frame
Efficacy rate (1-recurrence rate);

Secondary

MeasureTime frame
Degree of pain using VAS system;Quality of life score;Incidence of surgical site infection;Local foreign body sensation;Reproductive function complications;Other complications;AE/SAE;Concomitant medication;

Countries

China

Contacts

Public ContactJianxiong Tang

Huadong Hospital Affiliated to Fudan University

johnxiong@china.com+86 13901791469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026