A randomized controlled clinical trial of compound hernia repair patch in laparoscopic transabdominal preperitoneal inguinal hernia repair

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039294

Enrollment

Unknown

Registered

2020-10-22

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-01-25

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

Conditions

Inguinal hernia

Interventions

Trial group:Composite hernia repair patch

Control group:Polypropylene patch

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years, regardless of gender; 2. Patients with unilateral primary inguinal hernia diagnosed clinically as type II-V (Gilbert classification); 3. Patients who need hernia repair have no contraindications; 4. The patients who voluntarily participate in the clinical trial sign the informed consent and can cooperate with the clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in clinical trials of other drugs or medical devices in recent 6 months; 2. Patients with bilateral inguinal hernia, femoral hernia, incarcerated hernia and recurrent hernia; 3. Patients with acute infection or poor control of focal infection; 4. Patients with skin diseases around the incision; 5. Patients with serious diseases that cause increased intra-abdominal pressure (such as severe prostatic hyperplasia, constipation or chronic cough; uncontrollable ascites caused by liver cirrhosis or tumor, etc.); 6. Patients with severe heart, liver and kidney dysfunction (heart function: Grade II or above; ALT or ast > 2.5 times of the upper limit of normal value; serum creatinine > the upper limit of normal value); 9. Patients with poor control of diabetes mellitus (fasting blood glucose >= 8.8 mmol / L monitored twice in a row); 10. Patients with severe heart, lung and brain diseases, cancer and AIDS; 11. Patients with specific allergic constitution; 12. Patients whose life expectancy is less than 6 months; 13. Patients with mental disorders and no ability of behavior autonomy; 14. Pregnant or planned pregnant women and lactating women; 15. Other circumstances in which doctors judge that they can not participate in the trial.

Design outcomes

Primary

Measure	Time frame
The incidence of foreign body sensation in half a year;One-year hernia recurrence rate;	—

Countries

China

Contacts

Public ContactTai Chengzhou

The Sixth Affiliated Hospital of Sun Yat-Sen University

zhoutaicheng@126.com13631466079

Outcome results

None listed

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