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A parallel controlled, single center clinical trial evaluating the effectiveness and safety of biological hernia repair patches for the treatment of occult inguinal hernia

A parallel controlled, single center clinical trial evaluating the effectiveness and safety of biological hernia repair patches for the treatment of occult inguinal hernia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091538
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

occult inguinal hernia

Interventions

Test group:Biological mesh repair for occult hernia
Control group:Synthetic mesh repair for occult hernia

Sponsors

Xiangya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 and = 85, male or female 2. Unilateral primary symptomatic inguinal hernia (Gilbert classification I-IVII), repaired by laparoscopic surgery 3. During the operation, a hidden hernia was found in the contralateral inguinal region (Gilbert classification I-IVII) and the patient agreed to repair it at the same time 4. Patients voluntarily participate in clinical trials, sign informed consent forms, and are able to cooperate with clinical follow-up

Exclusion criteria

Exclusion criteria: 1. Preoperative known bilateral inguinal hernias 2. Patients with incarcerated hernia/strangulated hernia, recurrent hernia or accompanied by intestinal obstruction 3. Those who cannot accept pig derived instruments due to religious, ethnic, and other issues 4. Individuals who have participated in clinical trials of other drugs or medical devices within the past 6 months 5. Patients with acute infections or poorly controlled lesions with skin diseases around the surgical incision 6. Severe heart, liver, and kidney dysfunction is defined as: • Cardiac function: Grade III and above ALT or AST>2.5 times the upper limit of normal values • Serum creatinine>2.5 times the upper limit of normal value 7. Individuals with specific allergic constitution 8. Significant abnormalities in coagulation function (prothrombin time prolonged>6 seconds) 9. Pregnant or planned pregnant women and lactating women 10. Individuals with mental disorders and lack of behavioral autonomy 11. Other situations where the doctor determines that the participant cannot participate in the experiment

Design outcomes

Primary

MeasureTime frame
Hernia recurrence rate;

Countries

China

Contacts

Public ContactHuang Gengwen

Xiangya Hospital

huanggengwen@csu.edu.cn+86 159 7419 4750

Outcome results

None listed

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