A clinical trial on the safety and effectiveness of composite hernia repair patch in patients undergoing laparoscopic inguinal hernia repair

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041089

Enrollment

Unknown

Registered

2020-12-17

Start date

2021-01-15

Completion date

Unknown

Last updated

2021-03-01

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

Conditions

Inguinal Hernia

Interventions

Experimental group:The composite hernia repair patch will be implanted under the endoscope

Control Group:the ULTRAPRO Mesh will be implanted under the endoscope

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Patients with unilateral inguinal hernia; 3. Hernia repair is required without absolute contraindications; 4. Patients who meet the American Society of Anesthesiologists rating I-III; 5. Patients or their guardians can understand the purpose of the study, are willing to cooperate with surgical treatment and follow-up, participate in the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with bilateral inguinal hernia, incarcerated hernia/strangulated hernia, recurrent hernia or intestinal obstruction; 2. Patients with definite history of allergy to test materials (PLCL, fibrinogen); 3. Patients with acute infection or with poor control of infection of the lesions, or with skin diseases around the surgical incision; 4. Patients with serious diseases causing increased intra-abdominal pressure; 5. Combined with various malignant tumors and chronic wasting diseases, resulting in bad fluid, unable to tolerate surgery; 6. Patients with major organ failure or other serious diseases; 7. Participated in other clinical trials in recent 3 months; 8. The investigators determined that the patient had other factors that were not suitable for this trial.

Design outcomes

Primary

Measure	Time frame
Effectiveness at 12 months after implantation;	—

Secondary

Measure	Time frame
Immediate surgical success rate;Effectiveness at 1 and 6 months after implantation;Changes in VAS of pain at 1, 6, and 12 months after implantation;	—

Countries

China

Contacts

Public ContactLi Jianwen

Ruijin Hospitial Affiliated to Shanghai Jiaotong University School of Medicine

ljw5@yeah.net+86 13901710404

Outcome results

None listed

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