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Evaluation of the effectiveness and safety of biological mesh in treating inguinal hernia and abdominal hernia with or without contamination: a randonmized, single-blinded, parallel-controlled, multicenter clinical trial

Evaluation of the effectiveness and safety of biological mesh in treating inguinal hernia and abdominal hernia with or without contamination: a randonmized, single-blinded, parallel-controlled, multicenter clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036957
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-28

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

Conditions

Inguinal hernia

Interventions

Open herniorraphy (with biological mesh):Open herniorraphy (with biological mesh)
Open herniorraphy (with COOK‘s mesh):Open herniorraphy (with COOK‘s mesh)
laparoscopic herniorraphy (with biological mesh):laparoscopic herniorraphy (with biological mesh)
laparoscopic herniorraphy (with John&Johns mesh):laparoscopic herniorraphy (with John&Johns mesh)

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. >= 18 years old and <= 85 years old, male or female; 2. Gilbert type ?VII type inguinal hernia, abdominal wall hernia with hernia ring diameter <= 10cm; 3. Inguinal hernia or abdominal wall hernia incarceration/strangulation, combined or not combined with intestinal tract at the time of surgery or within 3 days before surgery, no continuous source of pollution (such as abscess, digestive tract fistula) in the operating area after treatment; 4. There is no absolute contraindication for primary hernia repair; 5. Patients voluntarily participate in clinical trials, sign informed consent, and be able to cooperate with clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. People who cannot accept pig-derived equipment due to religious or ethnic issues; 2. Participants in clinical trials of other drugs or medical devices in the last 6 months; 3. Severe heart, liver, and kidney insufficiency is defined as: Heart function: level III and above; ALT or AST > 2.5 times the upper limit of normal; Serum creatinine> 2.5 times the upper limit of normal; 4. Uncontrollable ascites caused by liver cirrhosis or tumor.

Design outcomes

Primary

MeasureTime frame
recurrence of hernia;

Secondary

MeasureTime frame
postoperative fever;Seroma in the surgical area;Surgical Site Infection;

Countries

China

Contacts

Public ContactZhang Jian

Shanghai Changzheng Hospital

txzhangjian@126.com+86 13817321198

Outcome results

None listed

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