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Clinical study to evaluate the efficacy and safety of intraperitoneal biohernia repair patch implanted with Sugarbaker method for preventing sigmoid or para-colostomy hernia

Clinical study to evaluate the efficacy and safety of intraperitoneal biohernia repair patch implanted with Sugarbaker method for preventing sigmoid or para-colostomy hernia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076269
Enrollment
Unknown
Registered
2023-09-28
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

sigmoid or para-colostomy hernia

Interventions

Experimental group:The Zhuoruan biologic hernia patch was implanted intraabdominally with Sugarbaker method

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects must meet the following criteria to participate in the study: 1. Age =18 years old and =75 years old, regardless of gender; 2. Patients requiring elective permanent sigmoidostomy or descending colostomy; 3. Patients undergoing permanent sigmoidostomy or descending colostomy for the first time; 4. The subjects or their guardians can understand the purpose of the experiment, are willing to cooperate with surgical treatment and follow-up, voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following exclusion criteria will be excluded: The following drugs or treatments should be excluded: 1. Patients with a life expectancy of less than 12 months; 2. Patients who have had other operations at the colostomy; 3. Patients with acute infection or poorly controlled focal infection have skin diseases around the surgical incision; 4. Patients with a clear history of allergy to collagen materials; 5. Patients with various malignant tumors and chronic wasting diseases causing bad fluid and unable to tolerate surgery; 6. Patients with failure of vital organs or suffering from other serious diseases; 7. Participants who have participated in other clinical trials within the last 3 months; 8. The investigator determined that the patient had other conditions that were not suitable for this test.

Design outcomes

Primary

MeasureTime frame
The preventive effectiveness of parastostomy hernia;

Secondary

MeasureTime frame
Quality of Life Score (SF-12);Incidence of postoperative complications;Incidence of adverse events and serious adverse events;Incidence of device defect;

Countries

China

Contacts

Public ContactFangqin Xue

Fujian Provincial Hospital

xuefangqingsl@sina.com+86 137 9995 9360

Outcome results

None listed

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