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Prospective, randomized, controlled, multicenter clinical study of precise repair of parastomal hernia

Prospective, randomized, controlled, multicenter clinical study of precise repair of parastomal hernia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036706
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Parastomal hernia

Interventions

Group 1:Sugarbaker type
Group 2:Lap-re-Do Sugarbaker type

Sponsors

Huashan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) parastomal hernia patient with a single tube through physical examination; 2) aged 15-75 years; 3) gender not limited; 4) those who voluntarily participate in the clinical study and can understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) BMI greater than 30kg/m2; 2) recurrent parastatal hernia; 3) with incisional hernia; 4) patients requiring emergency surgery due to incarceration and other problems; 5) preoperative examination or intraoperative indication of tumor recurrence or metastasis; 6) serious complications occurred during the operation, such as intestinal perforation and intestinal segment resection; 7) patients with contraindications; 8) cardiac dysfunction (> grade II cardiac function, arrhythmia, coronary heart disease), abnormal lung function, poor control of blood sugar and blood pressure, abnormal liver function, abnormal renal function , and abnormal coagulation function; 9) the body temperature of the patients with obvious systemic infection symptoms was greater than 38 degrees, white blood cells were greater than 1w, and N was greater than 75%; 10) local obvious symptoms of infection, local swelling, heat and pain around the stoma; 11) severe allergic rhinitis, asthma or other diseases that may cause allergic complications; 12) drug or alcohol abuse or diagnosis of mental illness; 13) lack of understanding of the possible complications of surgery; 14) patients and their families have poor compliance and cannot cooperate with clinical treatment and follow-up; 15) pregnancy status; 16) other circumstances in which the investigator considers the patient inappropriate for the clinical trial; 17) participating in other clinical studies at the same time.

Design outcomes

Primary

MeasureTime frame
Recurrence;

Secondary

MeasureTime frame
Stoma status;Patch Infection;Chronic pain;Quality of Life;

Countries

China

Contacts

Public ContactQiyuan Yao

Huashan Hospital of Fudan University

hs_cbms@sina.cn+86 13764093015, +86 13764093015

Outcome results

None listed

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