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Safety and Efficacy of Sodium Hyaluronate Gel in Preventing Postoperative Peristomal Adhesions After Defunctioning Enterostomy: A prospective, randomized, controlled, clinical trial HPPA

Safety and Efficacy of Sodium Hyaluronate Gel in Preventing Postoperative Peristomal Adhesions After Defunctioning Enterostomy: A prospective, randomized, controlled, clinical trial HPPA

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054026
Enrollment
Unknown
Registered
2021-12-07
Start date
2018-07-14
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Postoperative Peristomal Adhesions After Defunctioning Enterostomy

Interventions

Group A:Hyaluronate Gel 6mg/ml
Group B:Hyaluronate Gel 10mg/ml
Group C:Hyaluronate Gel 10mg/ml

Sponsors

Peking University Shougang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. patients who need defunctioning enterostomy and surgical return within 3-6 months; 3. Voluntarily sign informed consent and complete postoperative follow-up on time

Exclusion criteria

Exclusion criteria: 1. patients allergic to sodium hyaluronate gel; 2. patents who do not need re-surgical return of enterostomy; 3. patients with surgical history at enterostomy site; 4. patients with combined endomertriosis and/or diffuse peritonitis; 5. patients with surgical contraindications. Including but not limited to: conjestive heart-failure, poorly controlled arrhythmia, poorly controlled hypertension(after treatment, BP,>140 mmHg/>90 mmHg); 6. patients allergic to Anesthetics and postoperative drugs; 7. pregnant and lactating women; 8. patients who participated other clinical trials within 30 days or are participating in other clinical trials; 9. patients who are not suitable to the clinical trial by suggestion of researcher 10. patients with abdominal fecal contamination found during surgery.

Design outcomes

Primary

MeasureTime frame
The incidence of moderate to severe adhesions;

Countries

China

Contacts

Public ContactGU JIN

Peking University Shougang Hospital

zlujin@126.com+86 10 57830088

Outcome results

None listed

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