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Evaluation of Early Postoperative Application of EB Convex Baseplates in Adult Ostomy Patients: A Multicenter, Prospective, Open-Label Randomized Controlled Trial

Evaluation of Early Postoperative Application of EB Convex Baseplates in Adult Ostomy Patients: A Multicenter, Prospective, Open-Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120991
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Ostomy Patients

Interventions

Control Group:The control group will receive standard postoperative ostomy care. On postoperative day 1, patients use a flat baseplate and are instructed in the correct method of pouch application.
Intervention Group:The intervention group will receive standard postoperative care in addition to the immediate application of an appropriate EB convex baseplate on postoperative day 1.

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged >=18 years 2.Surgery involves ileostomy surgery 3.Patients and/or caregivers must be compliant and able to master the correct baseplate change method 4.Informed consent obtained, voluntary participation

Exclusion criteria

Exclusion criteria: 1. The presence of distant metastasis or other primary tumors; 2. Abnormal skin around the stoma; 3. Abdominal wall varices around the stoma; 4. American Society of Anesthesiologists (ASA) score >=4; 5. Patients with mucocutaneous separation of stoma; 6. Emergency surgery; 7. There are language communication barriers.

Design outcomes

Primary

MeasureTime frame
Stoma Baseplate Leakage;

Secondary

MeasureTime frame
Peristomal Moisture-associated Skin Damage;Stoma Output Height;Patient-Reported Experience;Stoma Quality of Life;

Countries

China

Contacts

Public ContactYujie Zhou

Peking University Third Hospital

yuejie218@sina.com+86 10 8226 7015

Outcome results

None listed

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