New Local Treatment of Radiation-induced Proctitis (NOTRIP)

Barmherzige Brüder Vienna

Status: Enrolling

Conditions: Radiation Proctitis

Treatments: Other: Ziverel

Study type: Observational

Funder types: Other

Identifiers

NCT05489107

202207-01

Details and patient eligibility

About

A prospective single-center observational study to evaluate the effectiveness of a local treatment with a mixture of hyaluronic acid, chondroitin sulfate and poloxamer 407 in patients with radiation-induced proctitis.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proven symptomatic acute or chronic radiation-induced proctitis;
• current or prior radiation therapy in the pelvic area;
• patients with complications connected to the radiation therapy.

Exclusion criteria

• lack of informed consent;
• non-adherence to study protocol;
• pregnancy.