New Local Treatment of Radiation-induced Proctitis

New Option for the Treatment of Radiation-induced Proctitis Study

Sponsors

Lead Sponsor: Barmherzige Brüder Vienna

Source Barmherzige Brüder Vienna
Brief Summary

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.
Overall Status Recruiting
Start Date 2022-07-01
Completion Date 2023-07-31
Primary Completion Date 2023-07-01
Study Type Observational
Primary Outcome
Measure Time Frame
Number of Petechiae in the most affected areas of the rectal mucosa. 1 month
Secondary Outcome
Measure Time Frame
Assessment of patients' quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions (EORTC QLQ-PRT20) 6 months
Enrollment 50
Condition
Intervention

Intervention Type: Other

Intervention Name: Ziverel

Description: Within a first flexible rectoscopy (Day 1) the product will be applied transanally. Then the patients will apply it as enemas twice daily for 7 days. On day 8 (after treatment completion), and on day 31 (after 23 days of no treatment) follow-up flexible rectoscopies will be performed.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

99 Years

Healthy Volunteers:

No
Overall Official
Last Name Role Affiliation
Bernhard Dauser, Assoc. Prof. Study Chair Krankenhaus der Barmherzige Brüder Wien
Overall Contact

Last Name: Iliyan Iliev, MD

Phone: 0043 1 21121

Phone Ext.: 5285

Email: [email protected]

Location
Facility: Status: Contact: Krankenhaus der Barmherzigen Brüder Iliyan Iliev, MD 0043 1 21121 5285 [email protected]
Location Countries

Austria
Verification Date

2022-08-01
Responsible Party

Type: Principal Investigator

Investigator Affiliation: Barmherzige Brüder Vienna

Investigator Full Name: ILIYAN ILIEV

Investigator Title: Principal Investigator, General Surgeon

Keywords
Has Expanded Access No
Condition Browse
Acronym NOTRIP
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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