New Local Treatment of Radiation-induced Proctitis

NCT ID: NCT05489107

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Radiation Proctitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ziverel

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barmherzige Brüder Vienna

OTHER

Sponsor Role lead

Responsible Party

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ILIYAN ILIEV

Principal Investigator, General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard Dauser, Assoc. Prof.

Role: STUDY_CHAIR

Krankenhaus der Barmherzige Brüder Wien

Locations

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Krankenhaus der Barmherzigen Brüder

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Iliyan Iliev, MD

Role: CONTACT

0043 1 21121 ext. 5285

Facility Contacts

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Iliyan Iliev, MD

Role: primary

0043 1 21121 ext. 5285

Other Identifiers

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202207-01

Identifier Type: -

Identifier Source: org_study_id

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