New Local Treatment of Radiation-induced Proctitis

NCT05489107 | Unknown

• 1 other identifier: 202207-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Proctitis

Keywords

radiation; proctitis; hyaluronic acid; chondroitin sulfate; poloxamer 407; local treatment; rectoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Petechiae in the most affected areas of the rectal mucosa.

  Assessment of the effects of the mixture on the number of petechiae in the rectum. Within the first flexible rectoscopy (Day 1) the most affected areas of the rectal mucosa (on the anterior and posterior wall) will be determined. A 27 mm CAPTIVATOR hexagonal polypectomy snare (Boston Scientific) will be introduced through the endoscope, and will be fully opened. The fully open polypectomy snare (9,2 cm2) will be applied over the most affected areas on the anterior and posterior rectal wall, and the number of the petechiae within these areas will be documented. The flexible rectoscopy will be repeated on day 8 after patients have already received enemas with the examined substance twice daily for one week, and the number of the petechiae will be documented as above mentioned. After a period of 23 days with no treatment, a follow-up flexible rectoscopy will be performed on day 31, and the petechiae of the rectal mucosa will be once more assessed.

  1 month

Secondary Outcomes (1)

• 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

Interventions

Ziverel OTHER

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 Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18 and 99 years of age with radiation proctitis under/after prior radiation therapy beacuse of oncological conditions in the pelvic area.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Barmherzige Brüder Vienna: lead

Study Sites (1)

Krankenhaus der Barmherzigen Brüder

Vienna, 1020, Austria

RECRUITING

MeSH Terms

Conditions

Proctitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases

Study Officials

• Bernhard Dauser, Assoc. Prof.

  Krankenhaus der Barmherzige Brüder Wien

  STUDY CHAIR

Central Study Contacts

Iliyan Iliev, MD

CONTACT

0043 1 21121; iliyaniliev18s@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, General Surgeon

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 31, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)