New Option for the Treatment of Radiation-induced Proctitis Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation Proctitis
- Sponsor
- Barmherzige Brüder Vienna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Petechiae in the most affected areas of the rectal mucosa.
- Last Updated
- 3 years ago
Overview
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.
Investigators
ILIYAN ILIEV
Principal Investigator, General Surgeon
Barmherzige Brüder Vienna
Eligibility 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.
Outcomes
Primary Outcomes
Number of Petechiae in the most affected areas of the rectal mucosa.
Time Frame: 1 month
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.
Secondary Outcomes
- 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)