An observational study in Radiation Proctitis, sponsored by Barmherzige Brüder Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Barmherzige Brüder Vienna · Observational
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.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
Browse Proctitis studies →Barmherzige Brüder Vienna is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients between 18 and 99 years of age with radiation proctitis under/after prior radiation therapy beacuse of oncological conditions in the pelvic area.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1 month
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)
The effects of the mixture on subjects' quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions Score (EORTC QLQ-PRT20). The questionnaire consists of 18 quantitative, 2 qualitative (one of them being optional), and 1 semi-quantitative questions . Using the quantitative questions, a score can be defined. Its minimum value is 18 (meaning patients have no symptoms), and its maximum value is 72 (meaning greatest extent of lifestyle limitations because of radiation proctitis). The semi-quantitative question provides information about the highest number of defecations per 24 hours and is not included in the score. The qualitative questions determine the use of medicines, and patients' will to receive any assistance concerning their symptoms. The score will be documented on day 1, 8, 31 and 6 months after treatment completion.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Jul 2023, 12 months after the start.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Barmherzige Brüder Vienna