Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort… (NCT03397901) | Clinical Trial Compass
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Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
China50 participantsStarted 2018-07-20
Plain-language summary
Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically diagnosed with pelvic malignancies, including gynecologic, prostate, or urinary cancers;
* History of pelvic radiation;
* No tumor recurrence or metastasis;
* Refractory hemorrhagic CRP;
* Time of rectal bleeding \>6 months;
* SOBS=3 points;
* severe anemia （Hb≤7 g/dl）or transfusion history for CRP bleedings.
Exclusion Criteria:
* Severe complications of CRP, including deep ulcer or fistula, stricture, necrosis, refractory perianal pain;
* Other hemorrhagic diseases, like III-IV degree hemorrhoids;
* History of colon or rectum resection;
* Intestinal obstruction and surgery needed;
* with contraindications to general anaesthesia (ASA class 4 or 5);
* pregnant or breast-feeding;
* history of mental disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
remission rate of rectal bleeding after colostomy
Timeframe: 6 mon after colostomy
Trial details
NCT IDNCT03397901
SponsorSixth Affiliated Hospital, Sun Yat-sen University