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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 range18 Years – 80 Years

SexALL

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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.

What they're measuring

remission rate of rectal bleeding after colostomy

Timeframe: 6 mon after colostomy

Trial details

NCT IDNCT03397901

SponsorSixth Affiliated Hospital, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

Contact for this trial

Lei Wang, Professor,MD

00861392618055 wangl9@mail.sysu.edu.cn

View on ClinicalTrials.gov More Chronic Radiation Proctitis trials