Status:
UNKNOWN
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Chronic Radiation Proctitis
Rectal Bleeding
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
Chronic radiation proctitis (CRP) is a common complication after radiotherapy of pelvic malignancies, accounting for 5%-20% of cases. Rectal bleeding is the most common symptom, which accounts for \> ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03397901
Start Date
July 20 2018
End Date
December 1 2022
Last Update
July 15 2019
Active Locations (2)
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1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
2
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655