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.
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 \> 80% of CRP patients. Mild to moderate bleeding can be controlled by medical agents like sucralfate, endoscopic argon plasma coagulation (APC) or topical formalin. Severe and refractory bleeding is still problematic and refractory to these above medical treatments. Our previous retrospective study found that colostomy obtained a higher rate of bleeding remission (94% vs 12%) in 6 months, especially in control of transfusion-dependent bleeding (100% vs0%), when compared to conservative treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Transverse double-cavity colostomy
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGremission rate of rectal bleeding after colostomy
retcal bleeding is assessed by soma scores
Time frame: 6 mon after colostomy
Remission rate of rectal bleeding
retcal bleeding is assessed by soma scores
Time frame: 1 year, 2years, 3 years
Rate of colostomy closure
assess endoscopic findings before closure
Time frame: 1 years, 1.5 years, 2 years
Rate of severe CRP complications
include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain
Time frame: 3 years
endoscopic score
Score of Vienna Rectoscopy Score (VRS)
Time frame: 1 year
endoscopic score
Score of Rectal Telangiectasia Density
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Quality of life by EORTC scores
The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30),The EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the quality-of-life construct. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and quality-of-life scale.
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Anorectal function outcomes
by Wexner score including 5 items: incontinence of solid stool, watery stool, gas, necessary of nursing pads, change of living habit
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Rate of colostomy complications
such as prolapse, edema, necrosis, retraction.
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
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