Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study

Conditions
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Anemia, Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma

Intervention / Treatment
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* Procedure: Transverse colostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transverse colostomy<br>Diverting transverse colostomy were conducted under general or epidural anesthesia in the operating room. The transverse colon was pulled out through one 2*2cm incision. The omentum was dissected from transverse colon, and a double-cavity stoma of transverse colon was then created. | Procedure: Transverse colostomy<br>* Transverse double-cavity colostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate of rectal bleeding after colostomy | retcal bleeding is assessed by soma scores | 6 mon after colostomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate of rectal bleeding | retcal bleeding is assessed by soma scores | 1 year, 2years, 3 years | 
| Rate of colostomy closure | assess endoscopic findings before closure | 1 years, 1.5 years, 2 years | 
| Rate of severe CRP complications | include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain | 3 years | 
| endoscopic score | Score of Vienna Rectoscopy Score (VRS) | 1 year | 
| endoscopic score | Score of Rectal Telangiectasia Density | 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. | 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 | baseline, 6 months, 1 year, 2 years, 3 years | 
| Rate of colostomy complications | such as prolapse, edema, necrosis, retraction. | baseline, 6 months, 1 year, 2 years, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia