Anemia, Chronic Radiation Proctitis, Colostomy Stoma, Rectal Bleeding
Conditions
Keywords
chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia
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 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
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.
Interventions
PROCEDURETransverse colostomy
Transverse double-cavity colostomy
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| remission rate of rectal bleeding after colostomy | 6 mon after colostomy | retcal bleeding is assessed by soma scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of colostomy closure | 1 years, 1.5 years, 2 years | assess endoscopic findings before closure |
| Rate of severe CRP complications | 3 years | include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain |
| endoscopic score | 1 year | Score of Vienna Rectoscopy Score (VRS) |
| Remission rate of rectal bleeding | 1 year, 2years, 3 years | retcal bleeding is assessed by soma scores |
| Anorectal function outcomes | baseline, 6 months, 1 year, 2 years, 3 years | by Wexner score including 5 items: incontinence of solid stool, watery stool, gas, necessary of nursing pads, change of living habit |
| Rate of colostomy complications | baseline, 6 months, 1 year, 2 years, 3 years | such as prolapse, edema, necrosis, retraction. |
| Quality of life by EORTC scores | baseline, 6 months, 1 year, 2 years, 3 years | 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. |
Countries
China
Contacts
Primary ContactLei Wang, Professor,MD
Backup ContactZixu Yuan, MD,PhD
Outcome results
None listed