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

Not Applicable

• Conditions: Anemia; Chronic Radiation Proctitis; Colostomy Stoma; Rectal Bleeding
• Interventions: Procedure: Transverse colostomy

• Registration Number: NCT03397901
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-12
• Study Start: 2018-07-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15
• Primary Completion: 2020-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transverse colostomy	Transverse colostomy	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.

Primary Outcome Measures

Name	Time	Method
remission rate of rectal bleeding after colostomy	6 mon after colostomy	retcal bleeding is assessed by soma scores

Secondary Outcome Measures

Name	Time	Method
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
endoscopic score	baseline, 6 months, 1 year, 2 years, 3 years	Score of Rectal Telangiectasia Density
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.
Remission rate of rectal bleeding	1 year, 2years, 3 years	retcal bleeding is assessed by soma scores
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
Rate of colostomy complications	baseline, 6 months, 1 year, 2 years, 3 years	such as prolapse, edema, necrosis, retraction.

Trial Locations

Locations (2)

The Sixth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China