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

Sun Yat-sen University

Status: Unknown

Conditions: Anemia; Rectal Bleeding; Colostomy Stoma; Chronic Radiation Proctitis

Treatments: Procedure: Transverse colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03397901

Colostomy-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

transverse colostomy

Experimental group

Description:

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.

Treatment:

Procedure: Transverse colostomy