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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03397901

Collaborator

(none)

Enrollment

Locations

Arm

52.4

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Radiation Proctitis Rectal Bleeding Colostomy Stoma Anemia	Procedure: Transverse colostomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Transverse colostomy Transverse double-cavity colostomy

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Transverse colostomy

Transverse double-cavity colostomy

Outcome Measures

Primary Outcome Measures

remission rate of rectal bleeding after colostomy [6 mon after colostomy]
retcal bleeding is assessed by soma scores

Secondary Outcome Measures

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
endoscopic score [1 year]
Score of Vienna Rectoscopy Score (VRS)
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510000
2	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	China	510655