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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03397901
• Other study ID #: Colostomy-001
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 2022

Study information

• Verified date: July 2019
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Lei Wang, Professor,MD
• Phone: 00861392618055
• Email: wangl9[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Chronic Radiation Proctitis
• Colostomy Stoma
• Hemorrhage
• Proctitis
• Rectal Bleeding

Intervention

Procedure:
• Transverse colostomy
Transverse double-cavity colostomy

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Ma TH, Yuan ZX, Zhong QH, Wang HM, Qin QY, Chen XX, Wang JP, Wang L. Formalin irrigation for hemorrhagic chronic radiation proctitis. World J Gastroenterol. 2015 Mar 28;21(12):3593-8. doi: 10.3748/wjg.v21.i12.3593. — View Citation

Yuan ZX, Ma TH, Wang HM, Zhong QH, Yu XH, Qin QY, Wang JP, Wang L. Colostomy is a simple and effective procedure for severe chronic radiation proctitis. World J Gastroenterol. 2016 Jun 28;22(24):5598-608. doi: 10.3748/wjg.v22.i24.5598. — View Citation

Outcome

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