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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia; Rectal Bleeding; Colostomy Stoma; Chronic Radiation Proctitis
• Intervention / Treatment: Procedure: Transverse colostomy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Wang, Professor,MD; Phone Number: 00861392618055; Email: wangl9@mail.sysu.edu.cn
• Study Contact Backup: Name: Zixu Yuan, MD,PhD; Phone Number: 008618820107381; Email: yuanzx@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Zixu Yuan, MD, PhD; Phone Number: 18820107381; Email: yuanzx@mail2.sysu.edu.cn
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Lei Wang, M.D., Ph.D.; Phone Number: 86-20-38254052; Email: leiwangyinhu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
remission rate of rectal bleeding after colostomy	retcal bleeding is assessed by soma scores	6 mon after colostomy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Lei Wang, Professor, Sixth Affiliated Hospital of Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: chronic radiation proctitis; rectal bleeding; refractory; transverse colostomy; moderate to severe anemia
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Hemorrhage; Anemia; Proctitis
• Other Study ID Numbers: Colostomy-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD is private information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No