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

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ClinicalTrials.gov Identifier: NCT03397901
Recruitment Status : Not yet recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

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
Chronic Radiation Proctitis Rectal Bleeding Colostomy Stoma Anemia 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. remission rate of rectal bleeding after colostomy [ Time Frame: 6 mon after colostomy ]

Secondary Outcome Measures :
  1. Remission rate of rectal bleeding [ Time Frame: 1 year, 2years, 3 years ]
  2. Rate of colostomy closure [ Time Frame: 1 years, 1.5 years, 2 years ]
  3. Rate of severe CRP complications [ Time Frame: 3 years ]
    include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain

  4. endoscopic score [ Time Frame: baseline, 6 months, 1 year, 2 years, 3 years ]
    Score of Vienna Rectoscopy Score (VRS),including Congested mucosa, Telangiectasia Density, ulceration,necrosis, stricture

  5. endoscopic score [ Time Frame: baseline, 6 months, 1 year, 2 years, 3 years ]
    Score of Rectal Telangiectasia Density

  6. Quality of life [ Time Frame: 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.

  7. Anorectal function outcomes [ Time Frame: 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

  8. Rate of colostomy complications [ Time Frame: baseline, 6 months, 1 year, 2 years, 3 years ]
    such as prolapse, edema, necrosis, retraction.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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≥2 points;
  • Moderate to severe anemia (Hb≤9 g/dl).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397901


Contacts
Contact: Lei Wang, Professor,MD 00861392618055 wangl9@mail.sysu.edu.cn
Contact: Zixu Yuan, MD,PhD 008618820107381 yuanzx@mail2.sysu.edu.cn

Locations
China, Guangdong
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
Principal Investigator: Lei Wang, Professor Sixth Affiliated Hospital of Sun Yat-Sen University
More Information

Publications:
Responsible Party: Lei Wang, Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03397901     History of Changes
Other Study ID Numbers: Colostomy-001
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is private information

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lei Wang, Sixth Affiliated Hospital, Sun Yat-sen University:
chronic radiation proctitis
rectal bleeding
transverse colostomy
refractory
moderate to severe anemia

Additional relevant MeSH terms:
Anemia
Hemorrhage
Proctitis
Hematologic Diseases
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases