search
Back to results

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

Primary Purpose

Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transverse colostomy
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Radiation Proctitis focused on measuring chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The Sixth Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transverse colostomy

Arm 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.

Outcomes

Primary Outcome Measures

remission rate of rectal bleeding after colostomy
retcal bleeding is assessed by soma scores

Secondary Outcome Measures

Remission rate of rectal bleeding
retcal bleeding is assessed by soma scores
Rate of colostomy closure
assess endoscopic findings before closure
Rate of severe CRP complications
include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain
endoscopic score
Score of Vienna Rectoscopy Score (VRS)
endoscopic score
Score of Rectal Telangiectasia Density
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.
Anorectal function outcomes
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
such as prolapse, edema, necrosis, retraction.

Full Information

First Posted
December 26, 2017
Last Updated
July 11, 2019
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT03397901
Brief Title
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
Official Title
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma, Anemia
Keywords
chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transverse colostomy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Transverse colostomy
Intervention Description
Transverse double-cavity colostomy
Primary Outcome Measure Information:
Title
remission rate of rectal bleeding after colostomy
Description
retcal bleeding is assessed by soma scores
Time Frame
6 mon after colostomy
Secondary Outcome Measure Information:
Title
Remission rate of rectal bleeding
Description
retcal bleeding is assessed by soma scores
Time Frame
1 year, 2years, 3 years
Title
Rate of colostomy closure
Description
assess endoscopic findings before closure
Time Frame
1 years, 1.5 years, 2 years
Title
Rate of severe CRP complications
Description
include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain
Time Frame
3 years
Title
endoscopic score
Description
Score of Vienna Rectoscopy Score (VRS)
Time Frame
1 year
Title
endoscopic score
Description
Score of Rectal Telangiectasia Density
Time Frame
baseline, 6 months, 1 year, 2 years, 3 years
Title
Quality of life by EORTC scores
Description
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.
Time Frame
baseline, 6 months, 1 year, 2 years, 3 years
Title
Anorectal function outcomes
Description
by Wexner score including 5 items: incontinence of solid stool, watery stool, gas, necessary of nursing pads, change of living habit
Time Frame
baseline, 6 months, 1 year, 2 years, 3 years
Title
Rate of colostomy complications
Description
such as prolapse, edema, necrosis, retraction.
Time Frame
baseline, 6 months, 1 year, 2 years, 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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=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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Wang, Professor,MD
Phone
00861392618055
Email
wangl9@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zixu Yuan, MD,PhD
Phone
008618820107381
Email
yuanzx@mail2.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Wang, Professor
Organizational Affiliation
Sixth Affiliated Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Wang, M.D., Ph.D.
Phone
86-20-38254052
Email
leiwangyinhu@126.com
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zixu Yuan, MD, PhD
Phone
18820107381
Email
yuanzx@mail2.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD is private information
Citations:
PubMed Identifier
27350738
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.
Results Reference
background
PubMed Identifier
25834325
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs