NCT03397901

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

December 26, 2017

Last Update Submit

July 11, 2019

Conditions

Chronic Radiation ProctitisRectal BleedingColostomy StomaAnemia

Keywords

chronic radiation proctitisrectal bleedingtransverse colostomyrefractorymoderate to severe anemia

Outcome Measures

Primary Outcomes (1)

  • remission rate of rectal bleeding after colostomy

    retcal bleeding is assessed by soma scores

    6 mon after colostomy

Secondary Outcomes (8)

  • Remission rate of rectal bleeding

    1 year, 2years, 3 years

  • Rate of colostomy closure

    1 years, 1.5 years, 2 years

  • Rate of severe CRP complications

    3 years

  • endoscopic score

    1 year

  • endoscopic score

    baseline, 6 months, 1 year, 2 years, 3 years

  • +3 more secondary outcomes

Study Arms (1)

transverse colostomy

EXPERIMENTAL

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

Interventions

Transverse colostomyPROCEDURE

Transverse double-cavity colostomy

transverse colostomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 27350738BACKGROUND

  • 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.

    PMID: 25834325BACKGROUND

MeSH Terms

Conditions

Gastrointestinal HemorrhageAnemia

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lei Wang, Professor

    Sixth Affiliated Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Wang, Professor,MD

CONTACT

00861392618055wangl9@mail.sysu.edu.cn

Zixu Yuan, MD,PhD

CONTACT

008618820107381yuanzx@mail2.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 12, 2018

Study Start

July 20, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

IPD is private information

Locations

CN(2)