Chronic Radiation ProctitisNCT03397901
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study
A study testing Transverse colostomy in people with Chronic Radiation Proctitis and Rectal Bleeding, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma
- What is being tested?
- Transverse colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Lei Wang, M.D., Ph.D., 86-20-38254052, leiwangyinhu@126.com
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Zixu Yuan, MD, PhD, 18820107381, yuanzx@mail2.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma, Anemia
- Being tested
- Transverse colostomy
- Keywords
- chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia
- Medical subject headings
- Gastrointestinal Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse colostomyProcedure or surgery
Transverse double-cavity colostomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transverse colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission rate of rectal bleeding after colostomy
retcal bleeding is assessed by soma scores
Measured: 6 mon after colostomy
Secondary outcomes (8)
Remission rate of rectal bleeding
retcal bleeding is assessed by soma scores
Measured: 1 year, 2years, 3 years
Rate of colostomy closure
assess endoscopic findings before closure
Measured: 1 years, 1.5 years, 2 years
Rate of severe CRP complications
include transfusion, deep ulceration or fistula, stricture, and refractory perianal pain
Measured: 3 years
endoscopic score
Score of Vienna Rectoscopy Score (VRS)
Measured: 1 year
endoscopic score
Score of Rectal Telangiectasia Density
Measured: 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.
Measured: 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
Measured: baseline, 6 months, 1 year, 2 years, 3 years
Rate of colostomy complications
such as prolapse, edema, necrosis, retraction.
Measured: baseline, 6 months, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Jul 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Wang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Lei Wang, Professor, Principal investigator, Sixth Affiliated Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397901
- Sponsor's protocol ID
- Colostomy-001
- Status last verified
- Jul 2019
- First submitted
- 26 Dec 2017
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is private information
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.
PubMed 27350738Ma 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.
PubMed 25834325
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03397901
- Acronym / sponsor ID
- Colostomy-001
- Conditions
- Chronic Radiation Proctitis, Rectal Bleeding, Colostomy Stoma, Anemia
- Keywords
- chronic radiation proctitis, rectal bleeding, transverse colostomy, refractory, moderate to severe anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transverse colostomy | Experimental | Procedure: Transverse colostomyDiverting 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse colostomyTransverse double-cavity colostomy | Procedure or surgery | transverse colostomy |
Primary outcome
remission rate of rectal bleeding after colostomy
Time frame: 6 mon after colostomy
retcal bleeding is assessed by soma scores
8 secondary outcomes
Remission rate of rectal bleeding
Time frame: 1 year, 2years, 3 years
Rate of colostomy closure
Time frame: 1 years, 1.5 years, 2 years
Rate of severe CRP complications
Time frame: 3 years
endoscopic score
Time frame: 1 year
endoscopic score
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Quality of life by EORTC scores
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Anorectal function outcomes
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Rate of colostomy complications
Time frame: baseline, 6 months, 1 year, 2 years, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 27350738Yuan 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.
- Background: PubMed 25834325Ma 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.
- Individual participant dataSharing planned: No. IPD is private information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Wang, Professor principal investigator
Sixth Affiliated Hospital of Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse colostomy in people with Chronic Radiation Proctitis and Rectal Bleeding, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Wang, Professor,MD (00861392618055, wangl9@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission rate of rectal bleeding after colostomy (time frame: 6 mon after colostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.