Ulcerative Colitis AcuteNCT03578692
Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)
An observational study of Ulcerative Colitis Acute and Surgery, run by Gao Tao.
Trial summary
Acute severe ulcerative colitis [ASUC] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis Acute, Surgery
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Apr 2018
- Phase
- Observational
- 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
Study population: All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.
Who may be able to join
- The inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.
Who cannot join
- Patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.
About this study
Official title: Clinical Value of Inflammation-related Indicators of Blood and Fecal Calprotectin in Predicting the Surgery Rate of Acute Severe Ulcerative Colitis
Acute severe ulcerative colitis [ASUC] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.
- Conditions
- Ulcerative Colitis Acute, Surgery
- Keywords
- acute severe ulcerative colitis, predictive indicator, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | The protocol for patients assigned to surgery group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed bad response to medicine (glucocorticoid for 5 days and rescue therapy for 3 days) were recommended and classified in the surgery group. Their baseline manifestations were collected and compared with the medical group, to exploit the baseline indicators with great sensitive and specificity predicting the high risk for surgery. | |
| Medical group | The protocol for patients assigned to medical group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed response to medicine (glucocorticoid for 5 days or rescue therapy for 3 days) were classified in the medical group. Their baseline manifestations were collected and compared with the surgery group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon operation
100% direct approximation of inevitable surgery
Measured: 30 days
Secondary outcomes (2)
No response to medical treatments
Medical treatments involve glucocorticoids, Immunosuppressant and biologicals for ulcerative colitis. The Oxford Index measured everyday, consisting of CRP and stool frequency, is used to evaluate the response to the treatment. If the Oxford Index does not reduce after 5-day medical treatment, this situation is deemed as no response to medical treatment
Measured: 5 days
30-day mortality
All-cause mortality within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jan 2012
- Primary completion31 Jan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao Tao, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578692
- Sponsor's protocol ID
- 2018NLY052
- Status last verified
- Jul 2018
- First submitted
- 7 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Inflammation-related Indicators of Blood and Fecal Calprotectin in Predicting the Surgery Rate of Acute Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03578692
- Acronym / sponsor ID
- 2018NLY052
- Conditions
- Ulcerative Colitis Acute, Surgery
- Keywords
- acute severe ulcerative colitis, predictive indicator, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Gao TaoUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Jul 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.
Acute severe ulcerative colitis [ASUC] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. Thus, we investigated whether biomarkers which could early predict the surgery risk of patients with ASUC on admission.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | – | –The protocol for patients assigned to surgery group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed bad response to medicine (glucocorticoid for 5 days and rescue therapy for 3 days) were recommended and classified in the surgery group. Their baseline manifestations were collected and compared with the medical group, to exploit the baseline indicators with great sensitive and specificity predicting the high risk for surgery. |
| Medical group | – | –The protocol for patients assigned to medical group was as follows. ASUC patients were admitted in, estimated their baseline situations and tested their blood and fecal indicators including PCT, IL-6 and FC on admission. All patients were treated according to the ECCO guideline 2012. Patients who showed response to medicine (glucocorticoid for 5 days or rescue therapy for 3 days) were classified in the medical group. Their baseline manifestations were collected and compared with the surgery group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All acute severe ulcerative colitis patients were admitted in hospital and prospectively followed during the study period.
Key inclusion criteria (1 listed)
- The inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis.
Key exclusion criteria (1 listed)
- Patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colon operation
Time frame: 30 days
100% direct approximation of inevitable surgery
2 secondary outcomes
No response to medical treatments
Time frame: 5 days
30-day mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis Acute and Surgery, run by Gao Tao.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon operation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018.