Ulcerative ColitisNCT03747068
The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.
An observational study of Ulcerative Colitis and Anti TNF Therapy, run by HaEmek Medical Center, Israel.
Trial summary
BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis, Anti TNF Therapy, Ileal Pouch Anal Anastomosis (IPAA)
- What is being tested?
- Anti-TNF Drug
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2009to 9 Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed. Patients with CD and those without adequate clinical records documenting the 30-day postoperative clinical outcomes were excluded
Who may be able to join
- all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .
Who cannot join
- Patients with CD
- Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .
About this study
Official title: Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis
BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery.
METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.
- Being tested
- Anti-TNF Drug
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF DrugDrug
| Study group | Role | What they receive |
|---|---|---|
| anti-TNF | UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery Receives: Drug: Anti-TNF Drug | |
| CONTROL GROUP | UC patients who were not exposed to anti-TNF therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery
Assesment of the degree of fibrosis in the lamina propria, the subbmucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.
Measured: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start9 Oct 2009
- Primary completion9 Oct 2015
- Study completion9 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, University of Toronto
- Responsible party
- Principal investigator, Eran Zittan, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747068
- Sponsor's protocol ID
- 09-0218-E
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis
- ClinicalTrials.gov ID
- NCT03747068
- Acronym / sponsor ID
- 09-0218-E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, University of Toronto
- Study start
- 9 Oct 2009 (actual)
- Primary completion
- 9 Oct 2015 (actual)
- Study completion
- 9 Oct 2015 (actual)
- First posted
- 20 Nov 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.
BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery.
METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-TNF | – | Drug: Anti-TNF DrugUC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery |
| CONTROL GROUP | – | –UC patients who were not exposed to anti-TNF therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed. Patients with CD and those without adequate clinical records documenting the 30-day postoperative clinical outcomes were excluded
Key inclusion criteria (1 listed)
- all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .
Key exclusion criteria (2 listed)
- Patients with CD
- Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .
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 |
|---|---|---|
| Anti-TNF Drug | Drug | anti-TNF |
Primary outcome
to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery
Time frame: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed
Assesment of the degree of fibrosis in the lamina propria, the subbmucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.
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 20 Nov 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 and Anti TNF Therapy, run by HaEmek Medical Center, Israel.
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 2 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 20 Nov 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?
to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery (time frame: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed). 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 20 Nov 2018.