Ileal Pouch-Anal AnastomosisIPAANCT01026480
Ileal Pouch-Anal Anastomosis Registry
An observational study of Ileal Pouch-Anal Anastomosis, run by Boston Medical Center at 1 site in United States.
Trial summary
Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ileal Pouch-Anal Anastomosis
- How many people
- 936 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 16 Mar 2017
- 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: Patients scheduled for, or who have undergone, ileal pouch-anal anastomosis (IPAA) procedure and have been treated by a Center for Digestive Disorders physician at Boston Medical Center
Who may be able to join
- Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
- Treated by a Center for Digestive Disorders physician
- Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure
Who cannot join
- Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
- Patients who are currently incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ileal Pouch-Anal Anastomosis (IPAA) Registry
Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.
Read the detailed description
In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.
- Conditions
- Ileal Pouch-Anal Anastomosis
- Keywords
- Ileal Pouch Anal Anastomosis, IPAA, Pull through, IBD, Ulcerative colitis, Familial adenomatous polyposis, FAP, Hereditary nonpolyposis colorectal cancer, HNPCC
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli, Colorectal Neoplasms, Hereditary Nonpolyposis
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 |
|---|---|---|
| IPAA Patients | Patients who have had their IPAA procedures performed by Dr. Becker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch status: functional pouch or non-functional pouch (diverted or excised)
Participants will be queried once per year as to the status of their intestinal pouch. Patients will have either a functional pouch or a non-functional pouch. A pouch will be considered functional if patient is not temporarily or permanently diverted to an ileostomy.
Measured: Once per year for duration of the study
Secondary outcomes (2)
Quality of life
Participants will be queried once per year as to their quality of life using the IBDQ-10.
Measured: Once per year for duration of the study
Health status
Participants will be queried once per year regarding health issues with pouch such as pouchitis, stricture and fistula. Participants will also be asked about presence of co-morbidities such as hypertension, diabetes and arthritis.
Measured: Once per year for duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startNov 2009
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Why it stopped: Researchers leading this study have left BMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileal Pouch-Anal AnastomosisStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis Farraye, MD, Boston Medical Center
- Investigators
- James M Becker, MD, Principal investigator, Boston Medical CenterFrancis A Farraye, MD, Study director, Boston Medical CenterArthur F Stucchi, PhD, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026480
- Sponsor's protocol ID
- H-28518
- Acronym
- IPAA
- Status last verified
- Mar 2017
- First submitted
- 25 Nov 2009
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ileal Pouch-Anal Anastomosis (IPAA) Registry
- ClinicalTrials.gov ID
- NCT01026480
- Acronym / sponsor ID
- IPAA / H-28518
- Conditions
- Ileal Pouch-Anal Anastomosis
- Keywords
- Ileal Pouch Anal Anastomosis, IPAA, Pull through, IBD, Ulcerative colitis, Familial adenomatous polyposis, FAP, Hereditary nonpolyposis colorectal cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Researchers leading this study have left BMC
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 4 Dec 2009 (estimated)
- 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.
Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.
Detailed description
In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPAA Patients | – | –Patients who have had their IPAA procedures performed by Dr. Becker |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for, or who have undergone, ileal pouch-anal anastomosis (IPAA) procedure and have been treated by a Center for Digestive Disorders physician at Boston Medical Center
Key inclusion criteria (3 listed)
- Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
- Treated by a Center for Digestive Disorders physician
- Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure
Key exclusion criteria (2 listed)
- Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
- Patients who are currently incarcerated
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
Pouch status: functional pouch or non-functional pouch (diverted or excised)
Time frame: Once per year for duration of the study
Participants will be queried once per year as to the status of their intestinal pouch. Patients will have either a functional pouch or a non-functional pouch. A pouch will be considered functional if patient is not temporarily or permanently diverted to an ileostomy.
2 secondary outcomes
Quality of life
Time frame: Once per year for duration of the study
Health status
Time frame: Once per year for duration of the study
Results and safety
The study was stopped early (reason given: Researchers leading this study have left BMC). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- IPAA Registry at Boston Medical CenterLink provided by the sponsor.
Related trials for Ileal Pouch-Anal Anastomosis
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Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
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Not yet recruitingPhase 4
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
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Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
Ileal Pouch
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.
James M Becker, MD principal investigator
Boston Medical Center
Francis A Farraye, MD study director
Boston Medical Center
Arthur F Stucchi, PhD study director
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileal Pouch-Anal Anastomosis, run by Boston Medical Center at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Researchers leading this study have left BMC). Results are not available in the source record.
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?
Pouch status: functional pouch or non-functional pouch (diverted or excised) (time frame: Once per year for duration of the study). 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 17 Mar 2017.