Colitis, UlcerativeNCT00922103
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
A study testing Ileal Neo Rectal Anastomosis and Ileal Pouch Anal Anastomosis in people with Colitis, Ulcerative and Surgery, run by Elisabeth-TweeSteden Ziekenhuis at 2 sites in Netherlands.
Trial summary
For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Colitis, Ulcerative, Surgery
- What is being tested?
- Ileal Neo Rectal Anastomosis and Ileal Pouch Anal Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2005to Jul 2010
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- UC patients with INRA procedure
- Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
- Written informed consent
Who cannot join
- Pregnancy
- Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
- Psychiatric disease or inability to assess follow up
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Centre St Radboud
Nijmegen, Gelderland, 6500 HB
St Elisabeth Hospital
Tilburg, North Brabant, 5022 GC
About this study
Official title: A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)
For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.
Read the detailed description
This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.
The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.
The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.
- Conditions
- Colitis, Ulcerative, Surgery
- Being tested
- Ileal Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis
- Keywords
- Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal Neo Rectal AnastomosisProcedure or surgery
Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis
Ileal Pouch Anal AnastomosisProcedure or surgery
Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis
| Study group | Role | What they receive |
|---|---|---|
| INRA | Experimental | Patients treated for medical refractory Ulcerative Colitis Receives: Procedure: Ileal Neo Rectal Anastomosis |
| IPAA | Active comparator | Patients treated for medical refractory Ulcerative Colitis Receives: Procedure: Ileal Pouch Anal Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Quality of life and Health Status
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Secondary outcomes (4)
histo-pathologic results
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
endoscopic results
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
morbidity and mortality
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
ano-rectal physiology
Measured: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Investigators
- JT Heikens, MD, Principal investigator, St Elisabeth Hospital, Tilburg, The NetherlandsD de Jong, MD, PhD, Study chair, University Medical Centre St Radboud, Nijmegen, The NetherlandsJLJM Teepen, MD, PhD, Study chair, St Elisabeth Hospital, Tilburg, The NetherlandsJHJM van Krieken, MD, PhD, Study chair, University Medical Centre St Radboud, The NetherlandsHG Gooszen, MD, PhD, Study chair, University Medical Centre St Radboud, Nijmegen, The NetherlandsJ de Vries, Md, PhD, Study chair, St Elisabeth Hospital, Tilburg, The NetherlandsCJHM van Laarhoven, MD, PhD, Study director, University Medical Centre St Radboud, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922103
- Sponsor's protocol ID
- 0426
- Other IDs
- AMO nr. 04/074
- Status last verified
- Sep 2010
- First submitted
- 12 Jun 2009
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT00922103
- Acronym / sponsor ID
- 0426
- Conditions
- Colitis, Ulcerative, Surgery
- Keywords
- Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elisabeth-TweeSteden ZiekenhuisUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Jun 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.
For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.
Detailed description
This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.
The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.
The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INRA | Experimental | Procedure: Ileal Neo Rectal AnastomosisPatients treated for medical refractory Ulcerative Colitis |
| IPAA | Active comparator | Procedure: Ileal Pouch Anal AnastomosisPatients treated for medical refractory Ulcerative Colitis |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- UC patients with INRA procedure
- Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
- Psychiatric disease or inability to assess follow up
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 |
|---|---|---|
| Ileal Neo Rectal AnastomosisComparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis | Procedure or surgery | INRA |
| Ileal Pouch Anal AnastomosisComparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis | Procedure or surgery | IPAA |
Primary outcome
functional outcome
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Quality of life and Health Status
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
4 secondary outcomes
histo-pathologic results
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
endoscopic results
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
morbidity and mortality
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
ano-rectal physiology
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
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 13 Sep 2010.
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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.
JT Heikens, MD principal investigator
St Elisabeth Hospital, Tilburg, The Netherlands
D de Jong, MD, PhD study chair
University Medical Centre St Radboud, Nijmegen, The Netherlands
JLJM Teepen, MD, PhD study chair
St Elisabeth Hospital, Tilburg, The Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal Neo Rectal Anastomosis and Ileal Pouch Anal Anastomosis in people with Colitis, Ulcerative and Surgery, run by Elisabeth-TweeSteden Ziekenhuis at 2 sites in Netherlands.
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 3 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 13 Sep 2010. 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 Netherlands. 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 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?
functional outcome (time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards). The study lists 2 primary outcomes in all. 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 13 Sep 2010.