Ulcerative ColitisCR-IPAANCT01111708
Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU)
A study testing Close Rectal Dissection - IPAA in people with Ulcerative Colitis, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Close Rectal Dissection - IPAA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Apr 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- UC patients with the CRD procedure with written informed consent.
- Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.
Who cannot join
- Pregnancy
- Malignancy
- Psychiatric disease or inability to assess follow-up
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medical Centre St. Radboud
Nijmegen, Gelderland, 6500HB
Sharonne de Zeeuw, Drs, 0031-24-3616421, s.dezeeuw@chir.umcn.nl
Sharonne de Zeeuw, Drs
About this study
Official title: Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa Compared to the Ileo Neo Rectal Anastomosis and the Ileo Pouch Anal Anastomosis
The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).
Read the detailed description
Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.
- Conditions
- Ulcerative Colitis
- Being tested
- Close Rectal Dissection - IPAA
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close Rectal Dissection - IPAAProcedure or surgery
Also called INRA, IPAA, restorative surgery
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
| Study group | Role | What they receive |
|---|---|---|
| Close Rectal-Ileo Pouch Anal Anastomosis | Experimental | Not described Receives: Procedure: Close Rectal Dissection - IPAA |
| Conventional Ileo Pouch Anal Anastomosis | Active comparator | Not described Receives: Procedure: Close Rectal Dissection - IPAA |
| Ileo Neo Rectal Anastomosis | Active comparator | Not described Receives: Procedure: Close Rectal Dissection - IPAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups.
Measured: 1 year
Secondary outcomes (1)
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Investigators
- Kees v Laarhoven, prof. dr., Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111708
- Sponsor's protocol ID
- Close Rectal - IPAA
- Acronym
- CR-IPAA
- Status last verified
- Jan 2010
- First submitted
- 26 Apr 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa Compared to the Ileo Neo Rectal Anastomosis and the Ileo Pouch Anal Anastomosis
- ClinicalTrials.gov ID
- NCT01111708
- Acronym / sponsor ID
- CR-IPAA / Close Rectal - IPAA
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 27 Apr 2010 (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.
The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).
Detailed description
Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Close Rectal-Ileo Pouch Anal Anastomosis | Experimental | Procedure: Close Rectal Dissection - IPAA |
| Conventional Ileo Pouch Anal Anastomosis | Active comparator | Procedure: Close Rectal Dissection - IPAA |
| Ileo Neo Rectal Anastomosis | Active comparator | Procedure: Close Rectal Dissection - IPAA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- UC patients with the CRD procedure with written informed consent.
- Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.
Key exclusion criteria (3 listed)
- Pregnancy
- Malignancy
- 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 |
|---|---|---|
| Close Rectal Dissection - IPAAAlso: INRA, IPAA, restorative surgeryComparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis | Procedure or surgery | Close Rectal-Ileo Pouch Anal Anastomosis, Conventional Ileo Pouch Anal Anastomosis, Ileo Neo Rectal Anastomosis |
Primary outcome
To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups.
Time frame: 1 year
1 secondary outcome
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
Kees v Laarhoven, prof. dr. study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Close Rectal Dissection - IPAA in people with Ulcerative Colitis, run by University Medical Center Nijmegen at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharonne de Zeeuw, Drs (+31-24-3616421, s.dezeeuw@chir.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups. (time frame: 1 year). 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 27 Apr 2010.