Ulcerative ColitisNCT01798953
Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis
An observational study of Ulcerative Colitis and Primary Sclerosing Cholangitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients… Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Ulcerative Colitis, Primary Sclerosing Cholangitis, Pouchitis
- How many people
- 175 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Nov 2013
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
Who may be able to join
- UC
- PSC
- IPAA
- IRA
Who cannot join
- non-UC
- non-PSC
- no consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Gothenburg, Göteborg, 41685
About this study
Official title: Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis for Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis?
Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.
Read the detailed description
Primary sclerosing cholangitis (PSC) is characterised by inflammation and fibrosis of the biliary tree and the condition can lead to end-stage liver disease. PSC is strongly associated with inflammatory bowel disease (IBD), with a prevalence of IBD in PSC as high as 60-84 % in Northern Europe and North America. The majority of patients with IBD and PSC have ulcerative colitis (UC).
Considering all patients with UC, around 30% will ultimately require surgery; the most common indications are acute colitis, chronic refractory disease or colorectal dysplasia. The standard procedure is proctocolectomy and ileal pouch-anal anastomosis (IPAA). However, ileo-rectal anastomosis (IRA) or conventional ileostomy are options. The prognosis after surgery is generally considered good.
Previous studies have shown that the course of colitis in patients with UC/PSC is different from that of patients with UC-only.
In a patient with UC, several aspects have to be considered at counselling before surgery. However, in many aspects, the literature is substantial for patients with UC-only (for example function and quality of life after IPAA) and key information can be safely provided. Conversely, patients with UC/PSC that require colectomy are rare and as a consequence, data on most aspects is sparse (18-20).
The aim of the study was to assess outcome after surgery (IPAA or IRA) in patients with UC/PSC. Focus was on pouch/rectal function, pouchitis, surgical complications and failure. Patients with UC-only were employed as controls.
- Keywords
- Ulcerative Colitis, Primary Sclerosing Cholangitis, Ileal pouch-anal anastomosis, Ileorectal anastomosis, Surgical outcome, Functional outcome, Failure
- Medical subject headings
- Colitis, Ulcerative, Cholangitis, Sclerosing, Pouchitis
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 |
|---|---|---|
| UC/PSC with IPAA | Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis | |
| UC with IPAA | Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis. | |
| UC/PSC with IRA | Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis. | |
| UC with IRA | Patients with ulcerative colitis reconstructed with ileorectal anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Measured: Up to six months
Secondary outcomes (1)
Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Measured: Up to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionNov 2013
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.
- More trials run by Sahlgrenska University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Block, Sahlgrenska University Hospital
- Investigators
- Lars G Börjesson, Ass Prof, Principal investigator, Department of Surgery, Sahlgrenska, Göteborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798953
- Sponsor's protocol ID
- 326-10
- Status last verified
- Apr 2016
- First submitted
- 19 Feb 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: PubMed
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ileal Pouch-anal Anastomosis or Ileo-rectal Anastomosis for Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis?
- ClinicalTrials.gov ID
- NCT01798953
- Acronym / sponsor ID
- 326-10
- Keywords
- Ulcerative Colitis, Primary Sclerosing Cholangitis, Ileal pouch-anal anastomosis, Ileorectal anastomosis, Surgical outcome, Functional outcome, Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Feb 2013 (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.
Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.
Detailed description
Primary sclerosing cholangitis (PSC) is characterised by inflammation and fibrosis of the biliary tree and the condition can lead to end-stage liver disease. PSC is strongly associated with inflammatory bowel disease (IBD), with a prevalence of IBD in PSC as high as 60-84 % in Northern Europe and North America. The majority of patients with IBD and PSC have ulcerative colitis (UC).
Considering all patients with UC, around 30% will ultimately require surgery; the most common indications are acute colitis, chronic refractory disease or colorectal dysplasia. The standard procedure is proctocolectomy and ileal pouch-anal anastomosis (IPAA). However, ileo-rectal anastomosis (IRA) or conventional ileostomy are options. The prognosis after surgery is generally considered good.
Previous studies have shown that the course of colitis in patients with UC/PSC is different from that of patients with UC-only.
In a patient with UC, several aspects have to be considered at counselling before surgery. However, in many aspects, the literature is substantial for patients with UC-only (for example function and quality of life after IPAA) and key information can be safely provided. Conversely, patients with UC/PSC that require colectomy are rare and as a consequence, data on most aspects is sparse (18-20).
The aim of the study was to assess outcome after surgery (IPAA or IRA) in patients with UC/PSC. Focus was on pouch/rectal function, pouchitis, surgical complications and failure. Patients with UC-only were employed as controls.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UC/PSC with IPAA | – | –Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileal pouch-anal anastomosis |
| UC with IPAA | – | –Patients with ulcerative colitis reconstructed with ileal pouch-anal anastomosis. |
| UC/PSC with IRA | – | –Patients with ulcerative colitis and primary sclerosing cholangitis reconstructed with ileorectal anastomosis. |
| UC with IRA | – | –Patients with ulcerative colitis reconstructed with ileorectal anastomosis. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
Key inclusion criteria (4 listed)
- UC
- PSC
- IPAA
- IRA
Key exclusion criteria (3 listed)
- non-UC
- non-PSC
- no consent
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
Functional outcome after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Time frame: Up to six months
1 secondary outcome
Complications after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only.
Time frame: Up to six months.
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 19 Apr 2016.
- Individual participant dataSharing planned: Yes. PubMed
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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.
Lars G Börjesson, Ass Prof principal investigator
Department of Surgery, Sahlgrenska, Göteborg
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 Ulcerative Colitis and Primary Sclerosing Cholangitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 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 19 Apr 2016. 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 Sweden. 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 after reconstructive surgery with IPAA/IRA in patients with UC/PSC vs patients with UC only. (time frame: Up to six months). 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 19 Apr 2016.