Obstructed Defecation Syndrome (ODS)NCT00587080
Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome
An observational study of Obstructed Defecation Syndrome (ODS), run by University of Zurich at 1 site in Switzerland.
Trial summary
To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructed Defecation Syndrome (ODS)
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2004to Aug 2007
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ODS and diagnosis of rectal redundancy (intussusception/rectoceles) in MR defecography
Who may be able to join
- > 18 years
- clinical signs of ODS with prior not effective conservative treatment
- anterior rectoceles and/or intussusceptions in MR-defecography
Who cannot join
- < 18 years
- fixed enteroceles
- severe fecal incontinence
- external rectal prolapse
- anismus
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital, Clinic for Visceral and Transplantation Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Stapled TransAnal Rectal Resection (STARR): Correlation Between Clinical and Radiological Outcome
To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)
- Conditions
- Obstructed Defecation Syndrome (ODS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiological outcome as assessed by closed-configuration MR defecography
Secondary outcomes (1)
Morbidity and Mortality after STARR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructed Defecation Syndrome (ODS)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Dindo, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587080
- Sponsor's protocol ID
- StV 33-2006
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapled TransAnal Rectal Resection (STARR): Correlation Between Clinical and Radiological Outcome
- ClinicalTrials.gov ID
- NCT00587080
- Acronym / sponsor ID
- StV 33-2006
- Conditions
- Obstructed Defecation Syndrome (ODS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Jan 2008 (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.
To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ODS and diagnosis of rectal redundancy (intussusception/rectoceles) in MR defecography
Key inclusion criteria (3 listed)
- > 18 years
- clinical signs of ODS with prior not effective conservative treatment
- anterior rectoceles and/or intussusceptions in MR-defecography
Key exclusion criteria (5 listed)
- < 18 years
- fixed enteroceles
- severe fecal incontinence
- external rectal prolapse
- anismus
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
Clinical and radiological outcome as assessed by closed-configuration MR defecography
1 secondary outcome
Morbidity and Mortality after STARR
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 7 Jan 2008.
Related trials for Obstructed Defecation Syndrome (ODS)
Not yet recruiting
Clinical Evaluation of the Femiset Device for Perineal Descent in Women
Perineal Descent, Obstructed Defecation Syndrome (ODS)
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.
Daniel Dindo, MD principal investigator
University of Zurich
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 Obstructed Defecation Syndrome (ODS), run by University of Zurich at 1 site in Switzerland.
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 5 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 7 Jan 2008. 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 Switzerland. 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?
Clinical and radiological outcome as assessed by closed-configuration MR defecography. 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 7 Jan 2008.