SurgeryPhase 4NCT00521872
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
A Phase 4 study testing STARR Operation in people with Surgery and Constipation, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction. Trial with surgical intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Constipation
- What is being tested?
- STARR Operation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2004to Oct 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients at our institution treated with the STARR operation
Who cannot join
- Age under 18,
- Chronic or acute inflammatory disease of the bowel or rectum
Trial locations and contacts
1 site in 1 country.
About this study
This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.
- Trial with surgical intervention
- Conditions
- Surgery, Constipation
- Being tested
- STARR Operation
- Keywords
- surgery (STARR operation)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARR OperationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startApr 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521872
- Sponsor's protocol ID
- 33-2006
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
- ClinicalTrials.gov ID
- NCT00521872
- Acronym / sponsor ID
- 33-2006
- Conditions
- Surgery, Constipation
- Keywords
- surgery (STARR operation)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Aug 2007 (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.
This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.
- Trial with surgical intervention
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients at our institution treated with the STARR operation
Key exclusion criteria (2 listed)
- Age under 18,
- Chronic or acute inflammatory disease of the bowel or rectum
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 |
|---|---|---|
| STARR Operation | Procedure or surgery | – |
Primary outcome
Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
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 26 Jun 2008.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing STARR Operation in people with Surgery and Constipation, 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 1 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: finished, as of the sponsor's last update on 26 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles. 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 26 Jun 2008.