Obstructive Defecation SyndromeNCT00655382
Dynamic MRI Evaluation Post Operative Stapled Trans Anal Rectal Resection (STARR) Procedure
An observational study of Obstructive Defecation Syndrome and Outlet Obstruction, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Obstructive Defecation Syndrome, Outlet Obstruction
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had STARR procedure performed at Mayo Clinic - Jacksonville
Who may be able to join
- Patients willing to have a follow-up with a dynamic pelvic MRI and complete an obstructive defecation score (ODS) at 6 month post STARR procedure at Mayo Clinic - Jacksonville
Who cannot join
- Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic MRI Evaluation Post op STARR Procedure
The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.
Read the detailed description
The use of dynamic pelvic MRI has greatly impacted our preoperative evaluation of pelvic floor disorders, both anatomically and functionally. The STARR procedure is a new approved procedure for patients with obstructive defecation, who have failed conservative therapy of medications and aggressive pelvic floor retraining. Most patients have also been screened for colonic transit problems. The traditional study for evaluating these patients was defecating proctograms. With the advent of the dynamic pelvic MRI, we are now beginning to understand the interaction of the entire pelvic structure in the complex act of defecation. This study is providing us a different view of the pelvic structures to better understand the pathophysiology of this disorder. The defecating proctogram, though informative in certain cases, lacks information outside the rectum. We wish to evaluate and compare our preoperative dynamic pelvic MRI with a six month dynamic pelvic MRI in 10 patients. We also will compare pre and post op obstructive defecation scores (ODS). We expect this small sample to direct us to a much more pointed evaluation of this disorder.
- Keywords
- dynamic pelvic mri, dynamic mri, STARR procedure, STARR, ODS, obstructive defecation syndrome, outlet obstruction, obstructed defecation, stapled trans anal rectal resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Defecation SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Investigators
- Paul D. Pettit, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655382
- Sponsor's protocol ID
- 06-004724
- Status last verified
- May 2010
- First submitted
- 3 Apr 2008
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic MRI Evaluation Post op STARR Procedure
- ClinicalTrials.gov ID
- NCT00655382
- Acronym / sponsor ID
- 06-004724
- Keywords
- dynamic pelvic mri, dynamic mri, STARR procedure, STARR, ODS, obstructive defecation syndrome, outlet obstruction, obstructed defecation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Oct 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Apr 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.
The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.
Detailed description
The use of dynamic pelvic MRI has greatly impacted our preoperative evaluation of pelvic floor disorders, both anatomically and functionally. The STARR procedure is a new approved procedure for patients with obstructive defecation, who have failed conservative therapy of medications and aggressive pelvic floor retraining. Most patients have also been screened for colonic transit problems. The traditional study for evaluating these patients was defecating proctograms. With the advent of the dynamic pelvic MRI, we are now beginning to understand the interaction of the entire pelvic structure in the complex act of defecation. This study is providing us a different view of the pelvic structures to better understand the pathophysiology of this disorder. The defecating proctogram, though informative in certain cases, lacks information outside the rectum. We wish to evaluate and compare our preoperative dynamic pelvic MRI with a six month dynamic pelvic MRI in 10 patients. We also will compare pre and post op obstructive defecation scores (ODS). We expect this small sample to direct us to a much more pointed evaluation of this disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had STARR procedure performed at Mayo Clinic - Jacksonville
Key inclusion criteria (1 listed)
- Patients willing to have a follow-up with a dynamic pelvic MRI and complete an obstructive defecation score (ODS) at 6 month post STARR procedure at Mayo Clinic - Jacksonville
Key exclusion criteria (1 listed)
- Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI
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
Not reported in the source record.
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 21 May 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.
Paul D. Pettit, M.D. principal investigator
Mayo Clinic
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 Obstructive Defecation Syndrome and Outlet Obstruction, run by Mayo Clinic at 1 site in United States.
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 1 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 21 May 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 United States. 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.
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 21 May 2010.