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Sponsors and Collaborators: |
Mayo Clinic Ethicon Endo-Surgery |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00655382 |
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.
Condition |
Obstructive Defecation Syndrome Outlet Obstruction |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Dynamic MRI Evaluation Post op STARR Procedure |
Estimated Enrollment: | 10 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who had STARR procedure performed at Mayo Clinic - Jacksonville
Inclusion Criteria:
Exclusion Criteria:
Contact: Yvette Phillips | 904-953-2255 |
United States, Florida | |||||
Mayo Clinic | Recruiting | ||||
Jacksonville, Florida, United States, 32224 | |||||
Contact: Yvette Phillips 904-953-2255 | |||||
Principal Investigator: Paul D. Pettit, M.D. |
Mayo Clinic |
Ethicon Endo-Surgery |
Principal Investigator: | Paul D. Pettit, M.D. | Mayo Clinic |
Mayo Clinic Clinical Trials 
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Responsible Party: | Mayo Clinic ( Paul D. Pettit, M.D. ) |
Study ID Numbers: | 06-004724 |
First Received: | April 3, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00655382 |
Health Authority: | United States: Institutional Review Board |
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