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Dynamic MRI Evaluation Post Operative Stapled Trans Anal Rectal Resection (STARR) Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655382
First Posted: April 9, 2008
Last Update Posted: May 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Mayo Clinic
  Purpose
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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic MRI Evaluation Post op STARR Procedure

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had STARR procedure performed at Mayo Clinic - Jacksonville
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655382


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Ethicon Endo-Surgery
Investigators
Principal Investigator: Paul D. Pettit, M.D. Mayo Clinic
  More Information

Additional Information:
Responsible Party: Paul D. Pettit, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00655382     History of Changes
Other Study ID Numbers: 06-004724
First Submitted: April 3, 2008
First Posted: April 9, 2008
Last Update Posted: May 21, 2010
Last Verified: May 2010

Keywords provided by Mayo Clinic:
dynamic pelvic mri
dynamic mri
STARR procedure
STARR
ODS
obstructive defecation syndrome
outlet obstruction
obstructed defecation
stapled trans anal rectal resection