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

This study is currently recruiting participants.
Verified by Mayo Clinic, April 2008

Sponsors and Collaborators: Mayo Clinic
Ethicon Endo-Surgery
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00655382
  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

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Dynamic MRI Evaluation Post op STARR Procedure

Further study details as provided by Mayo Clinic:

Biospecimen Retention:   None Retained

Biospecimen Description:

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)

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
Ages Eligible for Study:   18 Years to 90 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655382

Contacts
Contact: Yvette Phillips     904-953-2255    

Locations
United States, Florida
Mayo Clinic     Recruiting
      Jacksonville, Florida, United States, 32224
      Contact: Yvette Phillips     904-953-2255        
      Principal Investigator: Paul D. Pettit, M.D.            

Sponsors and Collaborators
Mayo Clinic
Ethicon Endo-Surgery

Investigators
Principal Investigator:     Paul D. Pettit, M.D.     Mayo Clinic    
  More Information


Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site
 

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

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

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 10, 2008




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