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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00655382
Collaborator
Ethicon Endo-Surgery (Industry)
10
1
31
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dynamic MRI Evaluation Post op STARR Procedure
    Study Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    May 1, 2010
    Actual Study Completion Date :
    May 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00655382
      Other Study ID Numbers:
      • 06-004724
      First Posted:
      Apr 9, 2008
      Last Update Posted:
      May 21, 2010
      Last Verified:
      May 1, 2010

      Study Results

      No Results Posted as of May 21, 2010