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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Defecation Syndrome; Outlet Obstruction

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who had STARR procedure performed at Mayo Clinic - Jacksonville

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Paul D. Pettit, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2010
• Last Update Submitted That Met QC Criteria: May 20, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: STARR; obstructed defecation; dynamic pelvic mri; dynamic mri; STARR procedure; ODS; obstructive defecation syndrome; outlet obstruction; stapled trans anal rectal resection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 06-004724