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CompletedNCT00655382Updated May 21, 2010

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

An observational study in Obstructive Defecation Syndrome and Outlet Obstruction, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-05-21.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 90 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Defecation Syndrome
  • Outlet Obstruction

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Keywords

  • dynamic pelvic mri
  • dynamic mri
  • STARR procedure
  • STARR
  • ODS
  • obstructive defecation syndrome
  • outlet obstruction
  • obstructed defecation
  • stapled trans anal rectal resection
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 10 is below the median of 102 across 2,209 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who had STARR procedure performed at Mayo Clinic - Jacksonville

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

Exclusion Criteria:

  • Patients with medical devices/implants or who cannot have follow-up dynamic pelvic MRI
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
06

Study locations

1 site
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00655382
Lead sponsor
Mayo Clinic
Collaborators
Ethicon Endo-Surgery
First posted
Apr 9, 2008
Start date
Oct 2007
Primary completion
May 2010
Completion
May 2010
Last update
May 21, 2010

Study contacts

Paul D. Pettit, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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