NCT00655382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 21, 2010

Status Verified

May 1, 2010

Enrollment Period

2.6 years

First QC Date

April 3, 2008

Last Update Submit

May 20, 2010

Conditions

Obstructive Defecation SyndromeOutlet Obstruction

Keywords

dynamic pelvic mridynamic mriSTARR procedureSTARRODSobstructive defecation syndromeoutlet obstructionobstructed defecationstapled trans anal rectal resection

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had STARR procedure performed at Mayo Clinic - Jacksonville

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Paul D. Pettit, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 21, 2010

Record last verified: 2010-05

Locations

US(1)