NCT00521872

Brief Summary

This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.

  • Trial with surgical intervention

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4 surgery

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

April 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 26, 2008

Status Verified

August 1, 2007

First QC Date

August 27, 2007

Last Update Submit

June 25, 2008

Conditions

SurgeryConstipation

Keywords

surgery (STARR operation)

Outcome Measures

Primary Outcomes (1)

  • Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles

Interventions

STARR OperationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients at our institution treated with the STARR operation

You may not qualify if:

  • Age under 18,
  • Chronic or acute inflammatory disease of the bowel or rectum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversitätsSpital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Study Start

April 1, 2004

Study Completion

October 1, 2007

Last Updated

June 26, 2008

Record last verified: 2007-08

Locations

CH(1)