Stapled TransAnal Rectal Resection (STARR): Clinical and... | NCT00587080

Studies
Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome

NCT00587080

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jan 7, 2008Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Obstructed Defecation Syndrome (ODS)

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Jul 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2007

Last Update Posted Date

Jan 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and radiological outcome as assessed by closed-configuration MR defecography

Secondary Outcomes

Measure	Description	Time Frame
Morbidity and Mortality after STARR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years
clinical signs of ODS with prior not effective conservative treatment
anterior rectoceles and/or intussusceptions in MR-defecography

Exclusion Criteria:

< 18 years
fixed enteroceles
severe fecal incontinence
external rectal prolapse
anismus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with ODS and diagnosis of rectal redundancy (intussusception/rectoceles) in MR defecography

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Dindo, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Clinic for Visceral and Transplantation Surgery		Zurich	Canton of Zurich	8091	Switzerland