Recto-Anal-Repair in the Treatment of Advanced Haemorrhoi... | NCT01301209

Studies
Recto-Anal-Repair in the Treatment of Advanced Haemorrhoidal Disease

NCT01301209

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Feb 23, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Haemorrhoids

Interventions

Not provided

Countries

Austria

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

Jun 2006

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 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

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

Feb 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

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

Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease.

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

200Estimated

Label	Type	Description	Intervention Names
treatment		patients undergoing treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage III or IV hemorrhoidal disease (Appendix A)
Patient age 18-80 years old
Patient fit for general or local anesthesia
No prior surgical treatment for hemorrhoidal disease
No prior surgical treatment for anorectal sepsis
Signed informed consent

Exclusion Criteria:

Stage I or II hemorrhoidal disease (Appendix A)
Patient unfit for surgery
Clotting disorders
Anal or colorectal malignancy
Secondary hemorrhoidal disease
Pregnancy
Unwilling or unable to sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with haemorrhoids stage III/IV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Roka, MD	Medical University Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Surgery, Medical University Vienna		Vienna	State of Vienna	1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided