NCT01301209

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 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

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

February 23, 2011

Status Verified

June 1, 2006

Enrollment Period

11 months

First QC Date

February 22, 2011

Last Update Submit

February 22, 2011

Conditions

Haemorrhoids

Study Arms (1)

treatment

patients undergoing treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with haemorrhoids stage III/IV

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sebastian Roka, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 23, 2011

Record last verified: 2006-06

Locations

AU(1)