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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301209
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose
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.

Condition Phase
Haemorrhoids Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Estimated Enrollment: 200
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
treatment
patients undergoing treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with haemorrhoids stage III/IV
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301209


Locations
Austria
Dept. of Surgery, Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sebastian Roka, MD medical university Vienna
  More Information

Responsible Party: Sebastian Roka/MD, Dept. of General Surgery, Medical University Vienna
ClinicalTrials.gov Identifier: NCT01301209     History of Changes
Other Study ID Numbers: 078/2006
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: June 2006

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases