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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01301209
First received: February 22, 2011
Last updated: NA
Last verified: June 2006
History: No changes posted
  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:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on May 23, 2013