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

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ClinicalTrials.gov Identifier: NCT01301209
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Medical University of Vienna

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.

Condition or disease
Haemorrhoids

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Group/Cohort
treatment
patients undergoing treatment




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

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

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 Posted: February 23, 2011    Key Record Dates
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