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

Haemorrhoids Clinical Trial

Official title:

Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301209
• Other study ID #: 078/2006
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2011
• Last updated: February 22, 2011
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2006
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemorrhoids
• Hemorrhoids

Locations

Country	Name	City	State
Austria	Dept. of Surgery, Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria,