Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

This study has been completed.
Information provided by (Responsible Party):
Paola De Nardi, Scientific Institute San Raffaele Identifier:
First received: December 17, 2010
Last updated: January 21, 2015
Last verified: January 2015
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction

Condition Intervention Phase
Third Degree Hemorrhoids
Procedure: Hemorrhoidectomy
Procedure: Hemorrhoidal dearterialization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy

Resource links provided by NLM:

Further study details as provided by Scientific Institute San Raffaele:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • resumption of working activity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hemorrhoidectomy
Excision of hemorrhoid cushions
Procedure: Hemorrhoidectomy
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
Experimental: Hemorrhoidal dearterialization
Ligation of therminbal branches oh hemorrhoid arteries
Procedure: Hemorrhoidal dearterialization
A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy

Detailed Description:
Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids

Exclusion Criteria:

  • Previous anal surgery or pelvic radiotherapy
  • Fecal incontinence or obstructed defecation
  • IBD, IBS
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Please refer to this study by its identifier: NCT01263431

San Raffaele Scientific Institute
Milano, Italy, 20132
Sponsors and Collaborators
Scientific Institute San Raffaele
Principal Investigator: Paola De Nardi, MD San Raffaele Scientific Institute
  More Information

Responsible Party: Paola De Nardi, MD, Scientific Institute San Raffaele Identifier: NCT01263431     History of Changes
Other Study ID Numbers: Emorroidi grado 3 
Study First Received: December 17, 2010
Last Updated: January 21, 2015
Health Authority: Italy: National Institute of Health

Keywords provided by Scientific Institute San Raffaele:
Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy

Additional relevant MeSH terms:
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases processed this record on May 02, 2016