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Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

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ClinicalTrials.gov Identifier: NCT01263431
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : January 22, 2015
Information provided by (Responsible Party):
Paola De Nardi, Scientific Institute San Raffaele

Brief Summary:
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 or disease Intervention/treatment Phase
Third Degree Hemorrhoids Procedure: Hemorrhoidectomy Procedure: Hemorrhoidal dearterialization Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : April 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. postoperative morbidity [ Time Frame: 30 days ]
  2. resumption of working activity [ Time Frame: 30 days ]
  3. patient's satisfaction [ Time Frame: 30 days ]
  4. Relapse [ Time Frame: 24 months ]

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

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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paola De Nardi, MD, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT01263431     History of Changes
Other Study ID Numbers: Emorroidi grado 3
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

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

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