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Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Scientific Institute San Raffaele
ClinicalTrials.gov Identifier:
NCT01263431
First received: December 17, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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: Milligan and Morgan hemorrhoidectomy
Procedure: doppler-guided transanal haemorrhoidal dearterialisation and anopexy
 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:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

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 ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hemorrhoidectomy Procedure: Milligan and Morgan hemorrhoidectomy
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
Experimental: Hemorrhoidal dearterialization Procedure: doppler-guided transanal haemorrhoidal dearterialisation and anopexy
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263431

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

No publications provided

Responsible Party: Paola De Nardi, San Raffaele Scientific Institute
ClinicalTrials.gov Identifier: NCT01263431     History of Changes
Other Study ID Numbers: Emorroidi grado 3
Study First Received: December 17, 2010
Last Updated: July 20, 2011
Health Authority: Italy: National Institute of Health

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

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 21, 2013