Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

January 21, 2015 updated by: Paola De Nardi, Scientific Institute San Raffaele

Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • San Raffaele Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pain
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative morbidity
Time Frame: 30 days
30 days
Relapse
Time Frame: 24 months
24 months
patient's satisfaction
Time Frame: 30 days
30 days
resumption of working activity
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scientific Institute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emorroidi grado 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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