Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

June 7, 2012 updated by: Erasmo Spaziani, University of Roma La Sapienza

Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up

The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • grade III and IV hemorrhoids requiring hemorrhoidectomy.

Exclusion Criteria:

  • first and second degree hemorrhoids
  • patients with firm and fibrotic external irreducible haemorrhoids
  • thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment
  • history of inflammatory bowel disease; history of colon, rectal or anal cancer
  • inability to give informed consent
  • age < 18 years
  • pregnant women.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Haemorrhoidal dearterialisation
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.
Procedure: Transanal haemorrhoidal dearterialisation
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy
Active Comparator: Stapler haemorrhoidopexy
Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)
Procedure: Stapler haemorrhoidopexy
Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 42 months
A telephone interview with a structured questionnaire at a median follow-up of 42 months.
42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 hr
Pain score 24 hr after operation
24 hr
Complications
Time Frame: One month
Intra and postoperative complication within 30 days.
One month

Collaborators and Investigators

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

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Pierino Lucarelli, MD, FRCS

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

October 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URomLS1

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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