Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01615575
First received: June 4, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Haemorrhoids
Procedure: Transanal haemorrhoidal dearterialisation
Procedure: Stapler haemorrhoidopexy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 42 months ] [ Designated as safety issue: No ]
    A telephone interview with a structured questionnaire at a median follow-up of 42 months.


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
    Pain score 24 hr after operation

  • Complications [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    Intra and postoperative complication within 30 days.


Enrollment: 124
Study Start Date: October 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01615575

Locations
United Arab Emirates
The City Hospital
Dubai, United Arab Emirates, P O Box 505004
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Pierino Lucarelli, MD, FRCS
  More Information

No publications provided

Responsible Party: Erasmo Spaziani, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01615575     History of Changes
Other Study ID Numbers: URomLS1
Study First Received: June 4, 2012
Last Updated: June 7, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

ClinicalTrials.gov processed this record on September 29, 2014