We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615575
First Posted: June 8, 2012
Last Update Posted: June 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Erasmo Spaziani, University of Roma La Sapienza:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 42 months ]
    A telephone interview with a structured questionnaire at a median follow-up of 42 months.


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 24 hr ]
    Pain score 24 hr after operation

  • Complications [ Time Frame: One month ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Erasmo Spaziani, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01615575     History of Changes
Other Study ID Numbers: URomLS1
First Submitted: June 4, 2012
First Posted: June 8, 2012
Last Update Posted: June 8, 2012
Last Verified: June 2012

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


To Top