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

June 4, 2012
June 7, 2012
October 2008
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01615575 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Haemorrhoids
  • 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
  • Procedure: Stapler haemorrhoidopexy
    Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).
  • 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.
    Intervention: Procedure: Transanal haemorrhoidal dearterialisation
  • Active Comparator: Stapler haemorrhoidopexy
    Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)
    Intervention: Procedure: Stapler haemorrhoidopexy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Arab Emirates
 
NCT01615575
URomLS1
No
Erasmo Spaziani, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: Pierino Lucarelli, MD, FRCS
University of Roma La Sapienza
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP