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Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

Primary Purpose

Haemorrhoids

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Transanal haemorrhoidal dearterialisation
Stapler haemorrhoidopexy
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemorrhoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Haemorrhoidal dearterialisation

Stapler haemorrhoidopexy

Arm Description

Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.

Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)

Outcomes

Primary Outcome Measures

Recurrence
A telephone interview with a structured questionnaire at a median follow-up of 42 months.

Secondary Outcome Measures

Postoperative pain
Pain score 24 hr after operation
Complications
Intra and postoperative complication within 30 days.

Full Information

First Posted
June 4, 2012
Last Updated
June 7, 2012
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01615575
Brief Title
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy
Official Title
Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemorrhoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haemorrhoidal dearterialisation
Arm Type
Active Comparator
Arm Description
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.
Arm Title
Stapler haemorrhoidopexy
Arm Type
Active Comparator
Arm Description
Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)
Intervention Type
Procedure
Intervention Name(s)
Transanal haemorrhoidal dearterialisation
Intervention Description
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy
Intervention Type
Procedure
Intervention Name(s)
Stapler haemorrhoidopexy
Intervention Description
Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).
Primary Outcome Measure Information:
Title
Recurrence
Description
A telephone interview with a structured questionnaire at a median follow-up of 42 months.
Time Frame
42 months
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Pain score 24 hr after operation
Time Frame
24 hr
Title
Complications
Description
Intra and postoperative complication within 30 days.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierino Lucarelli, MD, FRCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
The City Hospital
City
Dubai
ZIP/Postal Code
P O Box 505004
Country
United Arab Emirates

12. IPD Sharing Statement

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Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

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