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Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

Primary Purpose

Third Degree Hemorrhoids

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Hemorrhoidectomy
Hemorrhoidal dearterialization
Sponsored by
Scientific Institute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Third Degree Hemorrhoids focused on measuring Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids

Exclusion Criteria:

  • Previous anal surgery or pelvic radiotherapy
  • Fecal incontinence or obstructed defecation
  • IBD, IBS

Sites / Locations

  • San Raffaele Scientific Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hemorrhoidectomy

Hemorrhoidal dearterialization

Arm Description

Excision of hemorrhoid cushions

Ligation of therminbal branches oh hemorrhoid arteries

Outcomes

Primary Outcome Measures

postoperative pain

Secondary Outcome Measures

postoperative morbidity
resumption of working activity
patient's satisfaction
Relapse

Full Information

First Posted
December 17, 2010
Last Updated
January 21, 2015
Sponsor
Scientific Institute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01263431
Brief Title
Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy
Official Title
Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scientific Institute San Raffaele

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction
Detailed Description
Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Degree Hemorrhoids
Keywords
Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemorrhoidectomy
Arm Type
Active Comparator
Arm Description
Excision of hemorrhoid cushions
Arm Title
Hemorrhoidal dearterialization
Arm Type
Experimental
Arm Description
Ligation of therminbal branches oh hemorrhoid arteries
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidectomy
Intervention Description
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidal dearterialization
Intervention Description
A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
1 week
Secondary Outcome Measure Information:
Title
postoperative morbidity
Time Frame
30 days
Title
resumption of working activity
Time Frame
30 days
Title
patient's satisfaction
Time Frame
30 days
Title
Relapse
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids Exclusion Criteria: Previous anal surgery or pelvic radiotherapy Fecal incontinence or obstructed defecation IBD, IBS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola De Nardi, MD
Organizational Affiliation
San Raffaele Scientific Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Scientific Institute
City
Milano
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24509458
Citation
De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.
Results Reference
derived

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Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

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