Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy
Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 17, 2010
CompletedFirst Posted
Study publicly available on registry
December 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJanuary 22, 2015
January 1, 2015
9 months
December 17, 2010
January 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
1 week
Secondary Outcomes (4)
postoperative morbidity
30 days
resumption of working activity
30 days
patient's satisfaction
30 days
Relapse
24 months
Study Arms (2)
Hemorrhoidectomy
ACTIVE COMPARATORExcision of hemorrhoid cushions
Hemorrhoidal dearterialization
EXPERIMENTALLigation of therminbal branches oh hemorrhoid arteries
Interventions
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
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
Eligibility Criteria
You may qualify if:
- Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids
You may not qualify if:
- Previous anal surgery or pelvic radiotherapy
- Fecal incontinence or obstructed defecation
- IBD, IBS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Scientific Institute
Milan, 20132, Italy
Related Publications (1)
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.
PMID: 24509458DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paola De Nardi, MD
San Raffaele Scientific Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 17, 2010
First Posted
December 20, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
January 22, 2015
Record last verified: 2015-01