Status:
COMPLETED
Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
Lead Sponsor:
Nantes University Hospital
Conditions:
Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The ...
Eligibility Criteria
Inclusion
- Patient (male or female) 18 - 75 y.o
- Suffering from symptomatic grade II or III haemorrhoidal disease (bleeding and/or prolapse)
- requiring surgery
Exclusion
- Acute complication of haemorrhoidal disease
- History of anal surgery for haemorrhoids
- Congenital or acquirred anal stenosis
- Anal fissure or perianal abcess
- Inflammatory bowel disease
- Colon or rectal cancerv History of rectal or sigmoid resection
- Rectal prolapse
- Portal vein hypertension
- Haemophylia
- Pregnancy
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT01240772
Start Date
December 1 2010
End Date
February 1 2014
Last Update
August 25 2014
Active Locations (22)
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1
Angers University Hospital
Angers, France, 49033
2
Grenoble University Hospital
Grenoble, France
3
La Roche/Yon Hospital
La Roche/Yon, France
4
Lille University Hospital "Claude Huriez"
Lille, France