CompletedPhase 3

Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy

France407 participantsStarted 2010-12

Plain-language 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 hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient (male or female) 18 - 75 y.o * Suffering from symptomatic grade II or III haemorrhoidal disease (bleeding and/or prolapse) * requiring surgery Exclusion Criteria: * 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

What they're measuring

Morbidity at 60 days postoperatively of the 2 techniques

Timeframe: 60-90 days

Trial details

NCT IDNCT01240772

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Symptomatic Haemorrhoidal Disease Requiring Surgical Management trials