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

Phase 3

Completed

• Conditions: Symptomatic Haemorrhoidal Disease Requiring Surgical Management
• Interventions: Device: doppler-guided arterial ligation with mucopexy; Device: stapled haemorrhoidopexy according to Longo

• Registration Number: NCT01240772
• Lead Sponsor: Nantes University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Study Start: 2010-12
• Primary Completion: 2013-04
• Study Completion: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DGALM	doppler-guided arterial ligation with mucopexy	doppler-guided arterial ligation with mucopexy
SH	stapled haemorrhoidopexy according to Longo	stapled haemorrhoidopexy according to Longo

Primary Outcome Measures

Name	Time	Method
Morbidity at 60 days postoperatively of the 2 techniques	60-90 days	Morbidity at 60 days postoperatively of the 2 techniques, the morbidity being defined as " the sum of adverse events that occurred during or after the procedure for a period of 2 months".Primary outcome measure is "the percentage of patients with complication, whatever the number of complications per patient and the grade of complication according to the Clavien-Dindo classification".

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of the 2 procedures	12 months	global cost of the treatment, length of stay, sick leave, cost of complications and sequelae management
Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms	1 year	Efficiency regarding the cure of haemorrhoidal symptoms that led to surgery; * Pain; * Persisting or recurring symptoms of haemorrhoidal disease; * Prolapse; * Bleeding; * Haemorrhoidal thrombose; * Occurrence of new anal symptoms / surgical sequelae; * Incontinence; * Soiling; * Pruritus; * Anal stenosis; * Constipation; * Fissure; * Other rare complication
Rate of anatomical or functional sequelae	1 year	Assessment will be done according to Grade II vs Grade III patients as well as patients without and with antithrombotic treatments

Trial Locations

Locations (22)

Hopital St Joseph; 🇫🇷 Paris, France

"Institut Mutualiste Montsouris"; 🇫🇷 Paris, France

Angers University Hospital; 🇫🇷 Angers, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

La Roche/Yon Hospital; 🇫🇷 La Roche/Yon, France

Marseille University Hospital "La Timone"; 🇫🇷 Marseille, France

Lille University Hospital "Claude Huriez"; 🇫🇷 Lille, France

Marseille University Hospital "Hôpital Nord"; 🇫🇷 Marseille, France

Nantes University Hospital; 🇫🇷 Nantes, France

Nîmes University Hospital; 🇫🇷 Nîmes, France

Polyclinic H. MALARTIC; 🇫🇷 Ollioules, France

Poissy / Saint-Germain en Laye Hospital; 🇫🇷 Poissy, France

Niort Hospital; 🇫🇷 Niort, France

Rennes University Hospital; 🇫🇷 Rennes, France

Saint-Etienne University Hospital; 🇫🇷 Saint-Etienne, France

"Pôle Hospitalier Mutualiste"; 🇫🇷 Saint-Nazaire, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Foch Hospital; 🇫🇷 Suresnes, France

Talence Bagatelle Hospital; 🇫🇷 Talence, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Tours University Hospital; 🇫🇷 Tours, France

Vichy Hospital; 🇫🇷 Vichy, France