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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
407
doppler-guided arterial ligation with mucopexy
stapled haemorrhoidopexy according to Longo
Angers University Hospital
Angers, France
Grenoble University Hospital
Grenoble, France
La Roche/Yon Hospital
La Roche/Yon, France
Lille University Hospital "Claude Huriez"
Lille, France
Marseille University Hospital "Hôpital Nord"
Marseille, France
Marseille University Hospital "La Timone"
Marseille, France
Nantes University Hospital
Nantes, France
Niort Hospital
Niort, France
Nîmes University Hospital
Nîmes, France
Polyclinic H. MALARTIC
Ollioules, France
...and 12 more locations
Morbidity at 60 days postoperatively of the 2 techniques
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".
Time frame: 60-90 days
Cost-effectiveness of the 2 procedures
global cost of the treatment, length of stay, sick leave, cost of complications and sequelae management
Time frame: 12 months
Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms
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
Time frame: 1 year
Rate of anatomical or functional sequelae
Assessment will be done according to Grade II vs Grade III patients as well as patients without and with antithrombotic treatments
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.