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

Study Overview
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Brief Summary
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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.

Official Title
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Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)

Conditions
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Symptomatic Haemorrhoidal Disease Requiring Surgical Management

Intervention / Treatment
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* Device: doppler-guided arterial ligation with mucopexy
* Device: stapled haemorrhoidopexy according to Longo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DGALM<br>doppler-guided arterial ligation with mucopexy | Device: doppler-guided arterial ligation with mucopexy<br>* doppler-guided arterial ligation with mucopexy<br>* Other names: AMI;|
| Active Comparator: SH<br>stapled haemorrhoidopexy according to Longo | Device: stapled haemorrhoidopexy according to Longo<br>* stapled haemorrhoidopexy according to Longo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60-90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of the 2 procedures | global cost of the treatment, length of stay, sick leave, cost of complications and sequelae management | 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 | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome