Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Conditions
Keywords
Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome
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.
Interventions
DEVICEdoppler-guided arterial ligation with mucopexy
doppler-guided arterial ligation with mucopexy
DEVICEstapled haemorrhoidopexy according to Longo
stapled haemorrhoidopexy according to Longo
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed