Clinical trial NCT01240772: Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Keywords: Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morbidity at 60 days postoperatively of the 2 techniques
timeFrame: 60-90 days
Secondary outcomes:
measure: Cost-effectiveness of the 2 procedures
timeFrame: 12 months
measure: Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms
timeFrame: 1 year
measure: Rate of anatomical or functional sequelae
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: La Roche/Yon
country: France
facility: La Roche/Yon Hospital
city: Lille
country: France
facility: Lille University Hospital "Claude Huriez"
city: Marseille
country: France
facility: Marseille University Hospital "Hôpital Nord"
city: Marseille
country: France
facility: Marseille University Hospital "La Timone"
city: Nantes
country: France
facility: Nantes University Hospital
city: Niort
country: France
facility: Niort Hospital
city: Nîmes
country: France
facility: Nîmes University Hospital
city: Ollioules
country: France
facility: Polyclinic H. MALARTIC
city: Paris
country: France
facility: "Institut Mutualiste Montsouris"
city: Paris
country: France
facility: Hopital St Joseph
city: Poissy
country: France
facility: Poissy / Saint-Germain en Laye Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Etienne
country: France
facility: Saint-Etienne University Hospital
city: Saint-Nazaire
country: France
facility: "Pôle Hospitalier Mutualiste"
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Suresnes
country: France
facility: Foch Hospital
city: Talence
country: France
facility: Talence Bagatelle Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hospital
city: Vichy
country: France
facility: Vichy Hospital
Study officials:
References:
citation: Woaye-Hune P, Hardouin JB, Lehur PA, Meurette G, Vanier A. Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes. Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 10.1186/s12955-020-01398-w.
citation: Venara A, Podevin J, Godeberge P, Redon Y, Barussaud ML, Sielezneff I, Queralto M, Bourbao C, Chiffoleau A, Lehur PA; LigaLongo Study Group. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis. 2018 Oct;33(10):1479-1483. doi: 10.1007/s00384-018-3093-8. Epub 2018 May 28.