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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Symptomatic Haemorrhoidal Disease Requiring Surgical Management

Treatments: Device: stapled haemorrhoidopexy according to Longo; Device: doppler-guided arterial ligation with mucopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01240772

STIC/10/01

IDRCB 2010-A00642-37 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 2 patient groups

DGALM

Experimental group

Description:

doppler-guided arterial ligation with mucopexy

Treatment:

Device: doppler-guided arterial ligation with mucopexy

SH

Active Comparator group

Description:

stapled haemorrhoidopexy according to Longo

Treatment:

Device: stapled haemorrhoidopexy according to Longo