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

NCT ID: NCT01240772

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-02-28

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.

Detailed Description

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Conditions

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Symptomatic Haemorrhoidal Disease Requiring Surgical Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DGALM

doppler-guided arterial ligation with mucopexy

Group Type EXPERIMENTAL

doppler-guided arterial ligation with mucopexy

Intervention Type DEVICE

doppler-guided arterial ligation with mucopexy

SH

stapled haemorrhoidopexy according to Longo

Group Type ACTIVE_COMPARATOR

stapled haemorrhoidopexy according to Longo

Intervention Type DEVICE

stapled haemorrhoidopexy according to Longo

Interventions

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doppler-guided arterial ligation with mucopexy

doppler-guided arterial ligation with mucopexy

Intervention Type DEVICE

stapled haemorrhoidopexy according to Longo

stapled haemorrhoidopexy according to Longo

Intervention Type DEVICE

Other Intervention Names

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THD AMI

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Angers University Hospital

Angers, , France

Site Status

Grenoble University Hospital

Grenoble, , France

Site Status

La Roche/Yon Hospital

La Roche/Yon, , France

Site Status

Lille University Hospital "Claude Huriez"

Lille, , France

Site Status

Marseille University Hospital "Hôpital Nord"

Marseille, , France

Site Status

Marseille University Hospital "La Timone"

Marseille, , France

Site Status

Nantes University Hospital

Nantes, , France

Site Status

Niort Hospital

Niort, , France

Site Status

Nîmes University Hospital

Nîmes, , France

Site Status

Polyclinic H. MALARTIC

Ollioules, , France

Site Status

"Institut Mutualiste Montsouris"

Paris, , France

Site Status

Hopital St Joseph

Paris, , France

Site Status

Poissy / Saint-Germain en Laye Hospital

Poissy, , France

Site Status

Rennes University Hospital

Rennes, , France

Site Status

Saint-Etienne University Hospital

Saint-Etienne, , France

Site Status

"Pôle Hospitalier Mutualiste"

Saint-Nazaire, , France

Site Status

Strasbourg University Hospital

Strasbourg, , France

Site Status

Foch Hospital

Suresnes, , France

Site Status

Talence Bagatelle Hospital

Talence, , France

Site Status

Toulouse University Hospital

Toulouse, , France

Site Status

Tours University Hospital

Tours, , France

Site Status

Vichy Hospital

Vichy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32460882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29808305 (View on PubMed)

Other Identifiers

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IDRCB 2010-A00642-37

Identifier Type: OTHER

Identifier Source: secondary_id

STIC/10/01

Identifier Type: -

Identifier Source: org_study_id

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