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

August 22, 2014 updated by: Nantes University Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Angers University Hospital
      • Grenoble, France
        • Grenoble University Hospital
      • La Roche/Yon, France
        • La Roche/Yon Hospital
      • Lille, France
        • Lille University Hospital "Claude Huriez"
      • Marseille, France
        • Marseille University Hospital "Hôpital Nord"
      • Marseille, France
        • Marseille University Hospital "La Timone"
      • Nantes, France, 44000
        • Nantes University Hospital
      • Niort, France
        • Niort Hospital
      • Nîmes, France
        • Nîmes University Hospital
      • Ollioules, France
        • Polyclinic H. MALARTIC
      • Paris, France
        • "Institut Mutualiste Montsouris"
      • Paris, France
        • Hôpital St Joseph
      • Poissy, France
        • Poissy / Saint-Germain en Laye Hospital
      • Rennes, France
        • Rennes University Hospital
      • Saint-Etienne, France
        • Saint-Etienne University Hospital
      • Saint-Nazaire, France
        • "Pôle Hospitalier Mutualiste"
      • Strasbourg, France
        • Strasbourg university hospital
      • Suresnes, France
        • Foch Hospital
      • Talence, France
        • Talence Bagatelle Hospital
      • Toulouse, France
        • Toulouse University Hospital
      • Tours, France
        • Tours university Hospital
      • Vichy, France
        • Vichy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DGALM
doppler-guided arterial ligation with mucopexy
Device: doppler-guided arterial ligation with mucopexy
doppler-guided arterial ligation with mucopexy
Other Names:
  • THD
  • AMI
Active Comparator: SH
stapled haemorrhoidopexy according to Longo
Device: stapled haemorrhoidopexy according to Longo
stapled haemorrhoidopexy according to Longo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity at 60 days postoperatively of the 2 techniques
Time Frame: 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".
60-90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of the 2 procedures
Time Frame: 12 months
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
Time Frame: 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
1 year
Rate of anatomical or functional sequelae
Time Frame: 1 year
Assessment will be done according to Grade II vs Grade III patients as well as patients without and with antithrombotic treatments
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STIC/10/01
  • IDRCB 2010-A00642-37 (Other Identifier: Afssaps)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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