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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01240772
First received: November 12, 2010
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Device: doppler-guided arterial ligation with mucopexy
Device: stapled haemorrhoidopexy according to Longo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Morbidity at 60 days postoperatively of the 2 techniques [ Time Frame: 60-90 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Cost-effectiveness of the 2 procedures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessment will be done according to Grade II vs Grade III patients as well as patients without and with antithrombotic treatments


Enrollment: 407
Study Start Date: December 2010
Study Completion Date: February 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240772

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

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01240772     History of Changes
Other Study ID Numbers: STIC/10/01, IDRCB 2010-A00642-37
Study First Received: November 12, 2010
Last Updated: August 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome

ClinicalTrials.gov processed this record on September 22, 2014