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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01240772
First received: November 12, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

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


Estimated Enrollment: 438
Study Start Date: December 2010
Estimated Study Completion Date: January 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240772

Locations
France
Nantes University Hospital
Nantes, France, 44000
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: February 22, 2013
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 May 23, 2013