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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

November 12, 2010
August 22, 2014
December 2010
April 2013   (final data collection date for primary outcome measure)
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".
Same as current
Complete list of historical versions of study NCT01240772 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Symptomatic Haemorrhoidal Disease Requiring Surgical Management
  • Device: doppler-guided arterial ligation with mucopexy
    doppler-guided arterial ligation with mucopexy
    Other Names:
    • THD
    • AMI
  • Device: stapled haemorrhoidopexy according to Longo
    stapled haemorrhoidopexy according to Longo
  • Experimental: DGALM
    doppler-guided arterial ligation with mucopexy
    Intervention: Device: doppler-guided arterial ligation with mucopexy
  • Active Comparator: SH
    stapled haemorrhoidopexy according to Longo
    Intervention: Device: stapled haemorrhoidopexy according to Longo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
407
February 2014
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01240772
STIC/10/01, IDRCB 2010-A00642-37
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP