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NCT Number: NCT01240772

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

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.

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Key information

Conditions

Symptomatic Haemorrhoidal Disease Requiring Surgical Management Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

doppler-guided arterial ligation with mucopexy

Device

doppler-guided arterial ligation with mucopexy

Other names: THD, AMI

stapled haemorrhoidopexy according to Longo

Device

stapled haemorrhoidopexy according to Longo

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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)

Acronym: LIGALONGO

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 15, 2010
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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