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

Tracking Information
First Received Date ^ICMJE	November 12, 2010
Last Updated Date	February 22, 2013
Start Date ^ICMJE	December 2010
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2010)	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".
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01240772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 12, 2010)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	438
Estimated Completion Date	January 2014
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01240772
Other Study ID Numbers ^ICMJE	STIC/10/01, IDRCB 2010-A00642-37
Has Data Monitoring Committee	No
Responsible Party	Nantes University Hospital
Study Sponsor ^ICMJE	Nantes University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nantes University Hospital
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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