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Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question (HAMLeT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729414
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Societa Italiana di Chirurgia ColoRettale

Brief Summary:

Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL).

This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures.

Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy.

In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure.

The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.


Condition or disease Intervention/treatment Phase
Hemorrhoids Prolapse Procedure: mucopexy with Doppler artery ligation Procedure: mucopexy without Doppler artery ligation Not Applicable

Detailed Description:

Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.

Primary aim of the Hamlet trial is to demonstrate that mucopexy without DGHAL for grade III haemorrhoids have equivalent recurrence rate at 1 year follow up of DGHAL with mucopexy procedure

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.
Masking: Single (Outcomes Assessor)
Masking Description: long term outcome will be evaluated by a third observer unaware of the type of surgery performed
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial of Doppler Guided Hemorrhoid Artery Ligation (DGHAL) and Mucopexy Versus Mucopexy Alone in the Treatment of Grade III Hemorrhoids
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Active Comparator: mucopexy with Doppler artery ligation
Doppler guided hemorrhoidal artery ligation and mucopexy: Group of patients with III degree hemorrhoids treated by THD or AMI device is introduced into the anal canal. The terminal branches of the rectal artery are detected by the Doppler 2-3 cm above the dentate line. The tip of the instrument is tilted and arteries ligated with a figure-of-eight suture inserted using a special needle-holder. After the haemorrhoid artery ligation, the suture is continued with 3/5 sutures applied 5 mm apart, making sure that the last is at least 5 mm above the dentate line. The suture is then tied to create a hemorrhoidopexy. The procedure is repeated after all artery ligations (6 ligations
Procedure: mucopexy with Doppler artery ligation
Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
Other Name: DGHAL

Experimental: mucopexy without Doppler artery ligation
Non Doppler guided hemorrhoidal artery ligation and mucopexy: A lubricating gel is applied to the tip of the THD or the AMI device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. the mucopexy will start at two o'clock and repeated at 4, 6 8, 10, 12, in clockwise direction
Procedure: mucopexy without Doppler artery ligation
Hemorrhoids will be treated by mucopexy alone performed in all quadrants
Other Name: NON-DGHAL




Primary Outcome Measures :
  1. percentage of recurrences of hemorrhoidal prolapse [ Time Frame: 1 year follow up ]
    Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic grade III hemorrhoids according to Goligher
  • No other source of anal bleeding than hemorrhoids
  • Written informed consent

Exclusion Criteria:

  • Any previous hemorrhoid surgery
  • Participants expressing clear preference for one of the interventions
  • Pregnancy
  • Inability to understand the informed consent
  • Oral anticoagulants of congenital defects of the coagulation
  • Patients with immunodepression (i.e. HIV)
  • Other proctological diseases (fissures, fistulas, condyloma, etc)
  • IBD involving the anus ore the rectum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729414


Contacts
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Contact: Angela Accettura, md +39.0805592107 ext +39 Angela.accettura@uniba.it
Contact: Donato F Altomare, MD +39.0805592107 ext +39 donatofrancesco.altomare@uniba.it

Locations
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Italy
Dept of Emergency and Organ transplantation - University of Bari
Bari, Italy, 70124
Contact: Donato F Altomare, MD       donatofrancesco.altomare@uniba.it   
Principal Investigator: Donato F Altomare, MD         
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
Investigators
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Principal Investigator: Donato F Altomare University of Bari, Italy
  Study Documents (Full-Text)

Documents provided by Societa Italiana di Chirurgia ColoRettale:
Study Protocol  [PDF] October 10, 2018


Publications of Results:
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Responsible Party: Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier: NCT03729414    
Other Study ID Numbers: siccr
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Societa Italiana di Chirurgia ColoRettale:
Hemorrhoid
Doppler
Mucopexy
Additional relevant MeSH terms:
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Hemorrhoids
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases