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

Hemorrhoids Prolapse Clinical Trial

— HAMLeT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729414
• Other study ID #: siccr
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2020
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Angela Accettura, md
• Phone: +39.0805592107
• Email: Angela.accettura[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids
• Hemorrhoids Prolapse
• Prolapse

Intervention

Procedure:
• mucopexy with Doppler artery ligation
Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
• mucopexy without Doppler artery ligation
Hemorrhoids will be treated by mucopexy alone performed in all quadrants

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation - University of Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bursics A, Morvay K, Kupcsulik P, Flautner L. Comparison of early and 1-year follow-up results of conventional hemorrhoidectomy and hemorrhoid artery ligation: a randomized study. Int J Colorectal Dis. 2004 Mar;19(2):176-80. Epub 2003 Jul 5. — View Citation

Ratto C, Campennì P, Papeo F, Donisi L, Litta F, Parello A. Transanal hemorrhoidal dearterialization (THD) for hemorrhoidal disease: a single-center study on 1000 consecutive cases and a review of the literature. Tech Coloproctol. 2017 Dec;21(12):953-962. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of recurrences of hemorrhoidal prolapse	Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees	1 year follow up