Clinical trial NCT03729414: Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids Prolapse
Keywords: Hemorrhoid
Doppler
Mucopexy
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2018-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: percentage of recurrences of hemorrhoidal prolapse
timeFrame: 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept of Emergency and Organ transplantation - University of Bari
Study officials:
affiliation: University of Bari
name: Donato F Altomare
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ratto C, Campenni 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. doi: 10.1007/s10151-017-1726-5. Epub 2017 Nov 24.
citation: 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. doi: 10.1007/s00384-003-0517-9. Epub 2003 Jul 5.