NCT03729414

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

Multicenter Randomized Controlled Trial of Doppler Guided Hemorrhoid Artery Ligation (DGHAL) and Mucopexy Versus Mucopexy Alone in the Treatment of Grade III Hemorrhoids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Societa Italiana di Chirurgia ColoRettale · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemorrhoids Prolapse

Interventions

Type	Name	Description
PROCEDURE	mucopexy with Doppler artery ligation	Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
PROCEDURE	mucopexy without Doppler artery ligation	Hemorrhoids will be treated by mucopexy alone performed in all quadrants

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-06-30
• Completion: 2022-11-30
• First posted: 2018-11-02
• Last updated: 2020-10-20

Locations

1 site across 1 country: Italy