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

Not Applicable

• Conditions: Hemorrhoids Prolapse
• Interventions: Procedure: mucopexy with Doppler artery ligation; Procedure: mucopexy without Doppler artery ligation

• Registration Number: NCT03729414
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Study Start: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-06-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mucopexy with Doppler artery ligation	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
mucopexy without Doppler artery ligation	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

Primary Outcome Measures

Name	Time	Method
percentage of recurrences of hemorrhoidal prolapse	1 year follow up	Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees

Trial Locations

Locations (1)

Dept of Emergency and Organ transplantation - University of Bari; 🇮🇹 Bari, Italy