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

NCT ID: NCT03729414

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-11-30

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

Conditions

Hemorrhoids Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

mucopexy with Doppler artery ligation

Intervention Type: PROCEDURE

Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants

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

Group Type: EXPERIMENTAL

mucopexy without Doppler artery ligation

Intervention Type: PROCEDURE

Hemorrhoids will be treated by mucopexy alone performed in all quadrants

Interventions

mucopexy with Doppler artery ligation

Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants

Intervention Type: PROCEDURE

mucopexy without Doppler artery ligation

Hemorrhoids will be treated by mucopexy alone performed in all quadrants

Intervention Type: PROCEDURE

Other Intervention Names

DGHAL; NON-DGHAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donato F Altomare

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Dept of Emergency and Organ transplantation - University of Bari

Bari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Angela Accettura, md

Role: CONTACT

Angela.accettura@uniba.it

+39.0805592107 ext. +39

Donato F Altomare, MD

Role: CONTACT

donatofrancesco.altomare@uniba.it

+39.0805592107 ext. +39

Facility Contacts

Donato F Altomare, MD

Role: primary

donatofrancesco.altomare@uniba.it

References

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.

Reference Type: RESULT

PMID: 29170839 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12845454 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

siccr

Identifier Type: -

Identifier Source: org_study_id