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

NCT03729414 | Unknown DMC

• 1 other identifier: siccr
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids Prolapse

Keywords

Hemorrhoid; Doppler; Mucopexy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

mucopexy with Doppler artery ligation

ACTIVE COMPARATOR

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

Procedure: mucopexy with Doppler artery ligation

mucopexy without Doppler artery ligation

EXPERIMENTAL

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

Procedure: mucopexy without Doppler artery ligation

Interventions

mucopexy with Doppler artery ligation PROCEDURE

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

Also known as: DGHAL

mucopexy with Doppler artery ligation

mucopexy without Doppler artery ligation PROCEDURE

Hemorrhoids will be treated by mucopexy alone performed in all quadrants

Also known as: NON-DGHAL

mucopexy without Doppler artery ligation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic grade III hemorrhoids according to Goligher
• No other source of anal bleeding than hemorrhoids
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead

Study Sites (1)

Dept of Emergency and Organ transplantation - University of Bari

Bari, 70124, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 29170839 RESULT

• 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.

  PMID: 12845454 RESULT

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Donato F Altomare

  University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Accettura, md

CONTACT

+39.0805592107; Angela.accettura@uniba.it

Donato F Altomare, MD

CONTACT

+39.0805592107; donatofrancesco.altomare@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: long term outcome will be evaluated by a third observer unaware of the type of surgery performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: November 2, 2018
• Study Start: September 30, 2020
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2022
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)