Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After HAL Doppler or HAL-RAR Intervention (HALTY)

Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After Hemorrhoidal Artery Ligation (HAL)

The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, via a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles) components. The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It has been popularized in France by some authors.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoidal Disease
• Intervention / Treatment: Procedure: HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)

Detailed Description

The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, by a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

Physiopathological basis of HAL Doppler The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Arttery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular components (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles). The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It was popularized in France by some authors.

Description of the operation The patient is operated on in the perineal first position, under general anesthesia or under locoregional or even local anesthesia. Most of the time, the procedure is performed on an outpatient basis, after rectal preparation with a simple enema.4,5 The equipment (there are several types) for HAL comprises a transparent disposable rectoscope provided near its end with a centimeter window through which the x-point ligatures of slowly absorbable 2/0 thread will be made. It contains a light source facilitating the exposure of the internal surface of the rectum and a Doppler transducer secured to the base of the rectoscope containing the Doppler system itself. The assembly is connected to a generator which will transmit the Doppler noises to the surgeon. A printer on the generator allows ligatures to be mapped and the depth of linked arteries to be noted.6 The rest of the equipment includes a needle holder, knot pusher, scissors and dissecting forceps to dab the surgical site if necessary.2 The material for HAL with mucopexy is identical, except for the disposable rectoscope which is much more indented at its end and on one side (and at the time of arterial ligation, covered by a metal or opalescent jacket leaving a window), so as to be able to carry out a vertical overlock in the lower rectum, above the package that the operator intends to treat. It is thus possible to make one or more mucopexies depending on the operative findings.

The procedure takes about 20 to 30 minutes. Two circumferential explorations are performed at the level of the lower rectum, approximately 25 and 40 mm above the pectinate line. Patients on anticoagulant or antiplatelet therapy can be operated using this technique, since there is no wound. The patient leaves the same day with paracetamol on demand, without special care at home.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Giorgia Mastronicola, MD; Phone Number: 0033476767079; Email: GMastronicola@chu-grenoble.fr
• Study Contact Backup: Name: Fatah TIDADINI; Phone Number: 0033476767079; Email: FTidadini@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • CHU Grenoble-Alpes
    • Contact: Jean-Luc FAUCHERON, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients operated for a disease in the digestive surgery and emergency departments will be included, provided they are not opposed.

Description

Inclusion Criteria:

• Patient operated for hemorrhoidal disease for 10 or more
• Age 18 and over
• Informed patients

Exclusion Criteria:

• Patient opposition
• Minor patient

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of recurrence leading to a re-intervention within 10 years of the intervention.	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Giorgia Mastronicola, CHU Grenoble Alpes; Study Director: Jean Luc FAUCHERON, MD-PhD, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 38RC20.283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No