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Hemorrhoidal DiseaseHALTYNCT04731064

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

An observational study of Hemorrhoidal Disease, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoidal Disease
What is being tested?
HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteFrance
Study dates
6 Jan 2023to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patient opposition
  • Minor patient

Trial locations and contacts

1 site in 1 country.

Giorgia Mastronicola, MD contact

0033476767079

GMastronicola@chu-grenoble.fr

France1 site, 1 recruiting
  • CHU Grenoble-alpes

    Grenoble

    Jean-Luc FAUCHERON, MD-PhD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)Procedure or surgery

    The patient is operated on in the first perineal position, under general anesthesia or under locoregional or even local anesthesia, after rectal preparation by simple enema. The HAL equipment included a disposable transparent rectoscope fitted near its end with a centimeter window through which wire stitch ligatures will be made. A light source facilitating the exposure of the internal face of the rectum and a Doppler transducer secured to the base of the rectoscope containing the Doppler system. Everything is connected to a generator which transmits Doppler noises to the surgeon. A printer on the generator makes it possible to map ligatures and note the depth of linked arteries. Equipment includes needle holder, knot pusher, scissors and dissecting forceps. The material for HAL is identical, except for the disposable rectoscope which is more indented at its end and on one side.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of recurrence leading to a re-intervention within 10 years of the intervention.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start6 Jan 2023
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04731064
Sponsor's protocol ID
38RC20.283
Acronym
HALTY
Status last verified
May 2024
First submitted
28 Jan 2021
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhoidal Disease, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giorgia Mastronicola, MD (0033476767079, GMastronicola@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of recurrence leading to a re-intervention within 10 years of the intervention. (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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