Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04731064 |
| Other study ID # |
38RC20.283 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital, Grenoble |
| Contact |
Giorgia Mastronicola, MD |
| Phone |
0033476767079 |
| Email |
GMastronicola[@]chu-grenoble.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
