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.
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.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble-alpes
Grenoble
Jean-Luc FAUCHERON, MD-PhD
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.
- Conditions
- Hemorrhoidal Disease
- 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.
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.
- First posted29 Jan 2021
- Study start6 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoidal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Mastronicola, Principal investigator, CHU Grenoble AlpesJean Luc FAUCHERON, MD-PhD, Study director, CHU Grenoble Alpes
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After Hemorrhoidal Artery Ligation (HAL)
- ClinicalTrials.gov ID
- NCT04731064
- Acronym / sponsor ID
- HALTY / 38RC20.283
- Conditions
- Hemorrhoidal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Patient operated for hemorrhoidal disease for 10 or more
- Age 18 and over
- Informed patients
Key exclusion criteria (2 listed)
- Patient opposition
- Minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)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. | Procedure or surgery | – |
Primary outcome
The rate of recurrence leading to a re-intervention within 10 years of the intervention.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Related trials for Hemorrhoidal Disease
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Not yet recruitingPhase 2
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
Hemorrhoidal Disease
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgia Mastronicola principal investigator
CHU Grenoble Alpes
Jean Luc FAUCHERON, MD-PhD study director
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
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.