HemorrhoidsHANDNCT04119401
Hemorrhoid Artery LigatioN Without Doppler Trial
A study testing doppler-guided hemorrhoidal artery ligation and Finger-guided hemorrhoidal artery ligation in people with Hemorrhoids, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- doppler-guided hemorrhoidal artery ligation and Finger-guided hemorrhoidal artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 8 Jan 2019to 11 Jan 2021
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic grade II and III hemorrhoids according to Golligher.
- No other source of anal bleeding than hemorrhoids due to total colonoscopy
- Written voluntary informed consent
Who cannot join
- Any previous hemorrhoid surgery (including mini invasive procedures)
- Anal fistula
- Chronic anal fissure with severe spasm of anal sphincters
- Any stage colorectal cancer
- Oral anticoagulants for congenital disorders of the coagulation system
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally invasive surgery
Moscow, 119435
Inna Tulina, MD, +79264086672, tulina@kkmx.ru
Petr Tsarkov, PhD
About this study
Official title: Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial
Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.
The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.
Read more
In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery.
Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.
Read the detailed description
Hemorrhoidal disease (HD), in its different manifestations, is not only the most frequented grounds of referring for medical attention, but also one of the reasons for the modest deterioration in the quality of life that can possibly result in temporary or permanent reduction of work capacities. Today, the doppler-guided dearterialization of hemorrhoidal arteries and the following suture-fixation mucopexy in the anal canal (synonyms: mucopexy, hemorrhoids lifting, HAL-RAR) is one of the most popular and actively studied methods of the stage II - III hemorrhoidal disease surgical treatment. A number of publications raise an issue whether it is really necessary to use a doppler while the localization of the hemorrhoidal arteries is typical in the vast majority of the observations and can be easily determined on palpation.
The aim of the study is to compare the direct and long-term results of the II - III grade HD surgical treatment with the use of two techniques of the suture ligation of the hemorrhoidal arteries with mucopexy. One of these methods is classic and widely known HAL-RAR, the other one has a principal differ in no-using the doppler to find the arteries, the surgeon defines them on palpation.
The hypothesis of the study is that the digital detection of hemorrhoidal arteries pulsation followed by suture ligation and mucopexy may be no less effective in the treatment of grade II - III hemorrhoids than the use of a doppler guide.
- Conditions
- Hemorrhoids
- Being tested
- doppler-guided hemorrhoidal artery ligation, Finger-guided hemorrhoidal artery ligation
- Keywords
- hemorrhoids, hemorrhoidal piles, prolapse, doppler guided ligation, finger-guided artery ligation
- Medical subject headings
- Hemorrhoids, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler-guided hemorrhoidal artery ligationProcedure or surgery
Ligation: a lubricating gel is applied to the tip of the Transanal Hemorrhoidal Dearterialization device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. The terminal branches of the superior rectal artery are detected by the doppler signal 2-3 cm above the dentate line. The tip of the instrument is gently tilted and the arteries are ligated with a Z-shaped stitch using 2:0 braided polyglycolic acid suture inserted using a special needle-holder through an aperture in the operating proctoscope.
Mucopexy: after the haemorrhoid artery ligation, the suture is continued with three to five 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 detected artery ligations.
Finger-guided hemorrhoidal artery ligationProcedure or surgery
Ligation: the exact placement of all terminal branches of the superior rectal artery are found by intraoperative palpation at anal clock 2-3cm above the anorectal junction. Then arteries are ligated with Z-shaped suture using 2:0 braided polyglycolic suture.
Mucopexy is then performed in the same technique as in comparative group
| Study group | Role | What they receive |
|---|---|---|
| doppler-guided | Active comparator | ligation of hemorrhoidal arteries with doppler guidance Receives: Procedure: doppler-guided hemorrhoidal artery ligation |
| finger-guided group | Experimental | ligation of hemorrhoidal arteries without doppler guidance but with finger detection Receives: Procedure: Finger-guided hemorrhoidal artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
The rate of recurrence of any of initial symptoms or appearance of any new symptom of hemorrhoidal disease: anal bleeding during defecation, prolapse of hemorrhoidal piles or both.
Measured: 2 weeks - 1 year
Secondary outcomes (2)
Pain score
pain score after surgery will be measured by patient-reported pain level using visual scale ranging from 1 to 10 where 1 is "no pain" and 10 - is the the worst pain imaginable.
Measured: 2 weeks
Patients satisfaction level
Patients will be asked to rate their own satisfaction of the procedure on a scale from 1 to 10 (with 10 being the best) and were asked whether the procedure helped their symptoms.
Measured: 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start8 Jan 2019
- Primary completion10 Oct 2020 (estimated)
- Study completion11 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119401
- Sponsor's protocol ID
- 683473
- Acronym
- HAND
- Status last verified
- Mar 2020
- First submitted
- 6 Oct 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aigner F, Bodner G, Conrad F, Mbaka G, Kreczy A, Fritsch H. The superior rectal artery and its branching pattern with regard to its clinical influence on ligation techniques for internal hemorrhoids. Am J Surg. 2004 Jan;187(1):102-8. doi: 10.1016/j.amjsurg.2002.11.003.
PubMed 14706597Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.
PubMed 27236344Hoyuela C, Carvajal F, Juvany M, Troyano D, Trias M, Martrat A, Ardid J, Obiols J. HAL-RAR (Doppler guided haemorrhoid artery ligation with recto-anal repair) is a safe and effective procedure for haemorrhoids. Results of a prospective study after two-years follow-up. Int J Surg. 2016 Apr;28:39-44. doi: 10.1016/j.ijsu.2016.02.030. Epub 2016 Feb 10.
PubMed 26876958Morinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995 Apr;90(4):610-3.
PubMed 7717320Ratto 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.
PubMed 29170839
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04119401
- Acronym / sponsor ID
- HAND / 683473
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids, hemorrhoidal piles, prolapse, doppler guided ligation, finger-guided artery ligation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 10 Oct 2020 (estimated)
- Study completion
- 11 Jan 2021 (estimated)
- First posted
- 8 Oct 2019 (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.
Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.
The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.
In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery.
Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.
Detailed description
Hemorrhoidal disease (HD), in its different manifestations, is not only the most frequented grounds of referring for medical attention, but also one of the reasons for the modest deterioration in the quality of life that can possibly result in temporary or permanent reduction of work capacities. Today, the doppler-guided dearterialization of hemorrhoidal arteries and the following suture-fixation mucopexy in the anal canal (synonyms: mucopexy, hemorrhoids lifting, HAL-RAR) is one of the most popular and actively studied methods of the stage II - III hemorrhoidal disease surgical treatment. A number of publications raise an issue whether it is really necessary to use a doppler while the localization of the hemorrhoidal arteries is typical in the vast majority of the observations and can be easily determined on palpation.
The aim of the study is to compare the direct and long-term results of the II - III grade HD surgical treatment with the use of two techniques of the suture ligation of the hemorrhoidal arteries with mucopexy. One of these methods is classic and widely known HAL-RAR, the other one has a principal differ in no-using the doppler to find the arteries, the surgeon defines them on palpation.
The hypothesis of the study is that the digital detection of hemorrhoidal arteries pulsation followed by suture ligation and mucopexy may be no less effective in the treatment of grade II - III hemorrhoids than the use of a doppler guide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doppler-guided | Active comparator | Procedure: doppler-guided hemorrhoidal artery ligationligation of hemorrhoidal arteries with doppler guidance |
| finger-guided group | Experimental | Procedure: Finger-guided hemorrhoidal artery ligationligation of hemorrhoidal arteries without doppler guidance but with finger detection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic grade II and III hemorrhoids according to Golligher.
- No other source of anal bleeding than hemorrhoids due to total colonoscopy
- Written voluntary informed consent
Key exclusion criteria (6 listed)
- Any previous hemorrhoid surgery (including mini invasive procedures)
- Anal fistula
- Chronic anal fissure with severe spasm of anal sphincters
- Any stage colorectal cancer
- Oral anticoagulants for congenital disorders of the coagulation system
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 |
|---|---|---|
| doppler-guided hemorrhoidal artery ligationLigation: a lubricating gel is applied to the tip of the Transanal Hemorrhoidal Dearterialization device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. The terminal branches of the superior rectal artery are detected by the doppler signal 2-3 cm above the dentate line. The tip of the instrument is gently tilted and the arteries are ligated with a Z-shaped stitch using 2:0 braided polyglycolic acid suture inserted using a special needle-holder through an aperture in the operating proctoscope. Mucopexy: after the haemorrhoid artery ligation, the suture is continued with three to five 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 detected artery ligations. | Procedure or surgery | doppler-guided |
| Finger-guided hemorrhoidal artery ligationLigation: the exact placement of all terminal branches of the superior rectal artery are found by intraoperative palpation at anal clock 2-3cm above the anorectal junction. Then arteries are ligated with Z-shaped suture using 2:0 braided polyglycolic suture. Mucopexy is then performed in the same technique as in comparative group | Procedure or surgery | finger-guided group |
Primary outcome
recurrence
Time frame: 2 weeks - 1 year
The rate of recurrence of any of initial symptoms or appearance of any new symptom of hemorrhoidal disease: anal bleeding during defecation, prolapse of hemorrhoidal piles or both.
2 secondary outcomes
Pain score
Time frame: 2 weeks
Patients satisfaction level
Time frame: 6 month and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Results publication: PubMed 14706597Aigner F, Bodner G, Conrad F, Mbaka G, Kreczy A, Fritsch H. The superior rectal artery and its branching pattern with regard to its clinical influence on ligation techniques for internal hemorrhoids. Am J Surg. 2004 Jan;187(1):102-8. doi: 10.1016/j.amjsurg.2002.11.003.
- Results publication: PubMed 27236344Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.
- Results publication: PubMed 26876958Hoyuela C, Carvajal F, Juvany M, Troyano D, Trias M, Martrat A, Ardid J, Obiols J. HAL-RAR (Doppler guided haemorrhoid artery ligation with recto-anal repair) is a safe and effective procedure for haemorrhoids. Results of a prospective study after two-years follow-up. Int J Surg. 2016 Apr;28:39-44. doi: 10.1016/j.ijsu.2016.02.030. Epub 2016 Feb 10.
- Results publication: PubMed 7717320Morinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995 Apr;90(4):610-3.
- Results publication: PubMed 29170839Ratto 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.
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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.
Petr Tsarkov, Prof principal investigator
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doppler-guided hemorrhoidal artery ligation and Finger-guided hemorrhoidal artery ligation in people with Hemorrhoids, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
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 6 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 25 Mar 2020. 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 Russia. 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 Daniil Markaryan, MD (+79035329245, markaryan@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 2 weeks - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119401, which also lists 5 linked publications.
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 25 Mar 2020.