HemorrhoidsNCT04139876
Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy
A study testing Open Haemorrhoidectomy and LigaSure Hemorrhoidectomy in people with Hemorrhoids, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Open Haemorrhoidectomy and LigaSure Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 1 Dec 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- The patient has a Haemorrhoidal Symptom Score of 4 or more
- The patient has an American Society of Anaesthesiologists (ASA) score I-II
- The patient's age is 18-85 years at inclusion
- The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
Who cannot join
- The patient has had previous operation for haemorrhoids within the last 2 years
- The patient has had previous operation for anal incontinence
- The patient has an active anal fistula
- The patient has an active anal fissure
- The patient has anal incontinence for solid stools
- Active immunosuppressive therapy (increased risk of anorectal sepsis)
- Cirrhosis / portal hypertension
- Mb Crohn.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Departement of Surgery, Holbaek County Hospital.
Holbæk, 4300
Andre H Campos, MD, 004559484000, ahca@regionsjaelland.dk
Per Olov Gunnar Olaison, MD, pHD, 004559484000, poo@regionsjaelland.dk
About this study
Official title: Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms
This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS).
Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence.
Read the detailed description
Background
Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids is found as early as 2250 Before Christ (BC) in the code of king Hammurabi in Babylon. Even though first recorded treatment is thought to be found in the "Edwin Smith Papyrus" from 1700 BC as of today the treatment of this benign state is still debated. A wide range of prevalence rates of hemorrhoids have been stated in part because of the varying definition ,but the general consensus is that hemorrhoidal disease is a common anorectal disease affecting the quality of life of millions of people worldwide. Operation for hemorrhoid is one of the most common operations for benign disease in Denmark.
Hemorrhoids arise from the normal vascular structures in the anal canal also referred to as anal cushions or sinusoids as they do not contain muscular cells like arteries or veins. These cushions are typically arranged in three main columns or piles in the anal canal forming an important part of the intricate mechanism of the anal canal preventing incontinence.
Hemorrhoids is a pathologic term describing the symptomatic abnormal downward displacement and enlargement of the anal cushions. The term hemorrhoidal disease is used when the hemorrhoids cause symptoms.
Treatment of hemorrhoidal disease consists of conservative management with lifestyle and diet changes or local treatment, minor surgery and surgical treatment depending on the severity of disease and symptoms. The staging of internal hemorrhoids in four categories by the Goligher classification is the classification that generally forms the basis of the treatment in Denmark.
Local treatment consists of corticosteroids and anaesthetic ointments. Minor surgery includes rubber band ligation and sclerotherapy. Operation is reserved for subjects with prolapse, Goligher grade II and IV. Grade II hemorrhoids may be treated by operation if still symptomatic after banding or sclerosing.
The gold standard in the operative treatment of hemorrhoidal is the Milligan-Morgan Hemorrhoidectomy also referred to as hemorrhoidal excision or Open Hemorrhoidectomy (OH). The operation can also be performed as a Closed Hemorrhoidectomy when the wound is closed with sutures (Ferguson's Hemorrhoidectomy).
The conventional excisional operation has been associated with postprocedural pain and delayed healing of wounds. In recent years there have been suggestions for and a development toward a less traumatic Open Hemorrhoidectomy. Injuries to the internal anal sphincter during dissection is thought to be one cause for pain. The less traumatic operations include dissection of the hemorrhoid preserving the fascia over the internal anal sphincter and also smaller excision of skin and mucosa - the technique used in this study is described in more detail under Methods.
Several new procedures have been proposed in the last decades. Common for all is the implementation of a new technical device, meaning increased operative costs.
LigaSure Trademark (TM) hemorrhoidectomy (LH) is a hemorrhoidectomy performed with the use of the LigaSure TM instrument in stead of the traditional diathermy. The LigaSure TM technology patented in 1998 as "Energy Delivery System for Vessel Sealing" creates vessel fusion by a combination of pressure and energy17. The LigaSure device excises the hemorrhoids and seals the wound in the same procedure delivering the energy in a controlled way between the diathermy forceps theoretically limiting thermal spray and tissue charring.
Rationale
Hemorrhoidal Disease is a benign disease and should be evaluated by it's effect on hemorrhoidal symptoms together with its effect on quality of life.
Hemorrhoidal symptoms should be the main outcome variable when evaluating surgery for hemorrhoidal disease. This information is largely lacking.
The use of a validated symptom score with long term follow-up could yield important information for the choice of treatment of haemorrhoidal disease.
- Conditions
- Hemorrhoids
- Being tested
- Open Haemorrhoidectomy, LigaSure Hemorrhoidectomy
- Keywords
- Hemorrhoidectomy, Minimal Open hemorrhoidectomy, LigaSure hemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open HaemorrhoidectomyProcedure or surgery
Also called Milligan Morgan, Minimal open Hemorrhoidectomy, Hemorrhoidectomy
Patient operated in the lithotomy position. The external components are grasped by clamps using gentle traction. Diathermy is used for dissection and hemostasis. The skin is incised midway to one-third of the distance from the top of the pedicle, thus, minimizing the skin excision. The subdermal fascia continuing into a submucosal fascia covering the internal anal sphincter is identified as are fibers passing between the hemorrhoid (H) and this fascia. The H is dissected free from the underlying internal sphincter in this plane, leaving the sphincter unharmed. The anal mucosa is incised at the transition from anal mucosa to hemorrhoidal mucosa and only anal mucosa overlying the H is excised. Only the caudal part of the H is excised. With the H held with gentle traction it is divided at the anal orifice. There will thus be a residual part of the H intra-anally with its caudal end 1-2 cm proximal to the anal orifice.
LigaSure HemorrhoidectomyProcedure or surgery
Patient is operated in the lithotomy position. The main haemorrhoidal (H) masses are identified and delineated. The H are prolapsed out from the anal canal with Allis clamps or similar pick up forceps. Tension is applied to visualise the junction between the nodule and the mucosal wall (internal) or the perianal tissue (external). A small V-shaped anodermal seal is performed by applying the LigaSure (LS) forceps close to the edge of each pile. The seal is then transacted with scissors along the line of coagulum. Care should be taken to limit the amount of tissue removed to minimize the stricture risk. Repeated applications of the device are performed and the excision is continued into the anal canal, lifting the pile from the internal anal sphincter to the level of the vascular pedicle that is finally sealed by LS and divided.
| Study group | Role | What they receive |
|---|---|---|
| Minimal open hemorrhoidectomy | Active comparator | Patients randomized to Minimal open hemorrhoidectomy Receives: Procedure: Open Haemorrhoidectomy |
| LigaSure hemorrhoidectomy | Active comparator | Patients randomized to LigaSure hemorrhoidectomy Receives: Procedure: LigaSure Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).
The HDSS consists of five items on patient-reported frequency of pain, itching, bleeding, soiling and prolapse. Each symptom graded on a five-point scale (0=never, 1=less than once a month, 2=less than once a week, 3=1-6 days per week, 4=every day / always), giving a total score ranging from 0-20. Zero meaning no symptoms. (See reference).
Measured: 1 year postoperatively
Secondary outcomes (4)
Patient satisfaction assessed by a seven grade Likert Scale.
At follow-up patients grade their satisfaction with the operation on a seven-point Likert scale (1= very unsatisfied, 7 = very satisfied).
Measured: Preoperatively (baseline) and 1 year postoperatively
Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD).
SHSHD consist of four questions graded on a 7-point Likert scale. The questions deal with how the patients symptoms caused by hemorrhoids affect the patients daily life.
- - Overall symptom load (1 = no symptoms, 7 = severe symptoms),
- - Interference with daily activities (1 = not at all, 7 = interfere to a very high degree)
- - Worries caused by HD (1 = no concerns, 7 = constant concerns)
- - General well-being (1 = very good, 7 = very bad) The points of each question are summed giving a total score ranging from 4 to 28. (See reference).
Measured: Preoperatively (baseline) and 1 year postoperatively
Anal continence (gas and solids) assessed by the Wexner incontinence scale.
Wexner incontinence scale consists of five questions on fecal incontinence graded on a five-point Likert scale from 0 to 4.
The points of each question are summed giving a total score ranging from 0 to 20. Zero meaning no incontinence and 20 complete incontinence.
Measured: Preoperatively (baseline) and 1 year postoperatively
Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS).
RFIS consists of five questions on fecal incontinence graded on a five-point Likert scale from 0 to 4. The points of each question are summed giving a total score ranging from 0 to 20. Zero meaning no fecal incontinence and twenty total fecal incontinence.
Measured: Preoperatively (baseline) and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Mar 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- Prospective Randomized Study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Heiner dos Santos Campos, Holbaek Sygehus
- Investigators
- Per Olov Gunnar Olaison, MD, pHD, Study director, Department of Surgery, Holbaek County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139876
- Sponsor's protocol ID
- Holbaek
- Status last verified
- Apr 2022
- First submitted
- 4 Oct 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
PubMed 30451751
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy. A Randomized Clinical Trial on the Long-term Effect on Hemorrhoidal Symptoms
- ClinicalTrials.gov ID
- NCT04139876
- Acronym / sponsor ID
- Holbaek
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoidectomy, Minimal Open hemorrhoidectomy, LigaSure hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 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.
This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS).
Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence.
Detailed description
Background
Hemorrhoids is one of the oldest known medical conditions. Description of hemorrhoids is found as early as 2250 Before Christ (BC) in the code of king Hammurabi in Babylon. Even though first recorded treatment is thought to be found in the "Edwin Smith Papyrus" from 1700 BC as of today the treatment of this benign state is still debated. A wide range of prevalence rates of hemorrhoids have been stated in part because of the varying definition ,but the general consensus is that hemorrhoidal disease is a common anorectal disease affecting the quality of life of millions of people worldwide. Operation for hemorrhoid is one of the most common operations for benign disease in Denmark.
Hemorrhoids arise from the normal vascular structures in the anal canal also referred to as anal cushions or sinusoids as they do not contain muscular cells like arteries or veins. These cushions are typically arranged in three main columns or piles in the anal canal forming an important part of the intricate mechanism of the anal canal preventing incontinence.
Hemorrhoids is a pathologic term describing the symptomatic abnormal downward displacement and enlargement of the anal cushions. The term hemorrhoidal disease is used when the hemorrhoids cause symptoms.
Treatment of hemorrhoidal disease consists of conservative management with lifestyle and diet changes or local treatment, minor surgery and surgical treatment depending on the severity of disease and symptoms. The staging of internal hemorrhoids in four categories by the Goligher classification is the classification that generally forms the basis of the treatment in Denmark.
Local treatment consists of corticosteroids and anaesthetic ointments. Minor surgery includes rubber band ligation and sclerotherapy. Operation is reserved for subjects with prolapse, Goligher grade II and IV. Grade II hemorrhoids may be treated by operation if still symptomatic after banding or sclerosing.
The gold standard in the operative treatment of hemorrhoidal is the Milligan-Morgan Hemorrhoidectomy also referred to as hemorrhoidal excision or Open Hemorrhoidectomy (OH). The operation can also be performed as a Closed Hemorrhoidectomy when the wound is closed with sutures (Ferguson's Hemorrhoidectomy).
The conventional excisional operation has been associated with postprocedural pain and delayed healing of wounds. In recent years there have been suggestions for and a development toward a less traumatic Open Hemorrhoidectomy. Injuries to the internal anal sphincter during dissection is thought to be one cause for pain. The less traumatic operations include dissection of the hemorrhoid preserving the fascia over the internal anal sphincter and also smaller excision of skin and mucosa - the technique used in this study is described in more detail under Methods.
Several new procedures have been proposed in the last decades. Common for all is the implementation of a new technical device, meaning increased operative costs.
LigaSure Trademark (TM) hemorrhoidectomy (LH) is a hemorrhoidectomy performed with the use of the LigaSure TM instrument in stead of the traditional diathermy. The LigaSure TM technology patented in 1998 as "Energy Delivery System for Vessel Sealing" creates vessel fusion by a combination of pressure and energy17. The LigaSure device excises the hemorrhoids and seals the wound in the same procedure delivering the energy in a controlled way between the diathermy forceps theoretically limiting thermal spray and tissue charring.
Rationale
Hemorrhoidal Disease is a benign disease and should be evaluated by it's effect on hemorrhoidal symptoms together with its effect on quality of life.
Hemorrhoidal symptoms should be the main outcome variable when evaluating surgery for hemorrhoidal disease. This information is largely lacking.
The use of a validated symptom score with long term follow-up could yield important information for the choice of treatment of haemorrhoidal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Study
| Arm | Type | Receives |
|---|---|---|
| Minimal open hemorrhoidectomy | Active comparator | Procedure: Open HaemorrhoidectomyPatients randomized to Minimal open hemorrhoidectomy |
| LigaSure hemorrhoidectomy | Active comparator | Procedure: LigaSure HemorrhoidectomyPatients randomized to LigaSure hemorrhoidectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- The patient has a Haemorrhoidal Symptom Score of 4 or more
- The patient has an American Society of Anaesthesiologists (ASA) score I-II
- The patient's age is 18-85 years at inclusion
- The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
Key exclusion criteria (8 listed)
- The patient has had previous operation for haemorrhoids within the last 2 years
- The patient has had previous operation for anal incontinence
- The patient has an active anal fistula
- The patient has an active anal fissure
- The patient has anal incontinence for solid stools
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 |
|---|---|---|
| Open HaemorrhoidectomyAlso: Milligan Morgan, Minimal open Hemorrhoidectomy, HemorrhoidectomyPatient operated in the lithotomy position. The external components are grasped by clamps using gentle traction. Diathermy is used for dissection and hemostasis. The skin is incised midway to one-third of the distance from the top of the pedicle, thus, minimizing the skin excision. The subdermal fascia continuing into a submucosal fascia covering the internal anal sphincter is identified as are fibers passing between the hemorrhoid (H) and this fascia. The H is dissected free from the underlying internal sphincter in this plane, leaving the sphincter unharmed. The anal mucosa is incised at the transition from anal mucosa to hemorrhoidal mucosa and only anal mucosa overlying the H is excised. Only the caudal part of the H is excised. With the H held with gentle traction it is divided at the anal orifice. There will thus be a residual part of the H intra-anally with its caudal end 1-2 cm proximal to the anal orifice. | Procedure or surgery | Minimal open hemorrhoidectomy |
| LigaSure HemorrhoidectomyPatient is operated in the lithotomy position. The main haemorrhoidal (H) masses are identified and delineated. The H are prolapsed out from the anal canal with Allis clamps or similar pick up forceps. Tension is applied to visualise the junction between the nodule and the mucosal wall (internal) or the perianal tissue (external). A small V-shaped anodermal seal is performed by applying the LigaSure (LS) forceps close to the edge of each pile. The seal is then transacted with scissors along the line of coagulum. Care should be taken to limit the amount of tissue removed to minimize the stricture risk. Repeated applications of the device are performed and the excision is continued into the anal canal, lifting the pile from the internal anal sphincter to the level of the vascular pedicle that is finally sealed by LS and divided. | Procedure or surgery | LigaSure hemorrhoidectomy |
Primary outcome
Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS).
Time frame: 1 year postoperatively
The HDSS consists of five items on patient-reported frequency of pain, itching, bleeding, soiling and prolapse. Each symptom graded on a five-point scale (0=never, 1=less than once a month, 2=less than once a week, 3=1-6 days per week, 4=every day / always), giving a total score ranging from 0-20. Zero meaning no symptoms. (See reference).
4 secondary outcomes
Patient satisfaction assessed by a seven grade Likert Scale.
Time frame: Preoperatively (baseline) and 1 year postoperatively
Hemorrhoidal affection of the patient's daily life assessed by Short Health Scale adapted to hemorrhoidal disease (SHSHD).
Time frame: Preoperatively (baseline) and 1 year postoperatively
Anal continence (gas and solids) assessed by the Wexner incontinence scale.
Time frame: Preoperatively (baseline) and 1 year postoperatively
Fecal continence assessed by the Revised Fecal Incontinence Scale (RFIS).
Time frame: Preoperatively (baseline) and 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 30451751Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
- Individual participant dataSharing planned: No
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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.
Per Olov Gunnar Olaison, MD, pHD study director
Department of Surgery, Holbaek County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Haemorrhoidectomy and LigaSure Hemorrhoidectomy in people with Hemorrhoids, run by Holbaek Sygehus at 1 site in Denmark.
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 5 inclusion and 8 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 19 Apr 2022. 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 Denmark. 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 Andre H Campos, MD (004559484000, ahca@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhoidal symptoms assessed by the Hemorrhoidal Disease Symptom Score (HDSS). (time frame: 1 year postoperatively). 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 NCT04139876, which also lists 1 linked publication.
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 19 Apr 2022.