Rectal ProlapseNCT04893642
Swedish Rectal Prolapse Trial
A study testing Suture rectopexy, resection rectopexy and Delorme's operation in people with Rectal Prolapse, run by Danderyd Hospital at 12 sites in Sweden.
Trial summary
Rectal prolapse is a medical condition where rectum is protruding through the anal opening. The treatment is by surgery that can be performed with an anterior approach through the abdomen or a posterior perineal approach. The condition is more common in elderly patients and much more common in women compared to men. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Suture rectopexy, resection rectopexy and Delorme's operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 12 sitesSweden
- Study dates
- 23 Mar 2000to 1 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete rectal prolapse
- Informed consent
- Surgical correction is considered appropriate
- Capable to participate in follow-up visits and answering questionnaires
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Sweden12 sites
Sahlgrenska University Hospital
Gothenburg
Karlstad Central Hospital
Karlstad
Linköping University Hospital
Linköping
Sunderbyn Hopsital
Luleå
Skåne University Hospital
Malmö
Vrinnevi Hospital
Norrköping
Danderyd Hospital
Stockholm, 18150
karolinska Univeristy Hospital Solna
Stockholm
Karolinska University Hospital Huddiinge
Stockholm
Sankt göran hospital
Stockholm
Uddevalla Hospital
Uddevalla
Uppsala University Hospital
Uppsala
About this study
Official title: To Resect or Not Resect - The Randomized Swedish Rectal Prolapse Trial
Rectal prolapse is a medical condition where rectum is protruding through the anal opening. The treatment is by surgery that can be performed with an anterior approach through the abdomen or a posterior perineal approach. The condition is more common in elderly patients and much more common in women compared to men. All used surgical techniques have advantages and disadvantages. The primary aim of this study is to evaluate if an abdominal or perineal surgical approach is best to correct a rectal prolapse. The outcome measures will be validated questionnaires on quality of Life (SF-36) and bowel function (modified Wexner incontinence score) as well as recurrence of the rectal prolapse and surgical complications.
The study is a randomized multicenter trial with a 2x2 factorial design. Patients will be randomized between perineal and abdominal approach in a first randomization and the perineal group will then further be randomized into one of two specific operations (delorme or altemeier) and the abdominal group will be further randomized into suture rectopexy or resection rectopexy.
The patients will be followed for 3 months, 1 year and 3 years and a longterm follow up of up to 17 years for recurrence.
Read the detailed description
Background Full thickness rectal prolapse, or procidentia, is a benign but distressing condition. It is defined as the circumferential protrusion of all layers of the rectal wall through the anal sphincters. The annual incidence is 2,5 per 100 000, predominantly in the elderly, and male-to-female ratio is about 1:6.
More than 100 different procedures have been described for surgical treatment of rectal prolapse and consensus has not yet been reached. Traditionally, perineal procedures have been reserved for older patients who are not fit for an abdominal operation. The two most common perineal procedures are Delorme's operation, i.e. mucosectomy and rectal plication, and perineal rectosigmoidectomy, also known as Altemeier's operation, which is a full-thickness excision of the rectum.
The choices between abdominal vs. perineal approach and resection or not were all addressed in the Swedish rectal prolapse trial with possible differences in bowel function, quality of life, recurrence rate and complications as end points.
Study design and randomization This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. At inclusion, patients signed an informed consent form and the attending surgeon contacted the central trial office at the Danderyd Hospital, Stockholm, Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).
Preoperative evaluation and procedures All patients were clinically examined and diagnosed with full thickness rectal prolapse. Further examinations with endoscopy, colon transit studies, anorectal manometry, defecography, endoanal ultrasound and pudendal nerve motor latency were optional and were performed as indicated at each surgeon's discretion. Operative procedures were described in the study protocol, see appendix. Abdominal procedures were performed laparoscopically or as open procedure.
In order to validate data all questionnaires were gathered at the central trial hospital and inspected by a second researcher.
The surgical procedures were identified and standardized to a large extent. Both minimal invasive and open surgery were allowed. For example the abdominal procedures were described that mobilization of rectum should be done in the posterior aspect, the lateral ligaments should not be divided, Suture rectopexy should be done with non-absorbable 0.0 sutures, the cul de sac should not be closed.
The sample size was calculated to 220 patients in the first randomization between abdominal and perineal approach. With 220 patients a difference in recurrence of 13% could be identified with 90% power in a significance level of 5%. The plan was to analyze the categorical variables with either Fisher´s exact test or multivariate analysis.
A main study office was situated at Danderyd Hospital and randomization was done from this office at the time when the patient was scheduled for surgery. All hospitals performing surgery for rectal prolapses in Sweden were invited to the study.
- Conditions
- Rectal Prolapse
- Being tested
- Suture rectopexy, resection rectopexy, Delorme's operation, Altemeier's operation
- Keywords
- Randomized controlled study, Multicenter, Prospective
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture rectopexyProcedure or surgery
resection rectopexyProcedure or surgery
Delorme's operationProcedure or surgery
Altemeier's operationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Abdominal suture rectopexy | Active comparator | Patients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy. Receives: Procedure: Suture rectopexy |
| Abdominal resection rectopexy | Active comparator | Patients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy. Receives: Procedure: resection rectopexy |
| Perineal Delorme | Active comparator | Patients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation. Receives: Procedure: Delorme's operation |
| Perineal Altemeier | Active comparator | Patients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation. Receives: Procedure: Altemeier's operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel function
Wexner incontinence score, points, 0-20, higher worse result
Measured: 3 months
Bowel function
Wexner incontinence score, points, 0-20, higher worse result
Measured: 1 year
Bowel function
Wexner incontinence score, points, 0-20, higher worse result
Measured: 3 years
Quality of Life
SF-36, points, 0-100 points, higher better result
Measured: 3 months
Quality of Life
SF-36, points, 0-100 points, higher better result
Measured: 1 year
Quality of Life
SF-36, points, 0-100 points, higher better result
Measured: 3 years
Secondary outcomes (4)
Recurrence of rectal prolapse
recurrence at outpatient visits
Measured: 3 months
Recurrence of rectal prolapse
recurrence at outpatient visits
Measured: 1 year
Recurrence of rectal prolapse
recurrence at outpatient visits
Measured: 3 years
Recurrence of rectal prolapse
Recurrence in Medical records
Measured: through study completion, an average of 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start23 Mar 2000
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: The study had planned to recruit 220 but was termianted in advance when 134 patients were randomized. This was done due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal ProlapseStudies 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
- Factorial
- Model description
- This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Klas Pekkari, Danderyd Hospital
- Investigators
- Fredrik Hjern, Ass Prof, MD, Principal investigator, Danderyd HospitalKlas Pekkari, Md PhD, Study director, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893642
- Sponsor's protocol ID
- swedishrectalprolapse
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD001758. doi: 10.1002/14651858.CD001758.pub3.
PubMed 26599079Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg. 2005;94(3):207-10. doi: 10.1177/145749690509400306.
PubMed 16259169Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse. Arch Surg. 2005 Jan;140(1):63-73. doi: 10.1001/archsurg.140.1.63.
PubMed 15655208Lundby L, Iversen LH, Buntzen S, Wara P, Hoyer K, Laurberg S. Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study. Lancet Gastroenterol Hepatol. 2016 Dec;1(4):291-297. doi: 10.1016/S2468-1253(16)30085-1. Epub 2016 Oct 4.
PubMed 28404199Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.
PubMed 23461778Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
PubMed 29757320Smedberg J, Graf W, Pekkari K, Hjern F. Comparison of four surgical approaches for rectal prolapse: multicentre randomized clinical trial. BJS Open. 2022 Jan 6;6(1):zrab140. doi: 10.1093/bjsopen/zrab140.
PubMed 35045155
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Resect or Not Resect - The Randomized Swedish Rectal Prolapse Trial
- ClinicalTrials.gov ID
- NCT04893642
- Acronym / sponsor ID
- swedishrectalprolapse
- Conditions
- Rectal Prolapse
- Keywords
- Randomized controlled study, Multicenter, Prospective
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study had planned to recruit 220 but was termianted in advance when 134 patients were randomized. This was done due to slow recruitment.
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 23 Mar 2000 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 19 May 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.
Rectal prolapse is a medical condition where rectum is protruding through the anal opening. The treatment is by surgery that can be performed with an anterior approach through the abdomen or a posterior perineal approach. The condition is more common in elderly patients and much more common in women compared to men. All used surgical techniques have advantages and disadvantages. The primary aim of this study is to evaluate if an abdominal or perineal surgical approach is best to correct a rectal prolapse. The outcome measures will be validated questionnaires on quality of Life (SF-36) and bowel function (modified Wexner incontinence score) as well as recurrence of the rectal prolapse and surgical complications.
The study is a randomized multicenter trial with a 2x2 factorial design. Patients will be randomized between perineal and abdominal approach in a first randomization and the perineal group will then further be randomized into one of two specific operations (delorme or altemeier) and the abdominal group will be further randomized into suture rectopexy or resection rectopexy.
The patients will be followed for 3 months, 1 year and 3 years and a longterm follow up of up to 17 years for recurrence.
Detailed description
Background Full thickness rectal prolapse, or procidentia, is a benign but distressing condition. It is defined as the circumferential protrusion of all layers of the rectal wall through the anal sphincters. The annual incidence is 2,5 per 100 000, predominantly in the elderly, and male-to-female ratio is about 1:6.
More than 100 different procedures have been described for surgical treatment of rectal prolapse and consensus has not yet been reached. Traditionally, perineal procedures have been reserved for older patients who are not fit for an abdominal operation. The two most common perineal procedures are Delorme's operation, i.e. mucosectomy and rectal plication, and perineal rectosigmoidectomy, also known as Altemeier's operation, which is a full-thickness excision of the rectum.
The choices between abdominal vs. perineal approach and resection or not were all addressed in the Swedish rectal prolapse trial with possible differences in bowel function, quality of life, recurrence rate and complications as end points.
Study design and randomization This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. At inclusion, patients signed an informed consent form and the attending surgeon contacted the central trial office at the Danderyd Hospital, Stockholm, Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).
Preoperative evaluation and procedures All patients were clinically examined and diagnosed with full thickness rectal prolapse. Further examinations with endoscopy, colon transit studies, anorectal manometry, defecography, endoanal ultrasound and pudendal nerve motor latency were optional and were performed as indicated at each surgeon's discretion. Operative procedures were described in the study protocol, see appendix. Abdominal procedures were performed laparoscopically or as open procedure.
In order to validate data all questionnaires were gathered at the central trial hospital and inspected by a second researcher.
The surgical procedures were identified and standardized to a large extent. Both minimal invasive and open surgery were allowed. For example the abdominal procedures were described that mobilization of rectum should be done in the posterior aspect, the lateral ligaments should not be divided, Suture rectopexy should be done with non-absorbable 0.0 sutures, the cul de sac should not be closed.
The sample size was calculated to 220 patients in the first randomization between abdominal and perineal approach. With 220 patients a difference in recurrence of 13% could be identified with 90% power in a significance level of 5%. The plan was to analyze the categorical variables with either Fisher´s exact test or multivariate analysis.
A main study office was situated at Danderyd Hospital and randomization was done from this office at the time when the patient was scheduled for surgery. All hospitals performing surgery for rectal prolapses in Sweden were invited to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This was a multicenter randomized trial with a 2 x 2 factorial design conducted in 13 sites in Sweden. Randomization was performed with randomly assigned envelopes, stratified for each participating center. Patients were randomized between perineal and abdominal approach (A). The perineal group was further randomized to Delorme's or Altemeier's procedure (B) and the abdominal group to suture rectopexy or resection rectopexy (C). Patients who were considered unsuitable for random allocation to a perineal or an abdominal procedure were included only in (B) or (C).
| Arm | Type | Receives |
|---|---|---|
| Abdominal suture rectopexy | Active comparator | Procedure: Suture rectopexyPatients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy. |
| Abdominal resection rectopexy | Active comparator | Procedure: resection rectopexyPatients were randomized first into either an abdominal or a perineal approach. The abdominal group was then further randomized to suture rectopexy or resection rectopexy. |
| Perineal Delorme | Active comparator | Procedure: Delorme's operationPatients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation. |
| Perineal Altemeier | Active comparator | Procedure: Altemeier's operationPatients were randomized first into either an abdominal or a perineal approach. The perineal group was then further randomized to Delorme's operation or Altemeier's operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complete rectal prolapse
- Informed consent
- Surgical correction is considered appropriate
- Capable to participate in follow-up visits and answering questionnaires
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Suture rectopexy | Procedure or surgery | Abdominal suture rectopexy |
| resection rectopexy | Procedure or surgery | Abdominal resection rectopexy |
| Delorme's operation | Procedure or surgery | Perineal Delorme |
| Altemeier's operation | Procedure or surgery | Perineal Altemeier |
Primary outcome
Bowel function
Time frame: 3 months
Wexner incontinence score, points, 0-20, higher worse result
Bowel function
Time frame: 1 year
Wexner incontinence score, points, 0-20, higher worse result
Bowel function
Time frame: 3 years
Wexner incontinence score, points, 0-20, higher worse result
Quality of Life
Time frame: 3 months
SF-36, points, 0-100 points, higher better result
Quality of Life
Time frame: 1 year
SF-36, points, 0-100 points, higher better result
Quality of Life
Time frame: 3 years
SF-36, points, 0-100 points, higher better result
4 secondary outcomes
Recurrence of rectal prolapse
Time frame: 3 months
Recurrence of rectal prolapse
Time frame: 1 year
Recurrence of rectal prolapse
Time frame: 3 years
Recurrence of rectal prolapse
Time frame: through study completion, an average of 12 years
Results and safety
The study was stopped early (reason given: The study had planned to recruit 220 but was termianted in advance when 134 patients were randomized. This was done due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 26599079Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD001758. doi: 10.1002/14651858.CD001758.pub3.
- Background: PubMed 16259169Kairaluoma MV, Kellokumpu IH. Epidemiologic aspects of complete rectal prolapse. Scand J Surg. 2005;94(3):207-10. doi: 10.1177/145749690509400306.
- Background: PubMed 15655208Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse. Arch Surg. 2005 Jan;140(1):63-73. doi: 10.1001/archsurg.140.1.63.
- Background: PubMed 28404199Lundby L, Iversen LH, Buntzen S, Wara P, Hoyer K, Laurberg S. Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study. Lancet Gastroenterol Hepatol. 2016 Dec;1(4):291-297. doi: 10.1016/S2468-1253(16)30085-1. Epub 2016 Oct 4.
- Background: PubMed 23461778Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.
- Background: PubMed 29757320Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
- Derived from this study: PubMed 35045155Smedberg J, Graf W, Pekkari K, Hjern F. Comparison of four surgical approaches for rectal prolapse: multicentre randomized clinical trial. BJS Open. 2022 Jan 6;6(1):zrab140. doi: 10.1093/bjsopen/zrab140.
- 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.
Fredrik Hjern, Ass Prof, MD principal investigator
Danderyd Hospital
Klas Pekkari, Md PhD study director
Danderyd Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture rectopexy, resection rectopexy and Delorme's operation in people with Rectal Prolapse, run by Danderyd Hospital at 12 sites in Sweden.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. 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?
The study was stopped early (reason given: The study had planned to recruit 220 but was termianted in advance when 134 patients were randomized. This was done due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT04893642, which also lists 7 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 19 May 2021.