Pelvic Organ ProlapseNCT04852991
Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy
A study testing Modified Purandare cervicopexy and Abdominal sacral hysteropexy in people with Pelvic Organ Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study aims to compare safety, efficacy and complications of modified Purandare's cervicopexy with abdominal sacral hysteropexy as conservative surgery in the treatment of genital prolapse in reproductive age group patients at Ain Shams Maternity hospital. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Modified Purandare cervicopexy and Abdominal sacral hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 17 Aug 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age : 20 years - 40 years
- BMI: 20 to 35 kg\m2
- Any parity with desire for future pregnancy
Who cannot join
- 1st degree uterine prolapse.
- Previous correction of apical prolapse.
- Co-existing uterine pathology e.g. uterine fibroid .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial
This study aims to compare safety, efficacy and complications of modified Purandare's cervicopexy with abdominal sacral hysteropexy as conservative surgery in the treatment of genital prolapse in reproductive age group patients at Ain Shams Maternity hospital.
Read the detailed description
Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality. Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse . The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits .
Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% . In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made.
The core of the modified purandare's cervicopexy is fixation of the uterine isthmus by a 25-30 cm long strip of polypropylene mesh to the rectus muscle by criss crossing using No. 1 polypropylene sutures.
Modified purandare's cervicopexy is easy to perform and provides dynamic support to the uterus, improves fertility, doesn't interfere with vaginal birth and if caesarean delivery is required doesn't damage the mesh thus reducing the recurrence of prolapse and has many advantages compared to the original operation which can favourably affect the outcome, such as: criss crossing of mesh on rectus muscle which provides a space for low transverse incision for caesarean section without compromising the mesh anchoring and retaining the support. This surgery is technically easy to perform and complications like Periosteitis, ureteric and sigmoid injuries are avoided.
Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Modified Purandare cervicopexy, Abdominal sacral hysteropexy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Purandare cervicopexyProcedure or surgery
The modified Purandare's cervicopexy will be performed in low lithotomy position . Pfannenstiel incision was utilized and the abdomen was opened in layers maintaining perfect hemostasis. Uterus will be delivered through the incision and held with uterus holding forceps. The bladder was dissected inferiorly. A 25-30 cm long strip of polypropylene mesh was prepared by soaking. The mesh was fixed anteriorly at the level of isthmus by No.1 polypropylene sutures . The ends of the mesh were brought lateral to rectus muscle retroperitoneally on both sides taking care not to injure the inferior epigastric vessels. After confirming the correct fixation and haemostasis the uterovesical fold of peritoneum was approximated. The ends of the mesh were fixed to the rectus muscle by criss crossing using No. 1 polypropylene sutures. After confirming the haemostasis, the abdomen was closed in layers. Per speculum examination was done to note the reduction of prolapse.
Abdominal sacral hysteropexyProcedure or surgery
After peritoneal entry through pfannenstiel incision was, the bladder is mobilized off the cervix. Windows are made in the broad ligament at the level of the isthmus. Posteriorly, the rectovaginal space is entered at the level of the uterosacral ligaments. Next, a 15x15-cm polypropylene mesh is used to fashion two 4.5- to 5-cm-wide strips of mesh; one is bisected for a distance of 5 cm to produce a Y-configuration for the anterior mesh.The anterior mesh arms are passed through the broad ligament windows and attached to the cervix and pubocervical fascia using interrupted 2-0 PDS. The posterior mesh is attached to the rectovaginal fascia using transverse-interrupted 2-0 PDS sutures. Once the sacral dissection has exposed the anterior longitudinal ligament, the proximal ends of the 2 mesh strips are attached to the sacral promontory using two 2-0 polyester sutures to provide elevation of the uterus without tension. The peritoneum is closed over the mesh using a 3-0 vicryl suture
| Study group | Role | What they receive |
|---|---|---|
| Modified Purandare cervicopexy | Active comparator | Apical prolapse will be corrected by Modified Purandare cervicopexy Receives: Procedure: Modified Purandare cervicopexy |
| Abdominal sacrohysterpexy | Active comparator | Apical prolapse will be corrected by Abdominal sacrohysterpexy Receives: Procedure: Abdominal sacral hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
After the procedure there will be follow up visits at 12 months respectively to detect if there is recurrence or not by history taking and pelvic examination.
Measured: twelve months after the procedure
Secondary outcomes (10)
Operative time
Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Measured: In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Intra operative blood loss
Intraoperative blood loss will be estimated via:
- Amount of blood in suction bottle.
- Estimation based on the number of soaked gauzes by weighing the gauzes used in the procedure before and after surgery ( each 1 mg f corresponds to 1 ml of blood)
- Drop in postoperative hemoglobin and hematocrit when compared with preoperative values
Measured: During the procedure
Need for blood transfusion
number of participants who need blood transfusion
Measured: During the procedure
Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)
- Postoperative pain will be assessed using the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain).
Measured: This will be assessed after 6 hours, 12 hours and 24 hours from the operation
Duration of post operative hospital stay.
Duration of postoperative hospital stay will be measured from the end of the procedure till discharge from hospital and it will be measured in hours
Measured: immediately surgery
Bowel injury
number of participants who suffered from bowel injury during the procedure
Measured: During the procedure
Vascular injury
number of participants who suffered from vascular injury during the procedure
Measured: During the procedure
Subfascial hematoma
number of participants who will suffer from subfascial hematoma
Measured: up to 6 weeks after surgery
urinary tract infection
number of participants who will suffer from urinary tract infection
Measured: up to 6 weeks after surgery
Surgical site infection
number of participants who will suffer from surgical site infection
Measured: up to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start15 Apr 2020
- Primary completion20 Apr 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital
- Investigators
- Mohammed A Nasr Eldeen, MD, Study director, AinShams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852991
- Sponsor's protocol ID
- 4
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lowder JL, Ghetti C, Nikolajski C, Oliphant SS, Zyczynski HM. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol. 2011 May;204(5):441.e1-5. doi: 10.1016/j.ajog.2010.12.024. Epub 2011 Feb 2.
PubMed 21292234Virkud A. Conservative Operations in Genital Prolapse. J Obstet Gynaecol India. 2016 Jun;66(3):144-8. doi: 10.1007/s13224-016-0909-8. Epub 2016 Apr 29.
PubMed 27298521R., Rameshkumar & Kamat, Leena & Tungal, Spoorthi & Moni, Suma. (2017). Modified purandare's cervicopexy-a conservative surgery for genital prolapse: a retrospective study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology. 6. 10.18203/2320-1770.ijrcog20171529.
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
PubMed 20966694Cvach K, Dwyer P. Surgical management of pelvic organ prolapse: abdominal and vaginal approaches. World J Urol. 2012 Aug;30(4):471-7. doi: 10.1007/s00345-011-0776-y. Epub 2011 Oct 22.
PubMed 22020436Cvach K, Geoffrion R, Cundiff GW. Abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy. Female Pelvic Med Reconstr Surg. 2012 Sep-Oct;18(5):286-90. doi: 10.1097/SPV.0b013e3182673772.
PubMed 22983272• Cvach, K. and Cundiff, G. Abdominal Sacral Hysteropexy: Clinical Outcomes Compared to Abdominal Sacral Colpopexy With Concurrent Hysterectomy. Univers. British Columbia (UBC), 2008, 677-678.
Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.
PubMed 16934269Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
PubMed 11129939
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Purandare's Cervicopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04852991
- Acronym / sponsor ID
- 4
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 21 Apr 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.
This study aims to compare safety, efficacy and complications of modified Purandare's cervicopexy with abdominal sacral hysteropexy as conservative surgery in the treatment of genital prolapse in reproductive age group patients at Ain Shams Maternity hospital.
Detailed description
Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality. Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse . The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits .
Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% . In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made.
The core of the modified purandare's cervicopexy is fixation of the uterine isthmus by a 25-30 cm long strip of polypropylene mesh to the rectus muscle by criss crossing using No. 1 polypropylene sutures.
Modified purandare's cervicopexy is easy to perform and provides dynamic support to the uterus, improves fertility, doesn't interfere with vaginal birth and if caesarean delivery is required doesn't damage the mesh thus reducing the recurrence of prolapse and has many advantages compared to the original operation which can favourably affect the outcome, such as: criss crossing of mesh on rectus muscle which provides a space for low transverse incision for caesarean section without compromising the mesh anchoring and retaining the support. This surgery is technically easy to perform and complications like Periosteitis, ureteric and sigmoid injuries are avoided.
Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Purandare cervicopexy | Active comparator | Procedure: Modified Purandare cervicopexyApical prolapse will be corrected by Modified Purandare cervicopexy |
| Abdominal sacrohysterpexy | Active comparator | Procedure: Abdominal sacral hysteropexyApical prolapse will be corrected by Abdominal sacrohysterpexy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age : 20 years - 40 years
- BMI: 20 to 35 kg\m2
- Any parity with desire for future pregnancy
Key exclusion criteria (3 listed)
- 1st degree uterine prolapse.
- Previous correction of apical prolapse.
- Co-existing uterine pathology e.g. uterine fibroid .
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 |
|---|---|---|
| Modified Purandare cervicopexyThe modified Purandare's cervicopexy will be performed in low lithotomy position . Pfannenstiel incision was utilized and the abdomen was opened in layers maintaining perfect hemostasis. Uterus will be delivered through the incision and held with uterus holding forceps. The bladder was dissected inferiorly. A 25-30 cm long strip of polypropylene mesh was prepared by soaking. The mesh was fixed anteriorly at the level of isthmus by No.1 polypropylene sutures . The ends of the mesh were brought lateral to rectus muscle retroperitoneally on both sides taking care not to injure the inferior epigastric vessels. After confirming the correct fixation and haemostasis the uterovesical fold of peritoneum was approximated. The ends of the mesh were fixed to the rectus muscle by criss crossing using No. 1 polypropylene sutures. After confirming the haemostasis, the abdomen was closed in layers. Per speculum examination was done to note the reduction of prolapse. | Procedure or surgery | Modified Purandare cervicopexy |
| Abdominal sacral hysteropexyAfter peritoneal entry through pfannenstiel incision was, the bladder is mobilized off the cervix. Windows are made in the broad ligament at the level of the isthmus. Posteriorly, the rectovaginal space is entered at the level of the uterosacral ligaments. Next, a 15x15-cm polypropylene mesh is used to fashion two 4.5- to 5-cm-wide strips of mesh; one is bisected for a distance of 5 cm to produce a Y-configuration for the anterior mesh.The anterior mesh arms are passed through the broad ligament windows and attached to the cervix and pubocervical fascia using interrupted 2-0 PDS. The posterior mesh is attached to the rectovaginal fascia using transverse-interrupted 2-0 PDS sutures. Once the sacral dissection has exposed the anterior longitudinal ligament, the proximal ends of the 2 mesh strips are attached to the sacral promontory using two 2-0 polyester sutures to provide elevation of the uterus without tension. The peritoneum is closed over the mesh using a 3-0 vicryl suture | Procedure or surgery | Abdominal sacrohysterpexy |
Primary outcome
Recurrence
Time frame: twelve months after the procedure
After the procedure there will be follow up visits at 12 months respectively to detect if there is recurrence or not by history taking and pelvic examination.
10 secondary outcomes
Operative time
Time frame: In minutes from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Intra operative blood loss
Time frame: During the procedure
Need for blood transfusion
Time frame: During the procedure
Postoperative pain the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain)
Time frame: This will be assessed after 6 hours, 12 hours and 24 hours from the operation
Duration of post operative hospital stay.
Time frame: immediately surgery
Bowel injury
Time frame: During the procedure
Vascular injury
Time frame: During the procedure
Subfascial hematoma
Time frame: up to 6 weeks after surgery
urinary tract infection
Time frame: up to 6 weeks after surgery
Surgical site infection
Time frame: up to 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Background: PubMed 21292234Lowder JL, Ghetti C, Nikolajski C, Oliphant SS, Zyczynski HM. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol. 2011 May;204(5):441.e1-5. doi: 10.1016/j.ajog.2010.12.024. Epub 2011 Feb 2.
- Background: PubMed 27298521Virkud A. Conservative Operations in Genital Prolapse. J Obstet Gynaecol India. 2016 Jun;66(3):144-8. doi: 10.1007/s13224-016-0909-8. Epub 2016 Apr 29.
- BackgroundR., Rameshkumar & Kamat, Leena & Tungal, Spoorthi & Moni, Suma. (2017). Modified purandare's cervicopexy-a conservative surgery for genital prolapse: a retrospective study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology. 6. 10.18203/2320-1770.ijrcog20171529.
- Background: PubMed 20966694Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
- Background: PubMed 22020436Cvach K, Dwyer P. Surgical management of pelvic organ prolapse: abdominal and vaginal approaches. World J Urol. 2012 Aug;30(4):471-7. doi: 10.1007/s00345-011-0776-y. Epub 2011 Oct 22.
- Background: PubMed 22983272Cvach K, Geoffrion R, Cundiff GW. Abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy. Female Pelvic Med Reconstr Surg. 2012 Sep-Oct;18(5):286-90. doi: 10.1097/SPV.0b013e3182673772.
- Background• Cvach, K. and Cundiff, G. Abdominal Sacral Hysteropexy: Clinical Outcomes Compared to Abdominal Sacral Colpopexy With Concurrent Hysterectomy. Univers. British Columbia (UBC), 2008, 677-678.
- Background: PubMed 16934269Lapaire O, Schneider MC, Stotz M, Surbek DV, Holzgreve W, Hoesli IM. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. Int J Gynaecol Obstet. 2006 Oct;95(1):2-7. doi: 10.1016/j.ijgo.2006.05.031. Epub 2006 Aug 23.
- Background: PubMed 11129939Hawksley H. Pain assessment using a visual analogue scale. Prof Nurse. 2000 Jun;15(9):593-7.
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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.
Mohammed A Nasr Eldeen, MD study director
AinShams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Purandare cervicopexy and Abdominal sacral hysteropexy in people with Pelvic Organ Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 12 Aug 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence (time frame: twelve months after the procedure). 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 NCT04852991, which also lists 9 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 12 Aug 2022.