Pain, PostoperativePhase 4ICETNCT03052816
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
A Phase 4 study testing Ice T and Motrin/Percocet/Dilaudid for breakthrough in people with Pain, Postoperative and Pelvic Organ Prolapse, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pelvic Organ Prolapse
- What is being tested?
- Ice T and Motrin/Percocet/Dilaudid for breakthrough
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria are the following:
- Consenting, English speaking women between ages 18 and 80 who will undergo same day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
- Ability to read VAS Scores
- Specific vaginal procedures include, but are not limited to:
- Periurethral bulking
- Perineoplasty
Show all 27Show fewer
- Complete vaginectomy
- Le Forte colpocleisis
- Anterior repair
- Posterior repair
- Enterocele repair
- Anterior and posterior repair
- Anterior, posterior and enterocele repair
- Transvaginal mesh use
- Sacrospinous ligament fixation
- Uterosacral ligament suspension
- Vaginal paravaginal defect repair
- Midurethral Sling
- Sphincteroplasty
- Vaginal hysterectomy, for uterus 250 g or less
- Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s)
- Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele
- Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele
- Vaginal hysterectomy, for uterus greater than 250 g
- Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s)
- Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele
- Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele
Who cannot join
- The exclusion criteria are the following:
- History of chronic pelvic pain
- Abdominal surgery
- Laparoscopic surgery
- History of psychiatric disease
- Currently taking analgesic medications
Show all 21Show fewer
- Currently taking sedatives
- Liver disease
- Renal disease with CrCl < 60cc/min.
- History of burns from application of ice.
- Women who did not consent for the study.
- Intraoperative concern for increased blood loss
- Unable to speak English
- Unable to understand VAS Scores
- Undergoing concomitant abdominal or laparoscopic procedures.
- Allergy to motrin, toradol, Percocet, Tylenol
- Active or history of peptic ulcer disease
- History of GI bleeding or perforation
- Hemorrhagic diathesis
- Severe uncontrolled heart failure
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
Read the detailed description
Pelvic floor disorders involve a myriad of complicated, interwoven clinical conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, and other pathology involving the genital and lower urinary tract. It is estimated that pelvic floor disorders affect up to 25% of all adult women in the United States with increasing prevalence with age. By the age of sixty, 1 in 9 women will undergo surgical intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age of 80. As the population in the United States ages, the demand for healthcare for pelvic floor disorders is estimated to increase up to 40% in the next 30 years.
Despite the prevalence of surgery performed for pelvic floor disorders, there is a paucity of data on postoperative pain control that is dedicated to female pelvic reconstructive surgery. In a recent review, there was only one study that evaluated postoperative pain control after vaginal reconstructive surgery, and the mainstay of therapy was opioid driven. Generally, postoperative pain control in gynecologic surgery has been opioid driven, frequently involving multiple narcotics for analgesia, resulting opioid related complications, including nausea, vomiting, constipation, urinary retention, and central nervous system side effects In an effort to combat opioid use in gynecologic and female pelvic reconstructive surgery, multimodal therapy has been gaining momentum with goals of improved pain control and decreased opioid requirements. Ice packs, toradol, and acetaminophen have been used in various trials to decrease postoperative opioid requirements in various surgeries.
Ice packs have been shown to be effective in the treatment of postoperative pain after abdominal midline incisions. A Cochrane Review of patients subject to post vaginal delivery perineal cooling included 10 randomized controlled trials with1825 patients with some evidence that local cooling in the form of ice packs, cold gel packs, cold/ice backs may be effective in pain relief.
Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic. It has been administered preemptively, intraoperatively, and postoperatively for pain control with evidence that toradol decreases postoperative subjective pain scores and decreased narcotic use.
Acetaminophen is mainstay for postoperative pain control as part of multimodal pain regimens to complement other, opioid sparing medications in a multitude of surgeries including abdominal hysterectomy.
Therefore, the purpose of this randomized controlled study is to determine whether, "ICE-T" a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control and decrease opioid intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
- Conditions
- Pain, Postoperative, Pelvic Organ Prolapse
- Being tested
- Ice T, Motrin/Percocet/Dilaudid for breakthrough
- Medical subject headings
- Pain, Postoperative, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice TDrug
Ice/Tylenol/Toradol with dilaudid for breakthrough
Motrin/Percocet/Dilaudid for breakthroughDrug
Standard regimen
| Study group | Role | What they receive |
|---|---|---|
| ICE T | Experimental | 1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN. Receives: Drug: Ice T |
| Standard | Active comparator | 1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN. Receives: Drug: Motrin/Percocet/Dilaudid for breakthrough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scores (VAS)
Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Measured: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
Secondary outcomes (9)
VAS Scores at 4 Hours Post Surgery
VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Measured: VAS Scores at 4 hours post surgery
VAS Scores 96 Hours After Surgery
VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Measured: VAS Scores 96 hours after surgery
Quality of Recovery Scores on Post op Day 1
Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.
Measured: Quality of Recovery scores on post op day 1
Satisfaction Scores in the Morning After Surgery (7AM)
Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Measured: Satisfaction scores in the morning after surgery (7AM)
Satisfaction Scores 96 Hours After Surgery
Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Measured: Satisfaction scores 96 hours after surgery
Length of Stay
Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.
Measured: Time from end of surgery to discharge home from hospital, assessed up to 1 week.
Total Dose of Opioids Administered During Hospitalization
Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.
Measured: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week
Postoperative Nausea and Vomiting at 7AM After Surgery
Number of patients with postoperative nausea and vomiting at 7AM after surgery
Measured: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery
Number of Participants With Urinary Retention.
Number of participants with urinary retention (discharge home with foley)
Measured: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Apr 2017
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052816
- Sponsor's protocol ID
- 16-00498
- Acronym
- ICET
- Status last verified
- Oct 2021
- First submitted
- 31 Jan 2017
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
PubMed 31201808
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03052816
- Acronym / sponsor ID
- ICET / 16-00498
- Conditions
- Pain, Postoperative, Pelvic Organ Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
Detailed description
Pelvic floor disorders involve a myriad of complicated, interwoven clinical conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, and other pathology involving the genital and lower urinary tract. It is estimated that pelvic floor disorders affect up to 25% of all adult women in the United States with increasing prevalence with age. By the age of sixty, 1 in 9 women will undergo surgical intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age of 80. As the population in the United States ages, the demand for healthcare for pelvic floor disorders is estimated to increase up to 40% in the next 30 years.
Despite the prevalence of surgery performed for pelvic floor disorders, there is a paucity of data on postoperative pain control that is dedicated to female pelvic reconstructive surgery. In a recent review, there was only one study that evaluated postoperative pain control after vaginal reconstructive surgery, and the mainstay of therapy was opioid driven. Generally, postoperative pain control in gynecologic surgery has been opioid driven, frequently involving multiple narcotics for analgesia, resulting opioid related complications, including nausea, vomiting, constipation, urinary retention, and central nervous system side effects In an effort to combat opioid use in gynecologic and female pelvic reconstructive surgery, multimodal therapy has been gaining momentum with goals of improved pain control and decreased opioid requirements. Ice packs, toradol, and acetaminophen have been used in various trials to decrease postoperative opioid requirements in various surgeries.
Ice packs have been shown to be effective in the treatment of postoperative pain after abdominal midline incisions. A Cochrane Review of patients subject to post vaginal delivery perineal cooling included 10 randomized controlled trials with1825 patients with some evidence that local cooling in the form of ice packs, cold gel packs, cold/ice backs may be effective in pain relief.
Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic. It has been administered preemptively, intraoperatively, and postoperatively for pain control with evidence that toradol decreases postoperative subjective pain scores and decreased narcotic use.
Acetaminophen is mainstay for postoperative pain control as part of multimodal pain regimens to complement other, opioid sparing medications in a multitude of surgeries including abdominal hysterectomy.
Therefore, the purpose of this randomized controlled study is to determine whether, "ICE-T" a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control and decrease opioid intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICE T | Experimental | Drug: Ice T1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. 3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with PO Tylenol and PO toradol PRN. |
| Standard | Active comparator | Drug: Motrin/Percocet/Dilaudid for breakthrough1. Motrin 600mg PO Q4h PRN pain 1-3 2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain 3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- The inclusion criteria are the following:
- Consenting, English speaking women between ages 18 and 80 who will undergo same day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
- Ability to read VAS Scores
- Specific vaginal procedures include, but are not limited to:
Key exclusion criteria (21 listed)
- The exclusion criteria are the following:
- History of chronic pelvic pain
- Abdominal surgery
- Laparoscopic surgery
- History of psychiatric disease
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 |
|---|---|---|
| Ice TIce/Tylenol/Toradol with dilaudid for breakthrough | Drug | ICE T |
| Motrin/Percocet/Dilaudid for breakthroughStandard regimen | Drug | Standard |
Primary outcome
Visual Analog Scores (VAS)
Time frame: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
9 secondary outcomes
VAS Scores at 4 Hours Post Surgery
Time frame: VAS Scores at 4 hours post surgery
VAS Scores 96 Hours After Surgery
Time frame: VAS Scores 96 hours after surgery
Quality of Recovery Scores on Post op Day 1
Time frame: Quality of Recovery scores on post op day 1
Satisfaction Scores in the Morning After Surgery (7AM)
Time frame: Satisfaction scores in the morning after surgery (7AM)
Satisfaction Scores 96 Hours After Surgery
Time frame: Satisfaction scores 96 hours after surgery
Length of Stay
Time frame: Time from end of surgery to discharge home from hospital, assessed up to 1 week.
Total Dose of Opioids Administered During Hospitalization
Time frame: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week
Postoperative Nausea and Vomiting at 7AM After Surgery
Time frame: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery
Number of Participants With Urinary Retention.
Time frame: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31201808Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ice T and Motrin/Percocet/Dilaudid for breakthrough in people with Pain, Postoperative and Pelvic Organ Prolapse, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 27 inclusion and 21 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 19 May 2023. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scores (VAS) (time frame: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.). 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 NCT03052816, 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 May 2023.