Pelvic Organ ProlapseNCT03730103
Same Day Discharge After Minimally-invasive Sacrocolpopexy
A study testing Same day discharge in people with Pelvic Organ Prolapse, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a prospective cohort study evaluating safety, cost and patient satisfaction with SDD for patients undergoing minimally invasive sacrocolpopexy for pelvic organ prolapse. A prospectively collected, historical control group who underwent the same surgical procedure will be utilized to compare these outcomes when… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Same day discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 1 Jun 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age <80 years old
- Preoperative American Society of Anesthesiologists grade I (normal healthy patient) or II (mild systemic disease)
- Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
- Caretaker at home for at least 24 hours post-operatively
- Able to speak and read English
- Has decision-making capacity and able to provide consent for research participation
Who cannot join
- Laparoscopic, robotic, or open abdominal surgical procedures that require an overnight admission. This may be due to unanticipated additional intraoperative procedures or surgical complications such as unintentional cystotomy or enterotomy, hemorrhage, or anesthetic complication.
- Patients undergoing concomitant laparoscopic colorectal procedures or anal sphincteroplasty
- Surgery start time after 1:00PM, as previous studies have determined this is associated with a decreased likelihood of SDD3,14
- Pregnancy or positive hCG testing, which is standard of care preoperative testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Safety, Cost, and Patient Satisfaction With Same Day Discharge After Minimally-invasive Sacrocolpopexy
This is a prospective cohort study evaluating safety, cost and patient satisfaction with SDD for patients undergoing minimally invasive sacrocolpopexy for pelvic organ prolapse. A prospectively collected, historical control group who underwent the same surgical procedure will be utilized to compare these outcomes when applicable. SDD will be facilitated in part by a utilizing novel patient education video created for this study and implementing an ERAS pathway. All patients meeting eligibility criteria will be approached for study participation. Outcomes will be assessed on POD 0/1 and at the routine post-operative follow up visit, generally at 6 weeks after surgery.
Read the detailed description
Enhanced recovery after surgery (ERAS) pathways play a critical role in the delivery of high-quality surgical care. These protocols incorporate multiple perioperative patient interventions including preemptive analgesia, measures to reduce postoperative nausea and emesis, fluid balance aimed at euvolemia, and both early ambulation and oral intake. ERAS pathways are significant because they have been shown to shorten recovery, decrease hospital stay, reduce complications/nosocomial infections, and conserve resources.1-20 Same-day discharge (SDD) is a central aspect of enhanced recovery pathways.
SDD and ERAS protocols are part of a new initiative within the Women's Health Institute, and their application for gynecologic surgery is of increasing interest across the country.1-19 To date, the focus of studies has largely been on laparoscopic and robotic hysterectomy in the benign and gynecologic oncology literature. Studies have consistently demonstrated both feasibility and safety of SDD after laparoscopic and robotic hysterectomy, with no significant increase in complications or readmissions as compared to discharge on postoperative day (POD) 1. In fact, a recent systematic review by Korsholm et al of 15 observational studies with nearly 12,000 patients revealed SDD is feasible, at a rate of nearly 80%, when patients are properly selected and careful surgical planning is performed.3 Studies have also demonstrated high patient satisfaction10,12 and less cost18 with SDD after minimally invasive hysterectomy. SDD has been applied in other minimally invasive gynecologic procedures, such as minimally invasive myomectomy, with low readmission rates (0.6% within 48 hours, 1.4% over 3 months).20
ERAS pathways can have an important role in other areas of gynecologic surgery. In the field of urogynecology, quality of life reconstructive surgery is often performed to address symptoms of pelvic organ prolapse, urinary incontinence, and/or fecal incontinence. A prospective study by Kalogera et al evaluated the impact of an ERAS pathway for patients undergoing vaginal reconstructive surgeries for pelvic organ prolapse versus historical controls.21 In this cohort, patient satisfaction with perioperative care was high, mean duration of hospital stay was significantly reduced, and there were no differences in 30 day outcomes. In a case series by Zakaria and Levy, an ERAS pathway was utilized after vaginal hysterectomy, which permitted SDD in 96% of patients.19 Notably, only 5 of the 1071 patients required readmission or emergency room evaluation within 30 days of surgery. Taken together, these studies provide support for the application of ERAS pathways in urogynecology, where well-selected surgical candidates are undergoing surgeries appropriate for SDD.
Yet, to date, only one research study has investigated the role of SDD after minimally invasive sacrocolpopexy. A sacrocolpopexy is a surgery for pelvic organ prolapse in which a bridging piece of mesh is utilized to suspend the vaginal cuff to the anterior longitudinal ligament overlying the sacral promontory. This is an extensively studied and highly effective surgical technique to correct pelvic organ prolapse and is a mainstay in the field of urogynecology. A study by Faucheron et al evaluated SDD for robotic and laparoscopic ventral rectopexy, a similar mesh-augmented procedure that is performed for rectal prolapse, and concluded that SDD is feasible and safe.22 A preliminary study by Lloyd et al performed at the Cleveland Clinic within the Female Urology division investigated SDD after minimally invasive sacrocolpopexy (article in press). In this study, SDD was achieved in 10 of 12 patients (83.3%). The two patients who did not have SDD were due to case completion after 6PM, a preset case completion requirement. Outcomes were also retrospectively compared between patients who underwent SDD (N= 10) and patients who stayed overnight (N=30). Only one patient had an emergency department visit on POD 20, due to an unrelated mechanical fall. Importantly, there were no major complications in either group requiring procedural interventions, new prescriptions, or additional interventions. Recently, a study by Kisby et al was published examining SDD after robotic-assisted sacrocolpopexy. In this retrospective study, 80 women underwent SDD compared to 192 who were discharged on >/=POD 1.23 This study found no difference in unplanned provider visits, emergency department visits or readmissions between the groups.
The investigators hypothesize that an ERAS protocol utilizing SDD for minimally invasive sacrocolpopexy is as safe as those that utilize discharge on POD 1 while incurring less total procedure-related costs and being acceptable as a post-op management plan for patients. The objective of this study is to provide data which are necessary to widely implement SDD after a minimally invasive sacrocolpopexy. The results of this research will have a significant impact on increasing patient satisfaction, minimizing resource utilization, and improving clinical practice patterns in the field of urogynecology, both for this procedure and potentially other surgeries within our subspecialty.
Specific Aims Aim 1. To compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
The investigators hypothesize that there is no difference in the incidence of adverse events between SDD compared to discharge on POD 1 after minimally invasive sacrocolpopexy. Using the Epic electronic medical record (EMR), the investigators will evaluate 1) the number of unscheduled office visits, patient-initiated calls for a surgery-related complication, emergency department visits, and readmissions/reoperations of patients who had a SDD protocol and 2) the severity of any adverse events using the Clavien Dindo Scale. The investigators will utilize patient phone calls to inquire about any of the aforementioned events outside of our institution. The investigators will compare incidence of postoperative adverse events between patients undergoing SDD versus a historical control group who were discharged on POD 1.
Aim 2. To compare the total procedure-related costs associated with SDD compared to discharge on POD 1 for minimally invasive sacrocolpopexy.
The investigators hypothesize that the total costs associated with SDD following minimally invasive sacrocolpopexy is less than the same procedure with discharge on POD 1. The investigators will utilize data from the billing function of Epic EMR to compare total procedure-related costs for each approach to minimally invasive sacrocolpopexy.
Aim 3. To determine patient satisfaction with SDD after minimally invasive sacrocolpopexy.
The investigators hypothesize that patients will be satisfied with SDD after minimally invasive sacrocolpopexy. The investigators plan to address this aim using a series of validated measures.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Same day discharge
- 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.
Same day dischargeOther
Patients will be discharged home from the hospital on the day of her surgery.
| Study group | Role | What they receive |
|---|---|---|
| Historical control group | No intervention | The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions |
| Same day discharge group | Experimental | 47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups Receives: Other: Same day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants* With Serious Adverse Events
The investigators wish to compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Measured: 6 weeks postoperatively
Secondary outcomes (3)
Number of Participants With One or More Patient- Initiated Phone Calls
The incidence of patient-initiated phone calls for a surgery-related complication in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Measured: 6 weeks postoperatively
Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials
The incidence of unscheduled office visits, including voiding trials, for patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Measured: 6 weeks postoperatively
Number of Participants With One or More Emergency Department Visits
The incidence of emergency department visits for patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start22 Oct 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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 Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort study with historical controls
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa C Hickman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730103
- Sponsor's protocol ID
- 18-563
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2018
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be made available to other researchers
Publications
Hickman LC, Paraiso MFR, Goldman HB, Propst K, Ferrando CA. Same-Day Discharge After Minimally Invasive Sacrocolpopexy Is Feasible, Safe, and Associated With High Patient Satisfaction. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):e614-e619. doi: 10.1097/SPV.0000000000000998.
PubMed 33411456
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety, Cost, and Patient Satisfaction With Same Day Discharge After Minimally-invasive Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT03730103
- Acronym / sponsor ID
- 18-563
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 25 Sep 2020
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 prospective cohort study evaluating safety, cost and patient satisfaction with SDD for patients undergoing minimally invasive sacrocolpopexy for pelvic organ prolapse. A prospectively collected, historical control group who underwent the same surgical procedure will be utilized to compare these outcomes when applicable. SDD will be facilitated in part by a utilizing novel patient education video created for this study and implementing an ERAS pathway. All patients meeting eligibility criteria will be approached for study participation. Outcomes will be assessed on POD 0/1 and at the routine post-operative follow up visit, generally at 6 weeks after surgery.
Detailed description
Enhanced recovery after surgery (ERAS) pathways play a critical role in the delivery of high-quality surgical care. These protocols incorporate multiple perioperative patient interventions including preemptive analgesia, measures to reduce postoperative nausea and emesis, fluid balance aimed at euvolemia, and both early ambulation and oral intake. ERAS pathways are significant because they have been shown to shorten recovery, decrease hospital stay, reduce complications/nosocomial infections, and conserve resources.1-20 Same-day discharge (SDD) is a central aspect of enhanced recovery pathways.
SDD and ERAS protocols are part of a new initiative within the Women's Health Institute, and their application for gynecologic surgery is of increasing interest across the country.1-19 To date, the focus of studies has largely been on laparoscopic and robotic hysterectomy in the benign and gynecologic oncology literature. Studies have consistently demonstrated both feasibility and safety of SDD after laparoscopic and robotic hysterectomy, with no significant increase in complications or readmissions as compared to discharge on postoperative day (POD) 1. In fact, a recent systematic review by Korsholm et al of 15 observational studies with nearly 12,000 patients revealed SDD is feasible, at a rate of nearly 80%, when patients are properly selected and careful surgical planning is performed.3 Studies have also demonstrated high patient satisfaction10,12 and less cost18 with SDD after minimally invasive hysterectomy. SDD has been applied in other minimally invasive gynecologic procedures, such as minimally invasive myomectomy, with low readmission rates (0.6% within 48 hours, 1.4% over 3 months).20
ERAS pathways can have an important role in other areas of gynecologic surgery. In the field of urogynecology, quality of life reconstructive surgery is often performed to address symptoms of pelvic organ prolapse, urinary incontinence, and/or fecal incontinence. A prospective study by Kalogera et al evaluated the impact of an ERAS pathway for patients undergoing vaginal reconstructive surgeries for pelvic organ prolapse versus historical controls.21 In this cohort, patient satisfaction with perioperative care was high, mean duration of hospital stay was significantly reduced, and there were no differences in 30 day outcomes. In a case series by Zakaria and Levy, an ERAS pathway was utilized after vaginal hysterectomy, which permitted SDD in 96% of patients.19 Notably, only 5 of the 1071 patients required readmission or emergency room evaluation within 30 days of surgery. Taken together, these studies provide support for the application of ERAS pathways in urogynecology, where well-selected surgical candidates are undergoing surgeries appropriate for SDD.
Yet, to date, only one research study has investigated the role of SDD after minimally invasive sacrocolpopexy. A sacrocolpopexy is a surgery for pelvic organ prolapse in which a bridging piece of mesh is utilized to suspend the vaginal cuff to the anterior longitudinal ligament overlying the sacral promontory. This is an extensively studied and highly effective surgical technique to correct pelvic organ prolapse and is a mainstay in the field of urogynecology. A study by Faucheron et al evaluated SDD for robotic and laparoscopic ventral rectopexy, a similar mesh-augmented procedure that is performed for rectal prolapse, and concluded that SDD is feasible and safe.22 A preliminary study by Lloyd et al performed at the Cleveland Clinic within the Female Urology division investigated SDD after minimally invasive sacrocolpopexy (article in press). In this study, SDD was achieved in 10 of 12 patients (83.3%). The two patients who did not have SDD were due to case completion after 6PM, a preset case completion requirement. Outcomes were also retrospectively compared between patients who underwent SDD (N= 10) and patients who stayed overnight (N=30). Only one patient had an emergency department visit on POD 20, due to an unrelated mechanical fall. Importantly, there were no major complications in either group requiring procedural interventions, new prescriptions, or additional interventions. Recently, a study by Kisby et al was published examining SDD after robotic-assisted sacrocolpopexy. In this retrospective study, 80 women underwent SDD compared to 192 who were discharged on >/=POD 1.23 This study found no difference in unplanned provider visits, emergency department visits or readmissions between the groups.
The investigators hypothesize that an ERAS protocol utilizing SDD for minimally invasive sacrocolpopexy is as safe as those that utilize discharge on POD 1 while incurring less total procedure-related costs and being acceptable as a post-op management plan for patients. The objective of this study is to provide data which are necessary to widely implement SDD after a minimally invasive sacrocolpopexy. The results of this research will have a significant impact on increasing patient satisfaction, minimizing resource utilization, and improving clinical practice patterns in the field of urogynecology, both for this procedure and potentially other surgeries within our subspecialty.
Specific Aims Aim 1. To compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
The investigators hypothesize that there is no difference in the incidence of adverse events between SDD compared to discharge on POD 1 after minimally invasive sacrocolpopexy. Using the Epic electronic medical record (EMR), the investigators will evaluate 1) the number of unscheduled office visits, patient-initiated calls for a surgery-related complication, emergency department visits, and readmissions/reoperations of patients who had a SDD protocol and 2) the severity of any adverse events using the Clavien Dindo Scale. The investigators will utilize patient phone calls to inquire about any of the aforementioned events outside of our institution. The investigators will compare incidence of postoperative adverse events between patients undergoing SDD versus a historical control group who were discharged on POD 1.
Aim 2. To compare the total procedure-related costs associated with SDD compared to discharge on POD 1 for minimally invasive sacrocolpopexy.
The investigators hypothesize that the total costs associated with SDD following minimally invasive sacrocolpopexy is less than the same procedure with discharge on POD 1. The investigators will utilize data from the billing function of Epic EMR to compare total procedure-related costs for each approach to minimally invasive sacrocolpopexy.
Aim 3. To determine patient satisfaction with SDD after minimally invasive sacrocolpopexy.
The investigators hypothesize that patients will be satisfied with SDD after minimally invasive sacrocolpopexy. The investigators plan to address this aim using a series of validated measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort study with historical controls
| Arm | Type | Receives |
|---|---|---|
| Historical control group | No intervention | –The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions |
| Same day discharge group | Experimental | Other: Same day discharge47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age <80 years old
- Preoperative American Society of Anesthesiologists grade I (normal healthy patient) or II (mild systemic disease)
- Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
- Caretaker at home for at least 24 hours post-operatively
- Able to speak and read English
Key exclusion criteria (4 listed)
- Laparoscopic, robotic, or open abdominal surgical procedures that require an overnight admission. This may be due to unanticipated additional intraoperative procedures or surgical complications such as unintentional cystotomy or enterotomy, hemorrhage, or anesthetic complication.
- Patients undergoing concomitant laparoscopic colorectal procedures or anal sphincteroplasty
- Surgery start time after 1:00PM, as previous studies have determined this is associated with a decreased likelihood of SDD3,14
- Pregnancy or positive hCG testing, which is standard of care preoperative testing
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 |
|---|---|---|
| Same day dischargePatients will be discharged home from the hospital on the day of her surgery. | Other | Same day discharge group |
Primary outcome
Number of Participants* With Serious Adverse Events
Time frame: 6 weeks postoperatively
The investigators wish to compare the incidence of adverse events in patients following a SDD protocol for minimally invasive sacrocolpopexy compared to those patients discharged on POD 1.
3 secondary outcomes
Number of Participants With One or More Patient- Initiated Phone Calls
Time frame: 6 weeks postoperatively
Number of Participants With One or More Unscheduled Office Visits, Including Voiding Trials
Time frame: 6 weeks postoperatively
Number of Participants With One or More Emergency Department Visits
Time frame: 30 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33411456Hickman LC, Paraiso MFR, Goldman HB, Propst K, Ferrando CA. Same-Day Discharge After Minimally Invasive Sacrocolpopexy Is Feasible, Safe, and Associated With High Patient Satisfaction. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):e614-e619. doi: 10.1097/SPV.0000000000000998.
- Individual participant dataSharing planned: No. Individual patient data will not be made available to other researchers
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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.
Lisa C Hickman, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day discharge in people with Pelvic Organ Prolapse, run by The Cleveland Clinic 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 6 inclusion and 4 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2020). 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?
Number of Participants* With Serious Adverse Events (time frame: 6 weeks 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 NCT03730103, 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 25 Sep 2020.