Reconstructive Pelvic SurgeryNCT04129541
Same-day Discharge After Reconstructive Pelvic Surgery
A study testing Same Day Discharge and Overnight Hospitalization in people with Reconstructive Pelvic Surgery, run by Yale University.
Trial summary
The purpose of this study is to determine the safety and acceptability of same-day discharge after surgery for pelvic floor disorders. The study hypotheses are that same-day discharge after reconstructive pelvic surgery is safe and improves patient satisfaction when compared to overnight hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Reconstructive Pelvic Surgery
- What is being tested?
- Same Day Discharge and Overnight Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery for pelvic organ prolapse, with or without concomitant hysterectomy or incontinence procedure.
Who cannot join
- Patients undergoing concomitant non-gynecologic procedure
- The presence of: gynecologic malignancy, American Society of Anesthesiologists (ASA) class >2, severe cardiovascular or pulmonary comorbidities, prior anesthesia complication, or obstructive sleep apnea
- Anyone living alone with no family/friend/caretaker to assist the patient on day of surgery
About this study
The purpose of this study is to determine the safety and acceptability of same-day discharge after surgery for pelvic floor disorders. The study hypotheses are that same-day discharge after reconstructive pelvic surgery is safe and improves patient satisfaction when compared to overnight hospitalization.
Read the detailed description
This study is a randomized clinical trial comparing same day discharge and overnight hospitalization after reconstructive pelvic surgery. Patients who are scheduled to undergo surgery for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) will be recruited at their preoperative visit. Patients will be counseled regarding the existing evidence demonstrating the safety of same day discharge after hysterectomy and pelvic floor reconstructive surgery. Eligible patients who provide consent will be randomized to same day discharge or overnight hospitalization following surgery.
Patients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the Post-Anesthesia Care Unit (PACU) for all patients. Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. If the patients require unplanned hospitalization (UH), the reason for hospitalization will be noted. Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.
At their postoperative office visit, all patients will complete surveys evaluating patient satisfaction. Demographic, surgical, and hospital admission data will be collected from the medical record. Information will also be collected regarding any complications, emergency department (ED) visits, unplanned office visits, readmissions, and reoperations within 8 weeks after surgery.
- Conditions
- Reconstructive Pelvic Surgery
- Being tested
- Same Day Discharge, Overnight Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day DischargeOther
Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria.
Overnight HospitalizationOther
Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.
| Study group | Role | What they receive |
|---|---|---|
| SDD | Active comparator | Patients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the PACU for all patients. Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. Receives: Other: Same Day Discharge |
| OH | Active comparator | Patients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the PACU for all patients. Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria. Receives: Other: Overnight Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Recovery Score
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) at baseline, 48 hours postop, and 6-8 weeks postop. The QoR-15 consists of 15 questions scored on a 0 to 10 scale, maximum score 150. Higher scores indicate good recovery after surgery while lower scores indicate poor recovery.
Measured: 6 to 8 weeks after surgery
Patient Satisfaction
Patient satisfaction will be assessed using the Patient Global Impression of Improvement (PGI-I) at 6-8 weeks postop. The PGI-I consists of 1 question scored 1-7, with lower number indicating better global improvement.
Measured: 6 to 8 weeks after surgery
Secondary outcomes (8)
Safety Measures: frequency of post operative complications
Safety will be measured by the frequency of post operative complications, this will include counts of emergency department visits, readmissions, and reoperations; as well as frequency of any unplanned office visits and phone calls within 8 weeks after surgery.
Measured: Up to 8 weeks after surgery
Quality of Recovery (baseline)
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) at baseline, 48 hours postop, and 6-8 weeks postop. The QoR-15 consists of 15 questions scored on a 0 to 10 scale, maximum score 150. Higher scores indicate good recovery after surgery while lower scores indicate poor recovery.
Measured: Baseline
Quality of Recovery (48 hours)
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) at baseline, 48 hours postop, and 6-8 weeks postop. The QoR-15 consists of 15 questions scored on a 0 to 10 scale, maximum score 150. Higher scores indicate good recovery after surgery while lower scores indicate poor recovery.
Measured: 48 hours postop
Quality of Recovery (at postop visit)
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) at baseline, 48 hours postop, and 6-8 weeks postop. The QoR-15 consists of 15 questions scored on a 0 to 10 scale, maximum score 150. Higher scores indicate good recovery after surgery while lower scores indicate poor recovery.
Measured: 48 hours postop
Pelvic Floor Distress (baseline)
Pelvic floor distress will be assessed using the Pelvic Floor Distress Inventory (PFDI-20) summary score at baseline and 6-8 weeks postop. The PFDI-20 consists of 20 questions scored on a 0 to 4 scale, divided into three scales consisting of 6, 8, and 6 questions each. For scoring, the mean value is obtained for each scale (0-4) and multiplied by 25 to obtain the scale score (0-100). The summary PFDI score is the sum of the three scale scores (0-300). Higher score indicates higher distress from pelvic floor disorder symptoms.
Measured: Baseline
Pelvic Floor Distress (postop)
Pelvic floor distress will be assessed using the Pelvic Floor Distress Inventory (PFDI-20) summary score at baseline and 6-8 weeks postop. The PFDI-20 consists of 20 questions scored on a 0 to 4 scale, divided into three scales consisting of 6, 8, and 6 questions each. For scoring, the mean value is obtained for each scale (0-4) and multiplied by 25 to obtain the scale score (0-100). The summary PFDI score is the sum of the three scale scores (0-300). Higher score indicates higher distress from pelvic floor disorder symptoms.
Measured: 6 to 8 weeks after surgery
Pelvic Floor Impact (baseline)
Pelvic floor impact will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ-7) at baseline and 6-8 weeks postop. The PFIQ-7 consists of 21 questions scored on a 0 to 3 scale, divided into three scales consisting of 7 questions each. For scoring, the mean value is obtained for each scale (0-3) and multiplied by 100/3 to obtain the scale score (0-100). The summary PFIQ score is the sum of the three scale scores (0-300). Higher score indicates higher impact of pelvic floor disorders on activities, relationships, and feelings.
Measured: Baseline
Pelvic Floor Impact (postop)
Pelvic floor impact will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ-7) at baseline and 6-8 weeks postop. The PFIQ-7 consists of 21 questions scored on a 0 to 3 scale, divided into three scales consisting of 7 questions each. For scoring, the mean value is obtained for each scale (0-3) and multiplied by 100/3 to obtain the scale score (0-100). The summary PFIQ score is the sum of the three scale scores (0-300). Higher score indicates higher impact of pelvic floor disorders on activities, relationships, and feelings.
Measured: 6 to 8 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 posted17 Oct 2019
- Study start1 Jul 2020 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Pelvic SurgeryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oz Harmanli, MD, Principal investigator, Chief, Yale Urogynecology and Pelvic Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129541
- Sponsor's protocol ID
- 2000026647
- Status last verified
- Apr 2021
- First submitted
- 10 Oct 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-day Discharge After Reconstructive Pelvic Surgery
- ClinicalTrials.gov ID
- NCT04129541
- Acronym / sponsor ID
- 2000026647
- Conditions
- Reconstructive Pelvic Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and acceptability of same-day discharge after surgery for pelvic floor disorders. The study hypotheses are that same-day discharge after reconstructive pelvic surgery is safe and improves patient satisfaction when compared to overnight hospitalization.
Detailed description
This study is a randomized clinical trial comparing same day discharge and overnight hospitalization after reconstructive pelvic surgery. Patients who are scheduled to undergo surgery for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) will be recruited at their preoperative visit. Patients will be counseled regarding the existing evidence demonstrating the safety of same day discharge after hysterectomy and pelvic floor reconstructive surgery. Eligible patients who provide consent will be randomized to same day discharge or overnight hospitalization following surgery.
Patients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the Post-Anesthesia Care Unit (PACU) for all patients. Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. If the patients require unplanned hospitalization (UH), the reason for hospitalization will be noted. Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.
At their postoperative office visit, all patients will complete surveys evaluating patient satisfaction. Demographic, surgical, and hospital admission data will be collected from the medical record. Information will also be collected regarding any complications, emergency department (ED) visits, unplanned office visits, readmissions, and reoperations within 8 weeks after surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDD | Active comparator | Other: Same Day DischargePatients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the PACU for all patients. Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. |
| OH | Active comparator | Other: Overnight HospitalizationPatients will receive routine care during their admission for surgery. A standard voiding trial will be performed in the PACU for all patients. Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgery for pelvic organ prolapse, with or without concomitant hysterectomy or incontinence procedure.
Key exclusion criteria (3 listed)
- Patients undergoing concomitant non-gynecologic procedure
- The presence of: gynecologic malignancy, American Society of Anesthesiologists (ASA) class >2, severe cardiovascular or pulmonary comorbidities, prior anesthesia complication, or obstructive sleep apnea
- Anyone living alone with no family/friend/caretaker to assist the patient on day of surgery
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 in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria. | Other | SDD |
| Overnight HospitalizationPatients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria. | Other | OH |
Primary outcome
Change in Quality of Recovery Score
Time frame: 6 to 8 weeks after surgery
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) at baseline, 48 hours postop, and 6-8 weeks postop. The QoR-15 consists of 15 questions scored on a 0 to 10 scale, maximum score 150. Higher scores indicate good recovery after surgery while lower scores indicate poor recovery.
Patient Satisfaction
Time frame: 6 to 8 weeks after surgery
Patient satisfaction will be assessed using the Patient Global Impression of Improvement (PGI-I) at 6-8 weeks postop. The PGI-I consists of 1 question scored 1-7, with lower number indicating better global improvement.
8 secondary outcomes
Safety Measures: frequency of post operative complications
Time frame: Up to 8 weeks after surgery
Quality of Recovery (baseline)
Time frame: Baseline
Quality of Recovery (48 hours)
Time frame: 48 hours postop
Quality of Recovery (at postop visit)
Time frame: 48 hours postop
Pelvic Floor Distress (baseline)
Time frame: Baseline
Pelvic Floor Distress (postop)
Time frame: 6 to 8 weeks after surgery
Pelvic Floor Impact (baseline)
Time frame: Baseline
Pelvic Floor Impact (postop)
Time frame: 6 to 8 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- 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.
Oz Harmanli, MD principal investigator
Chief, Yale Urogynecology and Pelvic Reconstructive Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Same Day Discharge and Overnight Hospitalization in people with Reconstructive Pelvic Surgery, run by Yale University.
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 1 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: withdrawn, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in Quality of Recovery Score (time frame: 6 to 8 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.