Clinical trial NCT04129541: Same-day Discharge After Reconstructive Pelvic Surgery
Official title: Same-day Discharge After Reconstructive Pelvic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Reconstructive Pelvic Surgery
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for pelvic organ prolapse, with or without concomitant hysterectomy or incontinence procedure.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Quality of Recovery Score
timeFrame: 6 to 8 weeks after surgery
measure: Patient Satisfaction
timeFrame: 6 to 8 weeks after surgery
Secondary outcomes:
measure: Safety Measures: frequency of post operative complications
timeFrame: Up to 8 weeks after surgery
measure: Quality of Recovery (baseline)
timeFrame: Baseline
measure: Quality of Recovery (48 hours)
timeFrame: 48 hours postop
measure: Quality of Recovery (at postop visit)
timeFrame: 48 hours postop
measure: Pelvic Floor Distress (baseline)
timeFrame: Baseline
measure: Pelvic Floor Distress (postop)
timeFrame: 6 to 8 weeks after surgery
measure: Pelvic Floor Impact (baseline)
timeFrame: Baseline
measure: Pelvic Floor Impact (postop)
timeFrame: 6 to 8 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Chief, Yale Urogynecology and Pelvic Reconstructive Surgery
name: Oz Harmanli, MD
role: PRINCIPAL_INVESTIGATOR
References: