Same-day Discharge After Reconstructive Pelvic Surgery

Yale University

Status: Withdrawn

Conditions: Reconstructive Pelvic Surgery

Treatments: Other: Same Day Discharge; Other: Overnight Hospitalization

Study type: Interventional

Funder types: Other

Identifiers

NCT04129541

2000026647

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

SDD

Active Comparator group

Description:

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.

Treatment:

Other: Same Day Discharge

OH

Active Comparator group

Description:

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.

Treatment:

Other: Overnight Hospitalization