Same-day Discharge After Reconstructive Pelvic Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Reconstructive Pelvic Surgery
• Intervention / Treatment: Other: Same Day Discharge; Other: 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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SDD; 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.	Other: Same Day Discharge; Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria.
Active Comparator: OH; 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.	Other: Overnight Hospitalization; Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 to 8 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	6 to 8 weeks after surgery

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Oz Harmanli, MD, Chief, Yale Urogynecology and Pelvic Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2000026647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No