Same-day Discharge After Reconstructive Pelvic Surgery

Not Applicable

Withdrawn

• Conditions: Reconstructive Pelvic Surgery
• Interventions: Other: Overnight Hospitalization; Other: Same Day Discharge

• Registration Number: NCT04129541
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Study Start: 2020-07-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26
• Primary Completion: 2022-10-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OH	Overnight Hospitalization	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.
SDD	Same Day Discharge	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.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Recovery Score	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	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.

Secondary Outcome Measures

Name	Time	Method
Safety Measures: frequency of post operative complications	Up to 8 weeks after surgery	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.
Pelvic Floor Distress (postop)	6 to 8 weeks after surgery	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.
Quality of Recovery (baseline)	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.
Quality of Recovery (48 hours)	48 hours postop	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.
Pelvic Floor Distress (baseline)	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.
Pelvic Floor Impact (baseline)	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.
Quality of Recovery (at postop visit)	48 hours postop	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.
Pelvic Floor Impact (postop)	6 to 8 weeks after surgery	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.