Same-day Discharge After Reconstructive Pelvic Surgery

NCT04129541 | Withdrawn DMC

• 1 other identifier: 2000026647
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reconstructive Pelvic Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Safety Measures: frequency of post operative complications

  Up to 8 weeks after surgery

• Quality of Recovery (baseline)

  Baseline

• Quality of Recovery (48 hours)

  48 hours postop

• Quality of Recovery (at postop visit)

  48 hours postop

• Pelvic Floor Distress (baseline)

  Baseline

Study Arms (2)

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.

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.

Other: Overnight Hospitalization

Interventions

Same Day Discharge OTHER

Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria.

SDD

Overnight Hospitalization OTHER

Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.

OH

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Officials

• Oz Harmanli, MD

  Chief, Yale Urogynecology and Pelvic Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 17, 2019
• Study Start: July 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: April 30, 2023
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share