Same-day Discharge After Reconstructive Pelvic Surgery

NCT ID: NCT04129541

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Reconstructive Pelvic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Same Day Discharge

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Overnight Hospitalization

Intervention Type OTHER

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

Interventions

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Same Day Discharge

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oz Harmanli, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Yale Urogynecology and Pelvic Reconstructive Surgery

Other Identifiers

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2000026647

Identifier Type: -

Identifier Source: org_study_id

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