Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-12 @ 5:27 PM
Study NCT ID:
NCT03627234
Status:
WITHDRAWN
Last Update Posted:
2022-10-13
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Same Day Discharge vs. Overnight Stay After Hysterectomy
Sponsor:
George Washington University
Organization:
Study Overview
Official Title:
Same Day Discharge vs. Overnight Stay After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SDD
Brief Summary:
In this study patients are randomized between same-day discharge and overnight stay after undergoing a minimally invasive hysterectomy or myomectomy. The goal is to both compare patients' satisfaction and safety and quality of life (QOL) as well as financial consequences between the two groups.
The investigators hope to demonstrate that same-day discharge is safe and feasible for most patients with the same level of satisfaction and safety and QOL compared to overnight stay. And also the investigators seek to determine which demographic, medical, social and intra-operative factors influence duration of admission, satisfaction, safety and QOL.
The investigators hope to demonstrate that same-day discharge is safe and feasible for most patients with the same level of satisfaction and safety and QOL compared to overnight stay. And also the investigators seek to determine which demographic, medical, social and intra-operative factors influence duration of admission, satisfaction, safety and QOL.
Detailed Description:
1. Subject recruitment and consent: Subject recruitment will take place in the GW MFA outpatient clinic for the MIGS surgeons among patients desiring a myomectomy or a hysterectomy for a benign gynecologic reason (heavy bleeding, fibroids, pelvic pain) without comorbidities that require overnight stay (as decided by their provider). Interested subjects will be counseled and consented by a member of the research team. If the subjects choose to participate the consent form will be signed at that time or if the subjects need more time to consider participation the consent form will be signed at the pre-operative visit.
2. At the pre-operative visit, computer-generated randomization will be used to assign patients to
A) Discharge the day of surgery (before midnight on the day of surgery) OR B) Discharge after an overnight stay.
Patients will be informed about their assigned group during this visit to be able to prepare their discharge and recovery period with care-takers at home. Participants will complete the health-related quality of life (HrQoL) questionnaire EQ-5D before surgery as a baseline measurement and complete a survey including basic demographic information (detailed prior).
3. Study participants will then undergo a minimally invasive hysterectomy or myomectomy by one of the highly experienced minimally invasive gynecologists using a standard technique. Their approaches to hysterectomy and myomectomy are similar and according to the normal standard of care.
4. In case of protocol deviation by participants,the investigators will record why the participants decided to deviate from the protocol to be able to identify factors that influence length of hospital stay. The investigators will conduct an intention-to-treat analysis to correct for these protocol deviations. The investigators will counsel patients thoroughly to try to minimize the number of protocol deviations.
5. Hospital (operative and pathology reports) and clinical (clinical visit notes) reports will be reviewed to compare baseline demographics, preoperative hemoglobin, past surgical history, past medical history, comorbidities, operative time, case end time, estimated blood loss, uterine weight and complications between the same-day discharge and overnight stay group.
6. Patients will complete the HrQoL questionnaire on days 0, 1, 2, 4 and 7 using the self- completed EQ-5D.
7. Hospital and ED notes will be checked for unexpected postoperative visits, re-evaluations and re-admissions.
8. At their postoperative visit 2 weeks after their surgery patients will be asked to complete the surgical satisfaction questionnaire (SSQ-8) and to score feelings of safety regarding the timing of their discharge on a scale from 0-10
2. At the pre-operative visit, computer-generated randomization will be used to assign patients to
A) Discharge the day of surgery (before midnight on the day of surgery) OR B) Discharge after an overnight stay.
Patients will be informed about their assigned group during this visit to be able to prepare their discharge and recovery period with care-takers at home. Participants will complete the health-related quality of life (HrQoL) questionnaire EQ-5D before surgery as a baseline measurement and complete a survey including basic demographic information (detailed prior).
3. Study participants will then undergo a minimally invasive hysterectomy or myomectomy by one of the highly experienced minimally invasive gynecologists using a standard technique. Their approaches to hysterectomy and myomectomy are similar and according to the normal standard of care.
4. In case of protocol deviation by participants,the investigators will record why the participants decided to deviate from the protocol to be able to identify factors that influence length of hospital stay. The investigators will conduct an intention-to-treat analysis to correct for these protocol deviations. The investigators will counsel patients thoroughly to try to minimize the number of protocol deviations.
5. Hospital (operative and pathology reports) and clinical (clinical visit notes) reports will be reviewed to compare baseline demographics, preoperative hemoglobin, past surgical history, past medical history, comorbidities, operative time, case end time, estimated blood loss, uterine weight and complications between the same-day discharge and overnight stay group.
6. Patients will complete the HrQoL questionnaire on days 0, 1, 2, 4 and 7 using the self- completed EQ-5D.
7. Hospital and ED notes will be checked for unexpected postoperative visits, re-evaluations and re-admissions.
8. At their postoperative visit 2 weeks after their surgery patients will be asked to complete the surgical satisfaction questionnaire (SSQ-8) and to score feelings of safety regarding the timing of their discharge on a scale from 0-10
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: