NCT03627234

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

July 30, 2018

Last Update Submit

October 10, 2022

Conditions

SatisfactionSafety IssuesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction as measured by the Surgical Satisfaction Scale

    Patient satisfaction with Same day discharge vs overnight stay. This will be measured using the Surgical Satisfaction Questionnaire The SSQ is an 8-item questionnaire, with responses recorded on a 5-point Likert type scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." The mean average of the 8 scores is being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction. Items 1 and 2 are used to calculate the Pain subscale; items 3, 4, and 5 are used for the Return to baseline subscale: and items 6, 7, and 8 are used for the Global satisfaction subscale. The questionnaire will be administered after surgery (day 10-14 postoperatively) at their postoperative visit at the clinic.

    2 weeks

Secondary Outcomes (1)

  • Health Related Quality of life

    6 weeks

Study Arms (2)

Same Day Discharge

EXPERIMENTAL

Same day discharge after hysterectomy is the standard of care at George Washington University Hospital.

Behavioral: Same Day Discharge

Overnight stay

EXPERIMENTAL

Overnight stay is not the standard of care at George Washington University Hospital. It is being used as an experimental condition.

Behavioral: Overnight Stay

Interventions

Same Day DischargeBEHAVIORAL

Patients will be randomized to same day discharge

Same Day Discharge
Overnight StayBEHAVIORAL

Patients will be randomized to stay overnight

Overnight stay

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCis-gender females
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myomectomy or hysterectomy planned for a benign gynecologic reason. (This means that there is no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.)
  • Patient is scheduled to have surgery with one of the minimally invasive gynecologic surgeons at GWUH. (Dr. Moawad, Dr. Marfori, Dr. Abi Khalil or Dr. Vargas)
  • Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH), a total laparoscopic hysterectomy (TLH), a robotic assisted laparoscopic myomectomy (RA-myomectomy) or a laparoscopic myomectomy.
  • Patient is capable of informed consent.
  • Patient is capable of completing the questionnaires.
  • Patient must be between 18 and 65 years of age.

You may not qualify if:

  • Myomectomy or hysterectomy is indicated for malignancy.
  • Procedure is anything other than RA-TLH, TLH, RA-myomectomy or a laparoscopic myomectomy.
  • Surgeon is not one of the minimally invasive surgeons at GWUH.
  • Surgery is scheduled for a hospital other than GWUH.
  • Patient is less than 18 years of age or greater than 65.
  • Patient is not capable of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 13, 2018

Study Start

July 10, 2018

Primary Completion

December 31, 2020

Study Completion

September 8, 2021

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

US(1)