Same Day Discharge vs. Overnight Stay After Hysterectomy



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:8/15/2018
Start Date:July 10, 2018
End Date:January 31, 2021
Contact:Alexandra North, BS
Email:anorth@mfa.gwu.edu
Phone:2027412592

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Same Day Discharge vs. Overnight Stay After Minimally Invasive Hysterectomy: A Randomized Controlled Trial

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.

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
1
site
Washington, District of Columbia 20037
Principal Investigator: Gaby Moawad, MD
Phone: 202-741-2592
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from
Washington,
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