Clinical trial NCT03627234: Same Day Discharge vs. Overnight Stay After Hysterectomy
Official title: Same Day Discharge vs. Overnight Stay After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Satisfaction
Safety Issues
Quality of Life
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction as measured by the Surgical Satisfaction Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Health Related Quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
Study officials:
References: