Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
George Washington University
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
Age
18–65
Sex
FEMALE
Healthy volunteers
Accepted
