SatisfactionSDDNCT03627234
Same Day Discharge vs. Overnight Stay After Hysterectomy
A study testing Same Day Discharge and Overnight Stay in people with Satisfaction and Safety Issues, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Safety Issues, Quality of Life
- What is being tested?
- Same Day Discharge and Overnight Stay
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the detailed description
- 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.
- At the pre-operative visit, computer-generated randomization will be used to assign patients to
- 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).
- 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.
- 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.
- 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.
- Patients will complete the HrQoL questionnaire on days 0, 1, 2, 4 and 7 using the self- completed EQ-5D.
- Hospital and ED notes will be checked for unexpected postoperative visits, re-evaluations and re-admissions.
- 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
- Conditions
- Satisfaction, Safety Issues, Quality of Life
- Being tested
- Same Day Discharge, Overnight Stay
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day DischargeBehavioural
Patients will be randomized to same day discharge
Overnight StayBehavioural
Patients will be randomized to stay overnight
| Study group | Role | What they receive |
|---|---|---|
| Same Day Discharge | Experimental | Same day discharge after hysterectomy is the standard of care at George Washington University Hospital. Receives: 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. Receives: Behavioral: Overnight Stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
Health Related Quality of life
The quality of life that patients report using the Health related quality of life EuroQuol group, the Netherlands. The EQ-5D has 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument has been shown to be valid and reliable for use in a wide range of health conditions and can be administered daily
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start10 Jul 2018
- Primary completion31 Dec 2020
- Study completion8 Sep 2021
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627234
- Sponsor's protocol ID
- 041832
- Acronym
- SDD
- Status last verified
- Oct 2022
- First submitted
- 30 Jul 2018
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Discharge vs. Overnight Stay After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03627234
- Acronym / sponsor ID
- SDD / 041832
- Conditions
- Satisfaction, Safety Issues, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- At the pre-operative visit, computer-generated randomization will be used to assign patients to
- 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).
- 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.
- 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.
- 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.
- Patients will complete the HrQoL questionnaire on days 0, 1, 2, 4 and 7 using the self- completed EQ-5D.
- Hospital and ED notes will be checked for unexpected postoperative visits, re-evaluations and re-admissions.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same Day Discharge | Experimental | Behavioral: Same Day DischargeSame day discharge after hysterectomy is the standard of care at George Washington University Hospital. |
| Overnight stay | Experimental | Behavioral: Overnight StayOvernight stay is not the standard of care at George Washington University Hospital. It is being used as an experimental condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same Day DischargePatients will be randomized to same day discharge | Behavioural | Same Day Discharge |
| Overnight StayPatients will be randomized to stay overnight | Behavioural | Overnight stay |
Primary outcome
Patient Satisfaction as measured by the Surgical Satisfaction Scale
Time frame: 2 weeks
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.
1 secondary outcome
Health Related Quality of life
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same Day Discharge and Overnight Stay in people with Satisfaction and Safety Issues, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction as measured by the Surgical Satisfaction Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.