Web-based Versus Standard Information for Same Day Hysterectomy (WISH) (WISH)
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ClinicalTrials.gov Identifier: NCT06011538 |
Recruitment Status :
Not yet recruiting
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
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Objectives: To evaluate the potential utility and efficacy of additional on-line, patient education resource for same day discharge following laparoscopic hysterectomy (SDD LH) compared to standard information resources alone
Trial Design: A pilot, parallel, open, single centre, randomised controlled trial
Participant Population and Sample Size: 40 women undergoing SDD LH for a benign reason
Eligibility Criteria: Women with gynaecological conditions requiring a laparoscopic hysterectomy (LH) and who are suitable for same day discharge (SDD).
Interventions: An online patient education website resource and the comparator is standard practice for provision of patient information (written and verbal).
Outcome Measures:
Primary
- Compliance with SDD Secondary
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In Hospital:
o Surgical details / complexity / intraoperative and post-operative serious adverse events (SAEs) according to the Clavien-Dindo system grade II-IV which is a widely used index for the classification of surgical complications [case notes and electronic patient record], and time to discharge
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6 weeks:
- Satisfaction, acceptability and utility of patient education / information provided (bespoke patient questionnaire; Likert scales)
- Satisfaction with care after LH (6-point Likert)
- Generic quality of life at 6 weeks post-surgery (EuroQol-5D-5L and VAS);
- Contact with Community & Clinical Care Services i.e. outpatients or emergency visits, re-presentations / re-admissions to hospital (Case report form [CRF], case notes, electronic patient record)
- Serious Adverse Events (CRF, case notes, electronic patient record)
- Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (Modified items / response categories)
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12 weeks:
- Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (Modified items / response categories) Time to return to work (if working)
Condition or disease | Intervention/treatment | Phase |
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Hysterectomy LAP | Other: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy | Not Applicable |
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Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | To evaluate the potential efficacy of additional on-line, patient education for SDD LH in achieving SDD compared to standard information giving. In addition, the utility and acceptability of patient information will be assessed as well as the impact on patient satisfaction and recovery. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | The WISH Trial (Web-based Versus Standard Information for Same Day Hysterectomy) |
Estimated Study Start Date : | September 2023 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | March 2024 |
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Arm | Intervention/treatment |
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Experimental: On-line SDD LH website resource (intervention)
Patients allocated the experimental arm will be provided with the link to the SDD LH patient information website (https://www.mydaycasehysterectomy.com).The option of this educational material will be in addition to the standard verbal and written patient information provided by the BWCH.
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Other: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy
A patient educational website that provides clear, easily accessible, patient friendly information explaining what SDD after laparoscopic hysterectomy is, why SDD may be beneficial and what to expect from decision for surgery, through to the admission to hospital and immediate, short and long term recovery. |
Active Comparator: Standard practice for information provision (control)
Patients allocated the control group will receive standard BWCH information only.
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Other: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy
A patient educational website that provides clear, easily accessible, patient friendly information explaining what SDD after laparoscopic hysterectomy is, why SDD may be beneficial and what to expect from decision for surgery, through to the admission to hospital and immediate, short and long term recovery. |
- Same Day Discharge following laparoscopic hysterectomy (0-23hours) [ Time Frame: 0-24hours following surgery ]This means that the patient is discharged (leaves the hospital) before midnight on the day of surgery (case notes / electronic patient record).
- Satisfaction with care on discharge (bespoke patient questionnaire score) [ Time Frame: 0-24hours following surgery ]Patient satisfaction of same day discharge following laparoscopic hysterectomy (LH). protocol. This will be assessed through bespoke patient questionnaire.
- Acceptability and utility of patient education / information provided (score) [ Time Frame: 6 weeks ]Patient satisfaction of acceptability and utility of patient education / information provided. This will be assessed through bespoke patient questionnaire.
- Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score) [ Time Frame: 6 weeks ]Patient's satisfaction with clinical outcome after laparoscopic hysterectomy (LH) through(5-point Likert)
- Satisfaction with care on discharge (score) [ Time Frame: 6 weeks ]Patient's satisfaction with care on discharge through bespoke patient questionnaire
- Generic quality of life post-surgery (score) [ Time Frame: 6 weeks ]Patient's Quality of life score using EuroQol-5D-5L questionnaire
- Generic quality of life post-surgery (score) [ Time Frame: 6 weeks ]Patient's Quality of life score using EuroQol-5D-5L visual analogue scale
- Contact with Community & Clinical Care Services [ Time Frame: 6 weeks ]Serious Adverse Events through case report forms (CRF)
- Time from surgery to resumption of usual activities in days [ Time Frame: 6-12 weeks ]Time from surgery to resumption of usual activities using the PROMIS-SF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire (item bank v1.2 will be used). Of the 29 items covering relevant activities for our study population, we have selected 8 items and. The selected items and the response categories were chosen by the PPI focus group to reflect the most common and generally applicable day-to-day activities. Participants will record when each activity is resumed, with full recovery being achieved once all 8 personalised activities have been resumed.
- Time to return to work (if working) in days [ Time Frame: 6-12 weeks ]This will be assessed using bespoke patient questionnaire
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Able to give informed consent to participate
- Have a benign gynaecological condition that is being treated with a LH
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Eligible to be on same day discharge pathway Patient factors
- ASA I/II with no sleep apnoea. ASA III may be suitable if comorbidities are stable and optimised.
- No known cardio-pulmonary compromise
- No known renal disease
- Age </= 60 years
- BMI </=40
- Not indication for admission to Gynaecological Extended Recovery Area (GERU)
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Surgical factors
- Presumed benign disease
- No anticipated surgical complications
- Concomitant procedures acceptable but surgeon to decide on a case by case basis Discharge factors
- Residence < 1 hour from BWCH
- Access to transport from hospital to home
Exclusion Criteria:
- Patient above the age of 60
- Unwillingness or inability to comply with protocol procedures
- Women who require concomitant gynaecological surgery for bladder or other pelvic support
- Women who require concomitant gynaecological surgery for excision of deep endometriosis that requires dissection of the pararectal space above the age of 60
- Unwillingness or inability to comply with protocol procedures
- Women who require concomitant gynaecological surgery for bladder or other pelvic support
- Women who require concomitant gynaecological surgery for excision of deep endometriosis that requires dissection of the pararectal space
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011538
Contact: Lina Antoun, MD, MRCOG | 044 7518613461 | lina.antoun1@nhs.net | |
Contact: Paul Smith, MD, MRCOG | paul.smith54@nhs.net |
Principal Investigator: | TJustin Clark, MD, FRCOG | Birmingham Women's and Children's NHS Foundation Trust |
Publications of Results:
Other Publications:
Responsible Party: | Birmingham Women's and Children's NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT06011538 |
Other Study ID Numbers: |
BirminghamWCNHSFT |
First Posted: | August 25, 2023 Key Record Dates |
Last Update Posted: | August 25, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | IPD will only be shared as part of results in a peer reviewed publication. No specific or individual participant data will be shared |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Same day discharge Laparoscopic hysterectomy Educational platform Enhanced recovery |