Web-based Versus Standard Information for Same Day Hysterectomy (WISH)

Hysterectomy Clinical Trial

— WISH  

Official title:

The WISH Trial (Web-based Versus Standard Information for Same Day Hysterectomy)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06011538
• Other study ID #: BirminghamWCNHSFT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: Birmingham Women's and Children's NHS Foundation Trust
• Contact: Lina Antoun, MD, MRCOG
• Phone: 044 7518613461
• Email: lina.antoun1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

• 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

• 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)

• 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)

Description:

Aim:

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.

Objectives:

The investigators aim to assess various aspects of trial management and design. In order to achieve this, the objectives of the pilot randomised controlled trial (RCT) will be split into:

• Process Objectives

• To determine the proportion of eligible women that are screened and meet the inclusion criteria

• To determine the proportion of eligible women that agree to be randomised

• To determine the robustness of proposed data collection tools; completion and return rates

• Clinical Objectives

• To determine the appropriateness of the outcome measures

• To derive clinical data to help inform the sample size for a future substantive study (the potential efficacy of additional on-line, patient education for SDD LH in achieving SDD compared to standard information giving).

Trial design and setting

Trial design:

A pilot, parallel, open, single centre, randomised controlled trial.

Trial Setting:

Recruitment to the Web-based Versus Standard Information for Same Day Hysterectomy (WISH) study will take place in gynaecology departments (general and relevant specialist clinics including menstrual disorders and pelvic pain clinics, hysteroscopy and colposcopy services) in an NHS, University-affiliated Teaching Hospital (Birmingham Women's & Children's Hospital (BWCH) in the UK.

Identification of participants:

Eligible women will be identified by a member of the clinical team responsible for the direct care of the potential participant in outpatient gynaecology clinics and pre-operative assessment clinics in each recruiting centre. Additionally, patients already on the waiting list for SDD LH will be identified and invited to participate. The study will be introduced by a member of the clinical or research team, with full counselling about the trial. The potential participant will be advised that participation in the study is entirely voluntary with the option of withdrawing from the study at any stage. It will be made clear that participation or non-participation will not affect their usual care.

Assessment of Risk:

SDD LH is routinely practiced at the BWCH. Verbal and written, paper-based information is provided. This study provides additional, on-line, multi-media information on a specifically designed website for SDD LH. Thus, this trial is categorised as: Type A = No higher than the risk of standard medical care.

Eligibility

Women are eligible for recruitment if they meet the inclusion criteria and do not have any of the exclusion criteria set out below:

Inclusion Criteria:

• Able to give informed consent to participate

• Have a benign gynaecological condition that is being treated with a LH

• Eligible to be on same day discharge pathway Patient factors

• American Society of Anesthesiologists (ASA) physical status classification 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Able to give informed consent to participate

• Have a benign gynaecological condition that is being treated with a LH

• Eligible to be on same day discharge pathway Patient factors

1. ASA I/II with no sleep apnoea. ASA III may be suitable if comorbidities are stable and optimised.

2. No known cardio-pulmonary compromise

3. No known renal disease

4. Age </= 60 years

5. BMI </=40

6. Not indication for admission to Gynaecological Extended Recovery Area (GERU)

• Surgical factors

1. Presumed benign disease

2. No anticipated surgical complications

3. Concomitant procedures acceptable but surgeon to decide on a case by case basis Discharge factors

4. Residence < 1 hour from BWCH

5. 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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Birmingham Women's and Children's NHS Foundation Trust

References & Publications (8)

Bailey CR, Ahuja M, Bartholomew K, Bew S, Forbes L, Lipp A, Montgomery J, Russon K, Potparic O, Stocker M. Guidelines for day-case surgery 2019: Guidelines from the Association of Anaesthetists and the British Association of Day Surgery. Anaesthesia. 2019 Jun;74(6):778-792. doi: 10.1111/anae.14639. Epub 2019 Apr 8. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, MacFie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):783-800. doi: 10.1016/j.clnu.2012.08.013. Epub 2012 Sep 28. — View Citation

Lonky NM, Mohan Y, Chiu VY, Park J, Kivnick S, Hong C, Hudson SM. Hysterectomy for benign conditions: Complications relative to surgical approach and other variables that lead to post-operative readmission within 90 days of surgery. Womens Health (Lond). 2017 Aug;13(2):17-26. doi: 10.1177/1745505717714657. Epub 2017 Jun 29. — View Citation

Madhvani K, Curnow T, Carpenter T. Route of hysterectomy: a retrospective, cohort study in English NHS Hospitals from 2011 to 2017. BJOG. 2019 May;126(6):795-802. doi: 10.1111/1471-0528.15539. Epub 2018 Dec 30. — View Citation

Moawad G, Liu E, Song C, Fu AZ. Movement to outpatient hysterectomy for benign indications in the United States, 2008-2014. PLoS One. 2017 Nov 30;12(11):e0188812. doi: 10.1371/journal.pone.0188812. eCollection 2017. — View Citation

Perino A, Cucinella G, Venezia R, Castelli A, Cittadini E. Total laparoscopic hysterectomy versus total abdominal hysterectomy: an assessment of the learning curve in a prospective randomized study. Hum Reprod. 1999 Dec;14(12):2996-9. doi: 10.1093/humrep/ — View Citation

Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open abdominal versus laparoscopic and vaginal hysterectomy: analysis of a large United States payer measuring quality and cost of care. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):581-8. doi: 10.1016/j.jmig.2009.06.018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Same Day Discharge following laparoscopic hysterectomy (0-23hours)	This means that the patient is discharged (leaves the hospital) before midnight on the day of surgery (case notes / electronic patient record).	0-24hours following surgery
Secondary	Satisfaction with care on discharge (bespoke patient questionnaire score)	Patient satisfaction of same day discharge following laparoscopic hysterectomy (LH). protocol. This will be assessed through bespoke patient questionnaire.	0-24hours following surgery
Secondary	Acceptability and utility of patient education / information provided (score)	Patient satisfaction of acceptability and utility of patient education / information provided. This will be assessed through bespoke patient questionnaire.	6 weeks
Secondary	Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score)	Patient's satisfaction with clinical outcome after laparoscopic hysterectomy (LH) through(5-point Likert)	6 weeks
Secondary	Satisfaction with care on discharge (score)	Patient's satisfaction with care on discharge through bespoke patient questionnaire	6 weeks
Secondary	Generic quality of life post-surgery (score)	Patient's Quality of life score using EuroQol-5D-5L questionnaire	6 weeks
Secondary	Generic quality of life post-surgery (score)	Patient's Quality of life score using EuroQol-5D-5L visual analogue scale	6 weeks
Secondary	Contact with Community & Clinical Care Services	Serious Adverse Events through case report forms (CRF)	6 weeks
Secondary	Time from surgery to resumption of usual activities in days	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.	6-12 weeks
Secondary	Time to return to work (if working) in days	This will be assessed using bespoke patient questionnaire	6-12 weeks

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