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

NCT06011538 | Unknown

• 1 other identifier: BirminghamWCNHSFT
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Hysterectomy; LAP

Keywords

Same day discharge; Laparoscopic hysterectomy; Educational platform; Enhanced recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Satisfaction with care on discharge (bespoke patient questionnaire score)

  0-24hours following surgery

• Acceptability and utility of patient education / information provided (score)

  6 weeks

• Satisfaction with clinical outcome after laparoscopic hysterectomy (LH) (score)

  6 weeks

• Satisfaction with care on discharge (score)

  6 weeks

• Generic quality of life post-surgery (score)

  6 weeks

Study Arms (2)

On-line SDD LH website resource (intervention)

EXPERIMENTAL

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.

Other: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy

Standard practice for information provision (control)

ACTIVE COMPARATOR

Patients allocated the control group will receive standard BWCH information only.

Other: On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy

Interventions

On-line, multi-media information on a specifically designed website for Same Day Discharge following Laparoscopic Hysterectomy OTHER

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.

On-line SDD LH website resource (intervention); Standard practice for information provision (control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Related Publications (8)

• 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.

  PMID: 28660800 BACKGROUND

• 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.

  PMID: 30461181 BACKGROUND

• 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.

  PMID: 29190666 BACKGROUND

• 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.

  PMID: 19835801 BACKGROUND

• 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.

  PMID: 30963557 BACKGROUND

• 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.

  PMID: 23099039 BACKGROUND

• 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.

  PMID: 19638912 BACKGROUND

• 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/14.12.2996.

  PMID: 10601085 RESULT

Related Links

• Related Info
• Related Info

Study Officials

• TJustin Clark, MD, FRCOG

  Birmingham Women's and Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Antoun, MD, MRCOG

CONTACT

044 7518613461; lina.antoun1@nhs.net

Paul Smith, MD, MRCOG

CONTACT

paul.smith54@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share