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)

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 \

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 \

IPD will only be shared as part of results in a peer reviewed publication. No specific or individual participant data will be shared