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

NCT06011538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • TJustin Clark, MD, FRCOG · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-12-31
Completion
2024-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011538 on ClinicalTrials.gov