Benign gynaecological conditions requiring a hysterectomy Urological and Genital Diseases
Conditions
Interventions
Before their operation, women who agree to take part in the LAVA study will fill in some questionnaires that will measure their quality of life, bladder and bowel function, as well as selecting some u
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged at least 16 years of age or over and able to give informed consent to participate 2. Has a benign gynaecological condition that is being treated with a hysterectomy 3. This hysterectomy can be undertaken by either a laparoscopic or open abdominal route
Exclusion criteria
Exclusion criteria: 1. Women with suspected malignant disease of the genital tract 2. Women who require concomitant gynaecological surgery, or bladder or other pelvic support 3. Women who require excision of endometriosis requiring dissection of the pararectal space
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major surgical complications defined as Clavien-Dindo grade III-V, including pulmonary embolus, blood transfusion or adverse anaesthetic event up to and including 6 weeks post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to full physical recovery (resumption of usual activities) measured using Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) item bank v1.2. The participant will record the date when each of her eight pre-selected physical activities is achieved using a text application. Weekly text reminders will be sent to complete the PROMIS-PF during the first 6 weeks, fortnightly from 6 to 12 weeks and three weekly up to 54 weeks. Once all eight activities are achieved text reminders will stop. 2. In-hospital postoperative pain reported by the participant up to (and including) the day of discharge 3. In-hospital postoperative analgesia use reported by the medical or nursing staff up to (and including) the day of discharge 4. Quality of recovery measured using Quality of Recovery 15 (QoR-15) completed by the participant before their discharge from the hospital 5. Time to discharge calculated from the admission and discharge information provided by the clinical staff on CRFs after discharge 6. Post-operative pain and analgesia use measured using the numerical rating scale (NRS) post-operatively and at time of discharge 7. Generic quality of life measured using EuroQol-5D-5L and VAS at 6 and 12 weeks post-surgery and again at 15 months post-randomisation. These outcomes will be collected also at 27 and 39 months post-randomisation for subgroups of participants reaching these timepoints prior to the close of the study 8. Time to return to work (if working) and work participation measured using the Work Productivity and Activity Impairment Questionnaire (WPAI–GH) at 12 weeks post-surgery 9. Bladder function measured using the Urogenital Distress Inventory (UDI) at 15 months post-randomisation. These outcomes will be collected also at 27 and 39 months post-randomisation for subgroups of participants reaching these timepoints prior to the close of the study 10. Bowel function measured using the Defecatory Distress Inventory (DDI) at 15 | — |
Countries
England, United Kingdom
Contacts
Public ContactWilliam McKinnon
Outcome results
None listed