Heavy menstrual bleeding Urological and Genital Diseases Heavy periods NOS
Conditions
Interventions
The patients are randomised to two groups.
The interventions being compared are:
1. Laparoscopic supra-cervical hysterectomy (LASH):
The LASH procedure involves removing the part of your womb that c
Sponsors
University of Aberdeen/NHS Grampian (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women less than 50 years of age with heavy menstrual bleeding eligible for endometrial ablation 2. Women who are willing to be randomised between laparoscopic supra-cervical hysterectomy and endometrial ablation
Exclusion criteria
Exclusion criteria: 1. Women with plans to conceive, endometrial atypia, uterine cavity size greater than 11 cm, submucosal fibroids distorting the uterine cavity, contradictions for laparoscopic surgery (e.g. midline lower abdominal incision or known intrabdominal / pelvic adhesions) and previous endometrial ablation (EA) 2. Women who are unable to give informed consent or complete trial documentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Menorrhagia multi-attribute scale (MMAS), a condition-specific Quality of Life outcome 2. Patient satisfaction, measured on a six point scale (from ?totally satisfied? to ?totally dissatisfied?) measured at 12 months post surgery 3. Incremental cost (to the health service) per quality-adjusted life year (QALY) gained (LASH versus EA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/05/2023: Patient-reported: 1. MMAS at 6 months and 5-8 years post-randomisation 2. Patient-reported satisfaction at 6 months and 5-8 years post-randomisation 3. Acceptability of procedure measured at 6 weeks 4. Severity of postoperative pain using a pain Numerical Rating Scale (NRS) measured at 1-14 days and at 6 weeks, symptom diary days 1 to 14 (including analgesic use) 5. Generic health-related quality of life (SF-12, EQ-5D 3-L) measured at baseline, 6 months, 12 months and 5-8 years post-randomisation 6. Sexual Activity Questionnaire (SAQ) at baseline, 6 and 12 months Clinical 1. Duration of operation 2. Peri-operative complications and recovery details including analgesia requirements 3. Time to discharge 4. Further gynaecological surgery in 12 months and 5-8 years post-randomisation Economic Wider societal costs associated with changes in productivity based on information on the time taken to return to normal activities (following intervention) combined with questions on work productivity delivered during the follow-up period. Further, a simple Markov model, based on within trial data supplemented by available published data on the requirement for further gynaecological surgery over time (following the alternative procedures) will be developed and used to extrapolate cost-effectiveness beyond 12 months. Previous secondary outcome measures: Patient reported: 1. MMAS at 6 months 2. Patient reported satisfaction at 6 months 3. Acceptability of procedure measured at 6 weeks 4. Severity of post operative pain using a pain Numerical Rating Scale (NRS) measured at 1-14 days and at 6 weeks, symptom diary days 1 to 14 (including analgesic use) 5. Generic health related quality of life (SF-12, EQ-5D 3-L) measured at baseline, 6 and 12 months 6. Sexual Activity Questionnaire (SAQ) at baseline, 6 and 12 months Clinical 1. Duration of operation 2. Peri-operative complications and recovery details including analgesia require | — |
Countries
Scotland, United Kingdom
Outcome results
None listed