None listed
Conditions
Brief summary
Currently at our institution (Mercy Hospital for Women), approximately 12 women are referred each week for postmenopausal bleeding, or 600 per annum. These women are then seen in the outpatient gynaecology department in any one of four clinics. Pelvic ultrasonography is used as a binary differentiator, as a risk predictor for endometrial cancer. If the endometrial thickness (lining of the womb) is below a certain level (4mm as per national and international guidelines), the risk of endometrial cancer is less than 1%, and thus endometrial sampling is not indicated, in the absence of recurrent episodes or high-risk features. Unfortunately, the time from referral to our clinics, to the time of notification of the histological diagnosis (and thus options for definitive management) is usually 12 weeks at best. The effect of this delay is 2-fold; 1) we believe patients may experience anxiety and frustration at the delay to review and diagnosis, particularly when concerns regarding endometrial cancer have been raised, and 2) seeing women in the outpatient clinic with a normal endometrial thickness (<4mm) is unnecessary, when sampling is not required. We believe these women can be safely managed in the community by their local general practitioner. We thus plan to randomise patients referred to the Endosurgery B unit to either routine care (with outpatient ‘in-person’ clinic review) or a ‘virtual clinic’ utilising telephone consultation with a gynaecologist after pelvic ultrasound results are known. We suspect outcomes to indicate: 1. more efficient throughput of patients with postmenopausal bleeding 2. a change in patient satisfaction impacted by faster contact and review, and individual acceptance of the telephone clinic model 3. clinician satisfaction upon seeing improved efficiency in the management of this common problem 4. shorter outpatient clinic wait times
Interventions
Intervention: A virtual clinic model was established for those randomised to the intervention group. This model involved a streamlined assessment of the referral by the gynaecology fellow and use of the endometrial thickness (ET) threshold of 4mm to dichotomise those women who were at low and intermediate/high risk of endometrial cancer. Those with an endometrial thickness 4mm or less and without additional risk factors for endometrial cancer were mailed information (a study-specific letter) reg
Intervention: A virtual clinic model was established for those randomised to the intervention group. This model involved a streamlined assessment of the referral by the gynaecology fellow and use of the endometrial thickness (ET) threshold of 4mm to dichotomise those women who were at low and intermediate/high risk of endometrial cancer. Those with an endometrial thickness 4mm or less and without additional risk factors for endometrial cancer were mailed information (a study-specific letter) regarding vaginal atrophy, and usual management with topical oestrogen, along with contact details if any concerns. A follow-up phone call of 5-10minutes duration by the gynaecological fellow occurred at 3months; this included: assessment as to whether any repeat episodes of PMB had occurred, and whether any additional risk factors had developed. All those with an endometrial thickness >4mm had their referral assessed by the gynaecology fellow for contraindications to outpatient hysteroscopy. In the absence of contraindications, these women were phoned and had their condition explained, and the recommendation for a hysteroscopy. This was suggested as an outpatient procedure as first line. Those who accepted this model were booked directly to the outpatient hysteroscopy clinic for a same-day ‘see-and-sample’ appointment. This appointment involved a routine history-taking assessment by a gynaecologist (approximately 10minutes) followed by consent for procedure. The outpatient hysteroscopy was then performed, with subsequent endometrial biopsy (with pipelle) or Myosure(TM) intrauterine morcellation if a polyp was found. Awake outpatient hysteroscopies generally take 10-20minutes. Those who were unsuitable or who declined outpatient hysteroscopy, along with those randomised to the control group underwent routine care with outpatient clinic appointment and sampling as an inpatient at a later date as deemed appropriate.
Sponsors
Mercy Hospital for Women
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Postmenopausal (by definition, cessation of menstrual periods (in the absence of hormonal suppression) for at least 12months (average age of menopause is 51-52yrs) 2. Referred from primary care with an episode (at least one) of postmenopausal vaginal bleeding 3. English-speaking
Exclusion criteria
1. additional pathology or symptomatology (eg abdominal pain, pelvic mass, prolapse etc) 2. non-english speaking 3. non-consenting 4. incomplete referral
Outcome results
None listed