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POMPOEN

Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding. (Postmenopausaal bloedverlies onderzoek.)

 

Go to the Pompoen website.



Rationale
Postmenopausal bleeding occurs in approximately 15,000 women per year, and may signal serious underlying medical problems. The Dutch guideline on the work-up for postmenopausal bleeding emphasises diagnosing malignant pathology of the endometrium. Transvaginal sonography is used to measure endometrial thickness, if the endometrial thickness measures more than 4 mm, endometrium aspiration (using a Pipelle) is advocated to rule out or diagnose endometrial carcinoma. when malignancy has been ruled out, it is uncertain whether the work-up should be continued with SIS and/or hysteroscopy (and subsequent polypectomy when an abnormality is detected), if at all. The present proposal will study the effects of these strategies. The proposal will consider medical effectiveness.

Objective
SIS and hysteroscopy in the work-up for postmenopausal bleeding will be studied. Medical effectiveness in terms of treatment of the postmenopausal bleeding will be evaluated. To assess which women need saline-infused sonography and/or hysteroscopy, if at all, we will answer the following questions:
What are the effects of the following strategies:
1. no further testing after carcinoma has been ruled out
2. SIS for all patients, and hysteroscopy after abnormal SIS
3. immediate hysteroscopy for all patients
4. targeted selection of patients at increased risk for polyps.

Study design
Multicenter randomized trial.

Study population
Patients with postmenopausal bleeding and an endometrial thickness of more than 4 mm, in whom through endometrial biopsy malignancy could be ruled out.

Intervention
Patients will be randomised for a subsequent diagnostic work-up with SIS and hysteroscopy or no further diagnostic work-up. In case the patient is allocated to no diagnostic work-up, she will be sent home without further diagnostic tests. She will be instructed to contact the gynaecologists in case of recurrence of vaginal bleeding.

Outcome measures
Primary outcome: Recurrence of postmenopausal bleeding.

Power/data analysis
We expect the probability of recurrence of menstrual bleeding without SIS/hysteroscopy to be 40%. A strategy with SIS/hysteroscopy is thought to reduce this percentage to 20% to make such a strategy cost-effective. We anticipate a drop-out rate of the study of 20%. When we use a two-sides test, we need 200 patients randomised to two groups of 100 patients to show such a difference (alpha error .05, beta error .20).

Time schedule
Inclusion period 12 months, follow up period 12 months

Projectleaders
Prof. Dr. B.W.J. Mol, AMC, Amsterdam

Study coordination
Drs. M.C. Breijer, TweeSteden Ziekenhuis, Tilburg

Study group
Drs. S. Veersema, St. Antonius Ziekenhuis, Nieuwegein
Dr. J.M.A. Pijnenborg, TweeSteden Ziekenhuis, Tilburg
Dr. A. Timmermans, TweeSteden Ziekenhuis, Tilburg
Dr. M.Y. Bongers, Maxima Medisch Centrum, Veldhoven

Contact
Merel Breijer, arts-onderzoeker
TweeSteden Ziekenhuis Tilburg
Mobiel: 06-41269280
E-mail: pompoen@studies-obsgyn.nl