Page 95 - The diagnostic work-up of women with postmenopausal bleeding

Hypothesis
Uterine cavity evaluation and subsequent resection of endometrial polyps in women with postmenopausal bleeding and endometrial thickness of more than 4 mm will lead to less recurrent bleeding compared to women in whom such is not performed.
Informed consent, randomisation and masking
The local doctor or research nurse enrolled the participants and assigned them to
the randomised intervention. Before randomisation participating women provided
written informed consent, in which they were informed about the possible risks
and complications of SIS and hysteroscopy. Women were randomised to receive
either SIS and hysteroscopy or expectant management, using a web based program,
using block randomisation with a block size of four, an allocation ratio of 1:1 and
stratification for hospital.The web-based program generated a unique number with
allocation code after entry of the patient’s initials and date of birth.Neither recruiting
doctors nor members of the trial project group could access the randomisation 5 sequence.Due to the nature of the intervention the study was open-label,as it meant
that masking women and doctors to the assigned intervention was not possible.The statistician doing the analysis (HZ) was masked to the assigned intervention, while those who collected follow-up data were not.
Intervention
Women allocated to diagnostic work-up all underwent SIS and hysteroscopy in the same outpatient session, within six weeks after randomisation. At SIS, a small volume of saline was inserted into the uterus, which allowed the lining of the endometrium and possible polyps to be clearly seen on an ultrasound scan. Regardless of the result, a hysteroscopy was done, using a vaginoscopic approach with a 4 to 5.5 mm hysteroscope, according to the local protocol.The hysteroscopy was performed by the local gynaecologist with experience in hysteroscopy.When a polyp was detected, immediate polypectomy was performed, by using scissors, a polyp snare or a bipolar electrode (Versapoint®). In a case of thickened or irregular endometrium, a biopsy was taken by a grasping forceps and in case of atrophic endometrium, the doctor could decide on endometrial biopsy, as this is according to the Dutch guideline8.When outpatient hysteroscopy was not feasible or a polyp could not be removed completely, the patient underwent hysteroscopy under regional or general anaesthesia.
Woman allocated to expectant management did not receive any specific fur ther diagnostic work-up or treatment.
Diagnostic work-up: a RCT
93