Optimum intrauterine filling pressures needed to perform outpatient diagnostic hysteroscopy

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: Women who are due to undergo an outpatient hysteroscopy procedure will be recruited after obtaining informed consent. They will be allocated to one of the three pressure groups (100mmHg, 70mmHg or 40mmHg) using computer generated random numbers sealed in an opaque envelope which is opened by the attending nurse or healthcare assistant who sets up the pressure of distension medium. The woman and the operator will be blinded to the allocated pressure. The hysteroscopy procedure will be performed by an experienced operator who will judge whether the uterine distension is adequate or inadequate. At this point the women will be asked to report her pain score between 0 to 10, using a Visual Analogue Scale. If the visualisation of the uterine cavity is inadequate, the operator will then ask the nurse/healthcare assistant to establish the pressure to 100 mmHg, which is the standard distension pressure used in the department to complete the procedure. Any additional necessary procedures such as biopsy, polyp or fibroid removal will be carried out after the assessment of the operator and the woman. CONDITION: Hysteroscopy ; Surgery ; Hysteroscopy PRIMARY OUTCOME: Adequate visualisation of the uterine cavity assessed at the same point when the operator judges whether the visualisation is adequate or inadequate SECONDARY OUTCOME: Visual Analogue Score (VAS) pain score assessed at the same point when the operator judges whether the visualisation is adequate or inadequate INCLUSION CRITERIA: 1. Women who are referred for an outpatient hysteroscopy procedure at the Univesity College London Hospitals 2. Those who give informed consent to participate in the trial
Epistemonikos ID: 78c4125e79c46681fbde39dc58e6d3b96221ef88
First added on: Aug 22, 2024