A Randomised Trial to Compare the Differences Between Monopolar Surgery (Loop Resection) With Glycine 1,5% and Bipolar Surgery With Saline (Olympus,Versapoint) on Hysteroscopic Surgery.
- Trial design: A prospective randomised study with three arms, one arm with monopolar
surgery and two different arms with bipolar surgery. Its a one center study.
- Trial population: Pre-or perimenopausal women reffered to our clinic with bleeding
disorders and were we plan to do endometrial resection. Patients with a bleeding
disorder due to fibroids type 0 and 1 will be included and patients with polyps were
endometrial resection is planned at the same time will also be included.
- Preoperative selection: The fibroids will be mapped using transvaginal ultrasound
according to the classification ESGE. Type 0 and 1 fibroids will be included. Diameter
of the fibroid must not extend 4cm. The endometrium size double layer will be recorded.
Uterine size anetrior /posterior diameter, longitudinal diameter (cavity; top fundal to
isthmus) will be measured. Were polyps are included these will be measured; length and
width. Higham score (PBAC), Se-hgb, Ferritin, FSH and Oestradiol will be documented at
all visits. Menstrual pain will be documented due to a VAS-scale.
- Treatment regimen:Randomisation in blocs of 20 between monopolar and two types of
- Surgical Technique: The cervical canal will be dilated to Hegar 10 or 11 and a rigid
resectoscope Ch. 26 is passed to the uterine cavity. Glycine 1,5% or Saline (Baxter) is
infused to irrigate the uterine cavity (Iglesias technique) Automatic pressure cuff
maintains an infusion pressure of 100mm Hg and suction 10-15mmHg is applied to the
outflow tube in order to achieve a sufficient flow.Fibroids type 0 and 1 are resected
in total if possible or flush to the plane of the uterine wall. The tissue chips are
removed at intervals by currette and forceps. The operation will be performed by
- Primary response variables: Safety is our primary response variable. Fluid absorption
and lowering of Se-Sodium will be analysed. These parameters are the only objective
parameters which can tell us about safety. Nausea will be reorded on a VAS-scale.
- Secondary resonse variables: Operating time, tissue removed, easisness of
operation, levels of vaginal bleeding measured by the methosd of Hgham(PBAC)before
and at follow up.
After 6 month and one year we will look at secondary intervention like repeated resection or
Olav Istre, MD., PhD.
Department of Gynaecology, Ullevaal University Hospital, Oslo, Norway
Norway:National Committee for Medical and Health Research Ethics