Psysician Martin Rudnicki Department of Gynaecology and Obstetrics, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
LESS - Levonorgestrel endometrial surgery study - Combined endometrial surgery and Levonorgestrel Device treatment for heavy menstrual bleeding
Surgery, especially hysterectomy but also hysteroscopic resection/ablation effectively reduces menstrual bleeding, but so far there is no concluding evidence that surgery improves patients satisfaction compared to Levonorgestrel Intrauterine Divice treatment .
Although hysterectomy is associated with the best outcome regarding impact on heavy bleeding, several serious complications may appear. Thus, LNG-IUS and endometrial resection or ablation appears to be safe.
So far, both LNG-IUS and endometrial generation therapy do not ameliorate bleeding and thus a rather high number of women seem not to be satisfied with the treatment. Recent studies report a secondary hysterectomy rate of 27% or even more of women offered surgical ablation or resection treatment .
One option to overcome this may be to combine conservative surgical treatment and LNG-IUS. Recently a cohort study demonstrated that none of the women who underwent combined treatment had hysterectomy for treatment failure compared with 24% in the endometrium ablation group; significantly lower postablation pelvic pain and only one woman presented with persistent bleeding compared with 23.1% in the endometrial group.
The present study is undertaken to test the hypothesis that a combined conservative surgical treatment and (endometrial ablation or resection, EA) and LNG-IUS increase the rate of amenorrhoea by 20% (from In average 60% to 40%)
Secondary endpoints are: To test the hypothesis that combined conservative surgical treatment lower postsurgical pain by 10% and hysterectomy rate by 15%.
Description of the cohort
The study is performed as a prospective cohort study. In total 220 women will be included. The anticipated inclusion period is 1 year. The patients will be asked to fulfill questionnaires at inclusion, 6 months, 1 and 5 years after the surgical procedure
Women with menorrhagia or metrorhagia who are submitted for surgical ablation or resection
Normal PAP smear within the latest 12 months
Normal endometrial pathology within the latest 6 months
Uterine cavity 4-12 cm
Submucous myoma or polyps below 1 cm
No fertility issues
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Data and biological material
MIC (Menorrhagia Impact Questionnaire)
PGI-I and PGI-S
Pain diary VAS
Collaborating researchers and departments
Department of Gynaecology and Obstetrics, Hospital of Southern Jutland
Consultant Leif Messerschmidt
Consultant Bo Sultan
Department of Gynaecology and Obstetrics, Kolding Hospital
Consultant Jane Buch Sørensen
Consultant Pia Kirstine Berthelsen
Department of Gynaecology and Obstetrics, Esbjerg Hospital
Consultant Troels Kragsig Thomsen
Consultant Anna Cyrus Consultant
Consultant Karolina Magdalena Dabek Schousboe
Department of Gynaecology and Obstetrics, Odense University Hospital