Short summary

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. 

Rationale

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

Inclusion criteria

• 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

Data and biological material

MIC (Menorrhagia Impact Questionnaire) 

PGI-I and PGI-S

Bleeding pattern/

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

• Consultant Bente Pedersen 
• Associate Professor Pernille Ravn
• Associate Professor Martin Rudnicki