Abnormal Uterine Bleeding / Niche resection Surgery
Conditions
Interventions
This is an observational study of an intervention, laparoscopic niche resection.
There is only one study arm. The laparoscopic niche resection/reconstruction is an operative laparosco
Sponsors
VU University Medical Center (Netherlands)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. A niche with residual myometrium < 3 mm (as measured with SIS / GIS) 2. Complaints of abnormal uterine blood loss, dysmenorrhoea or accumulation of intracavitary fluid 3. Premenopausal women aged above 18
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Age below 18 3. Other disorders that may induce spotting [polyps (everywhere in the uterus/cervix are exclusion criteria except those in the niche)], fibroids, known atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, assumed malignancy, irregular cycle (>35 days or intercycle variation of 2 weeks or more) 4. Contra-indications for spinal or general anaesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of abnormal uterine blood loss in days, measured at baseline and after 3, 6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (SF36) 2. Dysmenorrhoe 3. Fertility/pregnancy 4. Intracavitary accumulation of fluid All above outcomes measured at baseline and after 3, 6, 9 and 12 months | — |
Countries
Netherlands
Outcome results
None listed