Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia . In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Use of the Lina LibrataTM
Hospices Civils de Lyon
Bron, France
rate of amenorrhea
Time frame: 4 weeks
pain score
Pain at Hour 0 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time frame: during surgery (Hour 0)
pain score
Pain at Hour 2 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time frame: 2 hours after surgery (Hour 2)
pain score
Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Time frame: 6 hours after surgery (Hour 6)
pain score
Pain at Hour 6 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain)..
Time frame: 6 hours after surgery (Hour 6)
pain score
Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Time frame: the day after surgery (Day 1)
pain score
Pain at Day 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time frame: the day after surgery (Day 1)
pain score
Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Time frame: one week after surgery (Day 7)
pain score
Pain at Day 7 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time frame: one week after surgery (Day 7)
pain score
Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Time frame: one month after surgery (Month 1)
pain score
Pain at Month 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time frame: one month after surgery (Month 1)
recurrences of menorrhagia
Time frame: at month 1
recurrences of menorrhagia
Time frame: at month 6
assessment of menorrhagia on Higham's score
Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood.
Time frame: 1 month after surgery
assessment of menorrhagia on Higham's score
Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood.
Time frame: 6 months after surgery
evolution of hemoglobinemia
hemoglobin measured by blood test
Time frame: 1 month after surgery
evolution of hemoglobinemia
hemoglobin measured by blood test
Time frame: 6 months after surgery
per-operative complications
Time frame: per surgery day 0
post-operative complications
Time frame: post surgery day 0
measure of quality of life
assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50.
Time frame: at month 1
measure of quality of life
assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50.
Time frame: at month 6
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Time frame: at month 1
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Time frame: at month 6
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