Uterus Prolapse
Conditions
Keywords
Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy
Brief summary
The purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus). The investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.
Interventions
PROCEDURELaparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
PROCEDURELaparoscopic Hysteropexy
Laparoscopic hysteropexy
Sponsors
Kantonsspital Aarau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Symptomatic uterus prolapse (uterus \< 300g) * Patient able to sign the informed consent and to fulfil the follow up visits
Exclusion criteria
* Indication: Pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (\>5 mm), abnormal PAP smear in the last 5 years, bleeding anomalies in premenopausal patients * General medical contraindications to a surgical operation * tumor/ malignant disease * bacterial infection at time of surgery * drug or medication abuse at time or just before surfer * Disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition) * Known hypersensitivity to the implanted materials * Immaturity, inability to answer/understand questions * Planned pregnancy * Participation to other studies (drugs or medical techniques) which could influence the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | expected average of 150 minutes | Comparison of operation time in the 2 arms of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of anaesthesia | expected average of 200 minutes | — |
| IUGA Pelvic Organ Prolapse Quantification (POP-Q) | 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention | — |
| Intra- and postoperative complication rate | 1 year | — |
| Quality of Life | 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention | EQ-5D-5L questionnaire |
| Patient satisfaction after surgery | At follow up 6 weeks, 6 months and 12 months after intervention | — |
| Bladder and bowel function, Prolapse symptoms, Sexuality | 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention | Assessed via Pelvic Function Questionnaire |
Countries
Switzerland
Contacts
Primary ContactDimitri Sarlos, MD
Backup ContactJean-Jacques Ries, MD
Outcome results
None listed