Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial

Conditions
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Uterus Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy
* Procedure: Laparoscopic Hysteropexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supracervical Hysterectomy and Sacropexy<br>Laparoscopic Supracervical Hysterectomy and Sacropexy | Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy<br>* Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy<br>|
| Experimental: Hysteropexy<br>Laparoscopic Hysteropexy | Procedure: Laparoscopic Hysteropexy<br>* Laparoscopic hysteropexy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Comparison of operation time in the 2 arms of the study | expected average of 150 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and postoperative complication rate |  | 1 year | 
| 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 | 
| Bladder and bowel function, Prolapse symptoms, Sexuality | Assessed via Pelvic Function Questionnaire | 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention | 
| Quality of Life | EQ-5D-5L questionnaire | 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention | 
| Patient satisfaction after surgery |  | At follow up 6 weeks, 6 months and 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy