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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supracervical Hysterectomy and Sacropexy | Experimental | Laparoscopic Supracervical Hysterectomy and Sacropexy |
|
| Hysteropexy | Experimental | Laparoscopic Hysteropexy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Supracervical Hysterectomy and Sacropexy | Procedure | Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Comparison of operation time in the 2 arms of the study | expected average of 150 minutes |
| 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) |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitri Sarlos, MD | Contact | +41 838 5065 | dimitri.sarlos@ksa.ch | |
| Jean-Jacques Ries, MD | Contact | +41 838 5995 | Jean-Jacques.Ries@ksa.ch |
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Sarlos, MD | Kantonsspital Aarau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Recruiting | Aarau | Aargau (AG) | 5001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22914470 | Background | Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a. | |
| 19935030 | Background | Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96. |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Laparoscopic Hysteropexy | Procedure | Laparoscopic hysteropexy |
|
| 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 |
| 23298608 | Background | Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5. |
| 16319998 | Background | Krause HG, Goh JT, Sloane K, Higgs P, Carey MP. Laparoscopic sacral suture hysteropexy for uterine prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):378-81. doi: 10.1007/s00192-005-0019-0. Epub 2005 Nov 30. |
| 20002370 | Background | Price N, Slack A, Jackson SR. Laparoscopic hysteropexy: the initial results of a uterine suspension procedure for uterovaginal prolapse. BJOG. 2010 Jan;117(1):62-8. doi: 10.1111/j.1471-0528.2009.02396.x. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |