Uterus Prolapse Clinical Trial
— HysPexOfficial title:
Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | October 2023 |
| Est. primary completion date | October 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Kantonsspital Aarau | Aarau | Aargau (AG) |
| Lead Sponsor | Collaborator |
|---|---|
| Kantonsspital Aarau |
Switzerland,
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. Review. — View Citation
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. Epub 2005 Nov 30. — View Citation
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. — View Citation
Sarlos D, Kots L, Stevanovic N, von Felten S, Schär G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a. — View Citation
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):1278-83. doi: 10.1097/AOG.0b013e3181c2ce96. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Operation time | Comparison of operation time in the 2 arms of the study | expected average of 150 minutes | |
| Secondary | Intra- and postoperative complication rate | 1 year | ||
| Secondary | Duration of anaesthesia | expected average of 200 minutes | ||
| Secondary | 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 | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Patient satisfaction after surgery | At follow up 6 weeks, 6 months and 12 months after intervention |