Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
NCT ID: NCT02345954
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2023-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Supracervical Hysterectomy and Sacropexy
Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
Hysteropexy
Laparoscopic Hysteropexy
Laparoscopic Hysteropexy
Laparoscopic hysteropexy
Interventions
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Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
Laparoscopic Hysteropexy
Laparoscopic hysteropexy
Eligibility Criteria
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Inclusion Criteria
* Symptomatic uterus prolapse (uterus \< 300g)
* Patient able to sign the informed consent and to fulfil the follow up visits
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Kantonsspital Aarau
OTHER
Responsible Party
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Dimitri Sarlos
Chair Department of Gynecology
Principal Investigators
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Dimitri Sarlos, MD
Role: STUDY_CHAIR
Kantonsspital Aarau
Locations
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Kantonsspital Aarau
Aarau, Aargau (AG), Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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lapSKPvslapHP
Identifier Type: -
Identifier Source: org_study_id
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