NCT02345954|Unknown
Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
HysPex
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HysPex
Sponsor study identifier
interventional
100
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2014
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 26, 2015
Actual (reported)October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Operation time
Comparison of operation time in the 2 arms of the study
expected average of 150 minutes
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
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Quality of Life
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic Hysteropexy
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
Laparoscopic hysteropexy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kantonsspital Aarau
Aarau, Aargau (AG), 5001, Switzerland
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.
Dimitri Sarlos, MD
Kantonsspital Aarau
First Submitted
November 21, 2014
First Posted
January 26, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2022
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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