Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study (HysPex)
Primary Purpose
Uterus Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic Hysteropexy
Sponsored by
About this trial
This is an interventional treatment trial for Uterus Prolapse focused on measuring Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy
Eligibility Criteria
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
Sites / Locations
- Kantonsspital AarauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supracervical Hysterectomy and Sacropexy
Hysteropexy
Arm Description
Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic Hysteropexy
Outcomes
Primary Outcome Measures
Operation time
Comparison of operation time in the 2 arms of the study
Secondary Outcome Measures
Intra- and postoperative complication rate
Duration of anaesthesia
IUGA Pelvic Organ Prolapse Quantification (POP-Q)
Bladder and bowel function, Prolapse symptoms, Sexuality
Assessed via Pelvic Function Questionnaire
Quality of Life
EQ-5D-5L questionnaire
Patient satisfaction after surgery
Full Information
NCT ID
NCT02345954
First Posted
November 21, 2014
Last Updated
September 1, 2020
Sponsor
Kantonsspital Aarau
1. Study Identification
Unique Protocol Identification Number
NCT02345954
Brief Title
Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
Acronym
HysPex
Official Title
Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus Prolapse
Keywords
Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supracervical Hysterectomy and Sacropexy
Arm Type
Experimental
Arm Description
Laparoscopic Supracervical Hysterectomy and Sacropexy
Arm Title
Hysteropexy
Arm Type
Experimental
Arm Description
Laparoscopic Hysteropexy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Supracervical Hysterectomy and Sacropexy
Intervention Description
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Hysteropexy
Intervention Description
Laparoscopic hysteropexy
Primary Outcome Measure Information:
Title
Operation time
Description
Comparison of operation time in the 2 arms of the study
Time Frame
expected average of 150 minutes
Secondary Outcome Measure Information:
Title
Intra- and postoperative complication rate
Time Frame
1 year
Title
Duration of anaesthesia
Time Frame
expected average of 200 minutes
Title
IUGA Pelvic Organ Prolapse Quantification (POP-Q)
Time Frame
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Title
Bladder and bowel function, Prolapse symptoms, Sexuality
Description
Assessed via Pelvic Function Questionnaire
Time Frame
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Title
Quality of Life
Description
EQ-5D-5L questionnaire
Time Frame
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Title
Patient satisfaction after surgery
Time Frame
At follow up 6 weeks, 6 months and 12 months after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Sarlos, MD
Phone
+41 838 5065
Email
dimitri.sarlos@ksa.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Ries, MD
Phone
+41 838 5995
Email
Jean-Jacques.Ries@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau (AG)
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
Phone
+41 62 838 5065
Email
dimitri.sarlos@ksa.ch
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Ries, MD
Phone
+41 62 838 5995
Email
Jean-Jacques.Ries@ksa.ch
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
First Name & Middle Initial & Last Name & Degree
Gabriel Schär, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22914470
Citation
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.
Results Reference
background
PubMed Identifier
19935030
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):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
Results Reference
background
PubMed Identifier
23298608
Citation
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.
Results Reference
background
PubMed Identifier
16319998
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. doi: 10.1007/s00192-005-0019-0. Epub 2005 Nov 30.
Results Reference
background
PubMed Identifier
20002370
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.
Results Reference
background
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Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study
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