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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
Kantonsspital Aarau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterus Prolapse focused on measuring Uterus Prolapse, Laparoscopic Sacropexy, Laparoscopic Hysteropexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 21, 2014
Last Updated
September 1, 2020
Sponsor
Kantonsspital Aarau
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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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