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Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study (HysPex)

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ClinicalTrials.gov Identifier: NCT02345954
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dimitri Sarlos, Kantonsspital Aarau

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.


Condition or disease Intervention/treatment Phase
Uterus Prolapse Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy Procedure: Laparoscopic Hysteropexy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supracervical Hysterectomy and Sacropexy
Laparoscopic Supracervical Hysterectomy and Sacropexy
Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy
Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy

Experimental: Hysteropexy
Laparoscopic Hysteropexy
Procedure: Laparoscopic Hysteropexy
Laparoscopic hysteropexy




Primary Outcome Measures :
  1. Operation time [ Time Frame: expected average of 150 minutes ]
    Comparison of operation time in the 2 arms of the study


Secondary Outcome Measures :
  1. Intra- and postoperative complication rate [ Time Frame: 1 year ]
  2. Duration of anaesthesia [ Time Frame: expected average of 200 minutes ]
  3. 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 ]
  4. Bladder and bowel function, Prolapse symptoms, Sexuality [ Time Frame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention ]
    Assessed via Pelvic Function Questionnaire

  5. Quality of Life [ Time Frame: 8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention ]
    EQ-5D-5L questionnaire

  6. Patient satisfaction after surgery [ Time Frame: At follow up 6 weeks, 6 months and 12 months after intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345954


Contacts
Contact: Dimitri Sarlos, MD +41 838 5065 dimitri.sarlos@ksa.ch
Contact: Jean-Jacques Ries, MD +41 838 5995 Jean-Jacques.Ries@ksa.ch

Locations
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau (AG), Switzerland, 5001
Contact: Dimitri Sarlos, MD    +41 62 838 5065    dimitri.sarlos@ksa.ch   
Contact: Jean-Jacques Ries, MD    +41 62 838 5995    Jean-Jacques.Ries@ksa.ch   
Principal Investigator: Dimitri Sarlos, MD         
Sub-Investigator: Gabriel Schär, Prof.         
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau

Publications:
Responsible Party: Dimitri Sarlos, Chair Department of Gynecology, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT02345954     History of Changes
Other Study ID Numbers: lapSKPvslapHP
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Keywords provided by Dimitri Sarlos, Kantonsspital Aarau:
Uterus Prolapse
Laparoscopic Sacropexy
Laparoscopic Hysteropexy

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse