Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study (HysPex)

September 1, 2020 updated by: Dimitri Sarlos, Kantonsspital Aarau

Laparoscopic Supracervical Hysterectomy and Sacropexy Compared to Uterus Conserving Hysteropexy: a Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Aargau (AG)
      • Aarau, Aargau (AG), Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau
        • Principal Investigator:
          • Dimitri Sarlos, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gabriel Schär, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: expected average of 150 minutes
Comparison of operation time in the 2 arms of the study
expected average of 150 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and postoperative complication rate
Time Frame: 1 year
1 year
Duration of anaesthesia
Time Frame: expected average of 200 minutes
expected average of 200 minutes
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
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
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
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
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
8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention
Patient satisfaction after surgery
Time Frame: At follow up 6 weeks, 6 months and 12 months after intervention
At follow up 6 weeks, 6 months and 12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Aarau

Investigators

  • Study Chair: Dimitri Sarlos, MD, Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lapSKPvslapHP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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