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

Kantonsspital Aarau1 site in 1 country100 target enrollmentJanuary 2015

ConditionsUterus Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Uterus Prolapse
Sponsor: Kantonsspital Aarau
Enrollment: 100
Locations: 1
Primary Endpoint: Operation time
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

October 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Kantonsspital Aarau

Responsible Party

Principal Investigator

Dimitri Sarlos

Chair Department of Gynecology

Kantonsspital Aarau

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

Outcomes

Primary Outcomes

Operation time

Time Frame: expected average of 150 minutes

Comparison of operation time in the 2 arms of the study

Secondary Outcomes

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)
Quality of Life(8 weeks before surgical intervention and at follow up 6 weeks, 6 months and 12 months after intervention)
Patient satisfaction after surgery(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)