Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study

Not Applicable

• Conditions: Uterus Prolapse
• Interventions: Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy; Procedure: Laparoscopic Hysteropexy

• Registration Number: NCT02345954
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-21
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Primary Completion: 2022-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supracervical Hysterectomy and Sacropexy	Laparoscopic Supracervical Hysterectomy and Sacropexy	Laparoscopic Supracervical Hysterectomy and Sacropexy
Hysteropexy	Laparoscopic Hysteropexy	Laparoscopic Hysteropexy

Primary Outcome Measures

Name	Time	Method
Operation time	expected average of 150 minutes	Comparison of operation time in the 2 arms of the study

Secondary Outcome Measures

Name	Time	Method
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	EQ-5D-5L questionnaire
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	Assessed via Pelvic Function Questionnaire

Trial Locations

Locations (1)

Kantonsspital Aarau; 🇨🇭 Aarau, Aargau (AG), Switzerland