Laparoscopic Supracervical Hysterectomy and Sacropexy Versus Hysteropexy Study (HysPex)

Kantonsspital Aarau

Status: Unknown

Conditions: Uterus Prolapse

Treatments: Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy; Procedure: Laparoscopic Hysteropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT02345954

lapSKPvslapHP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Supracervical Hysterectomy and Sacropexy

Experimental group

Description:

Laparoscopic Supracervical Hysterectomy and Sacropexy

Treatment:

Procedure: Laparoscopic Supracervical Hysterectomy and Sacropexy

Hysteropexy

Experimental group

Description:

Laparoscopic Hysteropexy

Treatment:

Procedure: Laparoscopic Hysteropexy