Hysteropexy in treatment of uterine prolapse stage >= 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy (LAVA-trial)

Completed

• Conditions: prolapse; uterine descent; 10046828

• Registration Number: NL-OMON40293
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

Uterine descent POP-Q stage >= 2 requiring surgery. Patients with co-existing anterior/posterior defects or concomitant incontinence surgery (TVT-O) can be included.

Exclusion Criteria

Previous pelvic floor or prolapse surgery
Wish to preserve fertility
Known malignancy or abnormal cervical smears
Unwilling to return for follow-up or language barriers
Presence of immunological/haematological disorders interfering with recovery after surgery
Contraindications for laparoscopic surgery (ileus, risk of severe adhesions)
Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Anatomical outcome and recurrence rate assessed by the POP-Q test at 1 and 5<br /><br>years follow-up. Recurrence rate is defined as uterine prolapse >= 2 with<br /><br>symptoms. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Subjective improvement on urogenital symptoms and quality of life (assessed by<br /><br>disease-specific and quality of life questionnaires), complications following<br /><br>surgery, hospital stay, post-operative recovery and sexual functioning,<br /><br>costs-effectiveness. </p><br>