aparoscopically assisted vaginal hysterectomy (LAVH) versus vaginal hysterectomy (VH) -a prospective, randomized, double-blind study in patients with an indication for vaginal hysterectomy

Not Applicable

• Conditions: OPS-2015 5-683.02 (Laparoscopic assisted vaginal hysterectomy); N94; Pain and other conditions associated with female genital organs and menstrual cycle

• Registration Number: DRKS00009356
• Lead Sponsor: niversitätsfrauenklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-09-13
• Study Start: 2015-10-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

• removal of the uterus possible via the vaginal route
• circulatory disorders (hypermenorrhea, dysmenorrhea)
• Uterine fibroids
• adenomyosis
• uterine descent et vaginae with and without voiding dysfunction
• cervical cancer stage pT1a1
• Age> 18 years

Exclusion Criteria

lack of study consent
• indication for vaginal hysterectomy after Sacrocolpopexy
• indication for lateral repair in lateral defect
• Malignancies with the indication for abdominal procedure
• Pre-existing conditions (internal medicine / orthopedic / anestesiologic) contraindicate the laparoscopic approach
• with continuous motion opioids in the last 12 months more than 2 weeks
• Metamizol- / Dipidolorallergie
• severe mental / neurological disorders
• alcohol, drugs, drug for pain-missuse
• polyneuropathy
• Immunosuppressive therapy
• participating in other studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain with and without open peritoneum<br><br>Postoperatively to discharge the pain medication consumption and morning, noon and evening pain intensity will be daily documented using the Visual Analog Scale.<br><br>This will be performed 6 weeks, six months and one year postoperatively by the patient.

Secondary Outcome Measures

Name	Time	Method
postoperative mobility<br>- Daily survey of both the patient as well as by a blinded observer (not attending physician of the clinic, nurse or physiotherapist) with a mobility questionnaire<br> <br>This will be performed 6 weeks, six months and one year postoperatively by the patient.<br><br>Additional Safety parameters:<br>intraoperative blood loss and the type and frequency of complications