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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009356
Enrollment
200
Registered
2015-10-14
Start date
2007-08-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OPS-2015 5-683.02 (Laparoscopic assisted vaginal hysterectomy) N94

Interventions

Group 1: LAVH (laparoscopically assisted vaginal hysterectomy) arm: 1. Postoperative to discharge from hospital, the pain intensity using the Visual Analog Scale (VAS) is a day of pain medication and

Sponsors

Universitätsfrauenklinik
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
postoperative mobility - 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 This will be performed 6 weeks, six months and one year postoperatively by the patient. Additional Safety parameters: intraoperative blood loss and the type and frequency of complications

Countries

Germany

Contacts

Public ContactHolm Eggemann

Universitätsfrauenklinik

holm.eggemann@med.ovgu.de+49-391-67-17473

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026