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Prospective, randomised, controlled, double-blind study to investigate the postoperative pain course following LAVH – Comparison of the application of heated, humidified CO2 insufflation gas and standard CO2 insufflation gas to maintain the integrity of the pneumoperitoneum

Prospective, randomised, controlled, double-blind study to investigate the postoperative pain course following LAVH – Comparison of the application of heated, humidified CO2 insufflation gas and standard CO2 insufflation gas to maintain the integrity of the pneumoperitoneum

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00003853
Enrollment
88
Registered
2012-04-30
Start date
2012-04-29
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

Patients with benign uterine conditions which require laparoscopic assisted vaginal hysterectomy D25

Interventions

Group 1: laparoscopic gas conditioning system Group 2: standard laparoscopic gas (room temperature, not humidified) at laparoscopy

Sponsors

Pius-Hospital Oldenburg, Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years and over, Patient suffers from a benign metropathy, Patient has had at least one vaginal delivery, Sonographic estimation of uterus weight below 400g, Preoperative estimation of surgery time between 1-2 h, Patients must be able to give their consent and must understand the risks associated with a participation in the study

Exclusion criteria

Exclusion criteria: Preoperative estimation of uterus weight over 400g, Previous surgeries in the case history and resulting suspicion of existing extensive adhesions, Longitudinal laparotomy in the case history, Current oncological disease, Simultaneous chronic disease that requires the continuous intake of analgesics, Simultaneous participation in another clinical trial, Intake/Application of inadmissible concomitant medication/therapy

Design outcomes

Primary

MeasureTime frame
Postoperative pain development after 2, 4, 6, 24, 48 hours (data collection with VAS (Visual analogue scale))

Secondary

MeasureTime frame
Postoperative analgesic consumption, Body temperature prior to, during and after surgery, Length of time spent in the recovery room, Duration of inpatient stay

Countries

Germany

Contacts

Public ContactRudy Leon De Wilde

Pius-Hospital Oldenburg, Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie

gyn-sekretariat@pius-hospital.de0441 2291501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 5, 2026