Laparoscopic sterilization and diagnostic laparoscopy under general anesthesia or conscious sedation; a randomized controlled trial

Laparoscopic sterilization and diagnostic laparoscopy under general anesthesia or conscious sedation; a randomized controlled trial - Laparoscopic procedures under general anesthesia or conscious sedation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56040

Enrollment

Registered

2019-10-25

Start date

2021-06-16

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

diagnostic laparoscopy Female sterilization

Interventions

The control group will undergo sterilization or a diagnostic laparoscopy under general anesthesia

the intervention group will receive conscious sedation using Propofol and Fentanyl.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Wish for female sterilization with Filshie clips or indication for diagnostic laparoscopy

Exclusion criteria

Exclusion criteria: - Being younger than 18 years old - Not understanding the Dutch language - ASA classification 3 or 4 and therefore not being eligible for conscious sedation in our clinic - Extensive abdominal surgery in the past which high chance of adhesions

Design outcomes

Primary

Measure	Time frame
Main outcome measure is total patients* recovery as measured with the Quality of Recovery 40 questionnaire (QoR-40) one day after surgery.	—

Secondary

Measure	Time frame
Secondary outcome measures are the number of complications, operating times, recovery times, peri-operative parameters such as heart rate, blood pressure and saturation, and late patients* recovery as measured with the Recovery Index-10 (RI-10).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)