aparoscopic sterilization under general anesthesia or conscious sedation; a randomized controlled trial

Recruiting

• Conditions: Female sterilization; 10038612

• Registration Number: NL-OMON56040
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Wish for female sterilization with Filshie clips

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main outcome measure is total patients* recovery as measured with the Quality<br /><br>of Recovery 40 questionnaire (QoR-40) one day after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the number of complications, operating times,<br /><br>recovery times, peri-operative parameters such as heart rate, blood pressure<br /><br>and saturation, and late patients* recovery as measured with the Recovery<br /><br>Index-10 (RI-10).</p><br>