Main objective is to determine whether patients have a better recovery after laparoscopic sterilization or a diagnostic laparoscopy under conscious sedation compared to general anesthesia as measured with the QoR-40 one day after surgery.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome measure is total patients* recovery as measured with the Quality
of Recovery 40 questionnaire (QoR-40) one day after surgery.
Secondary outcome
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).
Background summary
Laparoscopic sterilization or a diagnostic laparoscopy are common minimally
invasive procedures. A recently published systematic review shows that
patients* might benefit from a laparoscopic procedure using conscious sedation
compared to general anesthesia. However, only few and relatively old studies
could be included, pointing out the importance of new research regarding this
subject.
Study objective
Main objective is to determine whether patients have a better recovery after
laparoscopic sterilization or a diagnostic laparoscopy under conscious sedation
compared to general anesthesia as measured with the QoR-40 one day after
surgery.
Study design
Randomized Controlled Trial
Intervention
The control group will undergo sterilization or a diagnostic laparoscopy under
general anesthesia; the intervention group will receive conscious sedation
using Propofol and Fentanyl.
Study burden and risks
In this study with capacitated adults no additional risks are expected compared
to patients who undergo a laparoscopic sterilisation or a diagnostic
laparoscopy without participating in the study. Patients* burden of completing
questionnaires about their health and recovery both before and after surgery is
in proportion to the potential value of our research.
Michaelangelolaan 2
Eindhoven 5623 EJ
NL
Michaelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Wish for female sterilization with Filshie clips or indication for diagnostic
laparoscopy
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68039.100.18 |
| Other | NTR-7092 |