vNOTES surgery compared to conventional laparoscopy surgery through vagina or abdominal wall endoscopically
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: participant is willing en able te give infomed consent for participation in the trialfemale aged 18 years and abovediagnosed with adnexal pathology or subject for prophylactic BSO (bilateral salpingo-oophorectomy)
Exclusion criteria
Exclusion criteria: female participant who is pregnant or planning pregnancy during course of the trialscheduled elective surgery or other procedures requiring general anaesthesia during the trialany other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial. or may influence the result of the trial, or the participant's ability to participate in the trialpatients taking opioids or other painkillers routinely pre-operativelypatients with chronic pelvic painpatients with surgical contraindications: previous hysterectomy, history of rectal surgery, suspected or confirmed endometriosis, suspected malignancy, suspected obliteration of the pouch of Douglas following severe PID or othes causes, active lover genital tract infection, pregnancy.failure to provide written informed consent prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain: VAS score | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain- Conversion, perioperative complications, surgical time- Postoperative complications- Readmission- Surgeon’s experience of comfort and flow | — |
Countries
Belgium, Croatia, Italy, Netherlands, Sweden
Contacts
Zuyderland