Health TrialsbyHealthPanel

Robotic Versus Laparoscopic Surgery for Deep Endometriosis

ConditionsEndometriosisDeep EndometriosisSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Oulu

About this trial

The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA (American Society of Anesthesiologists physical status classification) 1-3

Diagnosed deep endometriosis (MRI)

Patient has symptoms

Operative treatment is indicated

Disqualifiers

ASA > 3

Recurring rectosigmoid endometriosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally invasive surgery

    Procedure/Surgery

    Minimally invasive surgery for severe deep endometriosis

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Robot-assisted laparoscopyExperimental treatment 1 intervention
Group B: Conventional laparoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

NRS (Numeric rating scale) Score for pain

The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.

Time frame
Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively

Secondary outcomes

1

Intraoperative measures

Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.

Time frame
Up to 300 minutes (intraoperative)
2

Factors concerning ERAS (Enhanced recovery after surgery)

Nausea (yes/no), vomiting (yes/no), peroral intake (minutes from surgery), mobilization (minutes from surgery), bowel movement (minutes from surgery), time of discharge (hours after surgery), complications (classified according to Clavien-Dindo) for both study groups.

Time frame
Up to 7 days (Hospital stay)
3

Cost

Cost, euros.

Time frame
Primary hospital stay and 24 months, for both study groups.
4

Complications

Complications (classified according to Clavien-Dindo), readmissions to hospital.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oulu

Lead sponsor

Source ClinicalTrials.gov
Apply now