Robotic Versus Laparoscopic Surgery for Deep Endometriosis

Surgery Clinical Trial

— ROBEndo  

Official title:

Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179109
• Other study ID #: ROBtrial1
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: University of Oulu
• Contact: Anna M Terho, MD
• Phone: +35883153603
• Email: anna.terho[@]fimnet.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA (American Society of Anesthesiologists physical status classification) 1-3
• Diagnosed deep endometriosis (MRI)
• Patient has symptoms
• Operative treatment is indicated
• Patient is able to give informed consent

Exclusion Criteria:

• ASA > 3
• Recurring rectosigmoid endometriosis

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis
• Surgery

Intervention

Procedure:
• Minimally invasive surgery
Minimally invasive surgery for severe deep endometriosis

Locations

Country	Name	City	State
Finland	Northern Ostrobothnia Hospital District	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
Secondary	Intraoperative measures	Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.	Up to 300 minutes (intraoperative)
Secondary	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.	Up to 7 days (Hospital stay)
Secondary	Cost	Cost, euros.	Primary hospital stay and 24 months, for both study groups.
Secondary	Complications	Complications (classified according to Clavien-Dindo), readmissions to hospital.	30 days
Secondary	Endometriosis-related quality-of-life	Quality-of-life questionnaire (EHP-30, Endometriosis-related health profile) described as absolute scores and change from the baseline. Scale 0-100. Score 0 equals the best outcome and score 100 equals the worst outcome.	6, 12 and 24 months
Secondary	General 15 dimensional health-related quality-of-life questionnaire	Quality-of-life questionnaire (15D, general quality-of-life questionnaire) described as absolute scores and change from baseline for both study groups. Scale 0-1. Score 0 equals the worst outcome and score 1 equals the best outcome.	6, 12 and 24 months
Secondary	Sexual quality-of-life questionnaire	Quality-of-life (FSFI, female sexual function index) described as absolute scores and change from baseline for both study groups. Scale 2,0-36,0. Score 2,0 equals the worst outcome and score 36,0 equals the best outcome.	6, 12 and 24 months