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Robotic Versus Laparoscopic Surgery for Deep Endometriosis (ROBEndo)

Primary Purpose

Endometriosis, Deep Endometriosis, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Minimally invasive surgery
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis surgery, Deep endometriosis surgery, Robotic surgery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Ostrobothnia Hospital DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted laparoscopy

Conventional laparoscopy

Arm Description

Surgery for deep endometriosis using robot-assisted laparoscopy.

Surgery for deep endometriosis using conventional laparoscopy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative measures
Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
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.
Cost
Cost, euros.
Complications
Complications (classified according to Clavien-Dindo), readmissions to hospital.
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.
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.
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.

Full Information

First Posted
December 7, 2021
Last Updated
May 11, 2023
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT05179109
Brief Title
Robotic Versus Laparoscopic Surgery for Deep Endometriosis
Acronym
ROBEndo
Official Title
Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Deep Endometriosis, Surgery
Keywords
Endometriosis surgery, Deep endometriosis surgery, Robotic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted laparoscopy
Arm Type
Experimental
Arm Description
Surgery for deep endometriosis using robot-assisted laparoscopy.
Arm Title
Conventional laparoscopy
Arm Type
Active Comparator
Arm Description
Surgery for deep endometriosis using conventional laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive surgery
Intervention Description
Minimally invasive surgery for severe deep endometriosis
Primary Outcome Measure Information:
Title
NRS (Numeric rating scale) Score for pain
Description
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 Outcome Measure Information:
Title
Intraoperative measures
Description
Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
Time Frame
Up to 300 minutes (intraoperative)
Title
Factors concerning ERAS (Enhanced recovery after surgery)
Description
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)
Title
Cost
Description
Cost, euros.
Time Frame
Primary hospital stay and 24 months, for both study groups.
Title
Complications
Description
Complications (classified according to Clavien-Dindo), readmissions to hospital.
Time Frame
30 days
Title
Endometriosis-related quality-of-life
Description
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.
Time Frame
6, 12 and 24 months
Title
General 15 dimensional health-related quality-of-life questionnaire
Description
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.
Time Frame
6, 12 and 24 months
Title
Sexual quality-of-life questionnaire
Description
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.
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna M Terho, MD
Phone
+35883153603
Email
anna.terho@fimnet.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Sari Koivurova, MD, PhD
Phone
+35883153082
Email
sari.koivurova@fimnet.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sari Koivurova, MD, PhD
Organizational Affiliation
Oulu University Hospital, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Ostrobothnia Hospital District
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koivurova
Email
sari.koivurova@fimnet.fi

12. IPD Sharing Statement

Citations:
PubMed Identifier
35851028
Citation
Terho AM, Makela-Kaikkonen J, Ohtonen P, Uimari O, Puhto T, Rautio T, Koivurova S. Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial). BMJ Open. 2022 Jul 18;12(7):e063572. doi: 10.1136/bmjopen-2022-063572.
Results Reference
derived

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Robotic Versus Laparoscopic Surgery for Deep Endometriosis

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