EndometriosisROBEndoNCT05179109
Robotic Versus Laparoscopic Surgery for Deep Endometriosis
A study testing Minimally invasive surgery in people with Endometriosis and Deep Endometriosis, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Deep Endometriosis, Surgery
- What is being tested?
- Minimally invasive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- 3 Oct 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- ASA > 3
- Recurring rectosigmoid endometriosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Northern Ostrobothnia Hospital District
Oulu, 90220
Koivurova, sari.koivurova@fimnet.fi
About this study
Official title: Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.
Read the 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.
- Conditions
- Endometriosis, Deep Endometriosis, Surgery
- Being tested
- Minimally invasive surgery
- Keywords
- Endometriosis surgery, Deep endometriosis surgery, Robotic surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgeryProcedure or surgery
Minimally invasive surgery for severe deep endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted laparoscopy | Experimental | Surgery for deep endometriosis using robot-assisted laparoscopy. Receives: Procedure: Minimally invasive surgery |
| Conventional laparoscopy | Active comparator | Surgery for deep endometriosis using conventional laparoscopy. Receives: Procedure: Minimally invasive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
Secondary outcomes (7)
Intraoperative measures
Operation time (minutes), blood loss (ml), complications (classified according to Clavien-Dindo) for both study groups.
Measured: Up to 300 minutes (intraoperative)
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.
Measured: Up to 7 days (Hospital stay)
Cost
Cost, euros.
Measured: Primary hospital stay and 24 months, for both study groups.
Complications
Complications (classified according to Clavien-Dindo), readmissions to hospital.
Measured: 30 days
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.
Measured: 6, 12 and 24 months
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.
Measured: 6, 12 and 24 months
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.
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start3 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari Koivurova, University of Oulu
- Investigators
- Sari Koivurova, MD, PhD, Principal investigator, Oulu University Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179109
- Sponsor's protocol ID
- ROBtrial1
- Acronym
- ROBEndo
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35851028
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05179109
- Acronym / sponsor ID
- ROBEndo / ROBtrial1
- Conditions
- Endometriosis, Deep Endometriosis, Surgery
- Keywords
- Endometriosis surgery, Deep endometriosis surgery, Robotic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted laparoscopy | Experimental | Procedure: Minimally invasive surgerySurgery for deep endometriosis using robot-assisted laparoscopy. |
| Conventional laparoscopy | Active comparator | Procedure: Minimally invasive surgerySurgery for deep endometriosis using conventional laparoscopy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- ASA > 3
- Recurring rectosigmoid endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgeryMinimally invasive surgery for severe deep endometriosis | Procedure or surgery | Conventional laparoscopy, Robot-assisted laparoscopy |
Primary outcome
NRS (Numeric rating scale) Score for pain
Time frame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
The surgical outcome as regards to pain symptoms (NRS questionnaire), absolute scores and change from baseline for both study groups.
7 secondary outcomes
Intraoperative measures
Time frame: Up to 300 minutes (intraoperative)
Factors concerning ERAS (Enhanced recovery after surgery)
Time frame: Up to 7 days (Hospital stay)
Cost
Time frame: Primary hospital stay and 24 months, for both study groups.
Complications
Time frame: 30 days
Endometriosis-related quality-of-life
Time frame: 6, 12 and 24 months
General 15 dimensional health-related quality-of-life questionnaire
Time frame: 6, 12 and 24 months
Sexual quality-of-life questionnaire
Time frame: 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 35851028Terho 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.
Related trials for Endometriosis
RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Endometriosis
Active, not recruiting
Feasibility of a Mindfulness Intervention for Endometriosis Surgery
Endometriosis, Pain
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
RecruitingObservational study
Retinal Imaging for Systemic Inflammation in Endometriosis
Endometriosis
Active, not recruiting
Nutritional Intervention for Endometriosis
Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sari Koivurova, MD, PhD principal investigator
Oulu University Hospital, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgery in people with Endometriosis and Deep Endometriosis, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna M Terho, MD (+35883153603, anna.terho@fimnet.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (Numeric rating scale) Score for pain (time frame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.