SurgeryPECRoPNCT03274050
To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults
An observational study of Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical procedures in adult patients across a broad spectrum of surgical specialties. This has occurred despite the high costs and uncertain benefits of surgical robots. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- How many people
- 16,000 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2018to Aug 2029
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients operated in surgery department participating of the study with indication of robot in the routine care (all specialities)
Who may be able to join
- child or adult
- with an indication for a robotic surgery
- non-opposition of patient or non-opposition of parents for minor patient
Who cannot join
- anatomic or anesthetic contraindication for the mini-invasive surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker -Enfants Malades
Paris, Paris, 75015
Thomas Blanc, MD, PhD, 01 44 49 41 53, thomas.blanc@aphp.fr
About this study
Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical procedures in adult patients across a broad spectrum of surgical specialties. This has occurred despite the high costs and uncertain benefits of surgical robots.
In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to embrace the surgical robot. Many children's hospitals do not even possess a surgical robot, and many of those that do borrow them from the adult operating room within the same medical facility.
Read more
Since the first case of robotic minimally invasive surgery in children in 2000, robotic procedures have been slowly adopted by select pediatric surgical specialists.
Advocates of robotic minimally invasive surgical systems add many useful features that include improved dexterity, motion scaling, tremor filtration, greater optical magnification (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic instruments used in robotic surgery provide seven degrees of freedom.
For the surgeon, these features may allow for more precise dissection with increased magnification and visibility. The intuitive controls of the robot are purported as providing the ability to perform laparoscopic procedures in an "open" fashion. In pediatric surgical procedures, these technical abilities may have the potential to surpass the physical capabilities of human performance in the tight operative fields encountered in children.
This study aims to evaluate the clinical safety, effectiveness, and cost-effectiveness of robot-assisted minimally invasive surgery in both pediatric and adult patients. Robotic surgery was developed to overcome key limitations of conventional laparoscopy, including 2D visualization, limited instrument mobility, poor ergonomics, and long learning curves. The trial will assess clinical outcomes, postoperative pain, length of stay, return to daily activities, access to minimally invasive surgery, and the impact of robotic surgery on surgical training. Specific indications, such as pyeloplasty, will also be compared with open and conventional laparoscopic approaches.
Read the detailed description
Minimally invasive surgery (MIS) has transformed surgical practice since the 1980s, offering reduced postoperative pain, shorter hospitalization, faster recovery, and improved cosmetic outcomes. However, conventional laparoscopy is limited by rigid instruments, 2D imaging, non-intuitive motion, and challenging ergonomics, resulting in long learning curves, especially in pediatric surgery where operative spaces are smaller.
Robot-assisted surgery, introduced in 1999 with the Da Vinci system, was designed to overcome these limitations by providing 3D high-definition visualization, articulated instruments with seven degrees of freedom, tremor filtration, intuitive movements, surgeon-controlled camera operation, and improved ergonomics. Its dual-console configuration also enhances surgical training.
Despite widespread adoption in adults, pediatric use remains limited. This multicenter study will evaluate robot-assisted surgery across several specialties (urology, gynecology, visceral surgery, thoracic surgery, pediatric surgery, and ENT), in accordance with CE-marked indications.
The study will assess:
clinical outcomes and quality of life, postoperative pain, length of stay, and return to daily activities, access to MIS for patients with comorbidities or complex multidisciplinary needs, reduction of the learning curve compared with laparoscopy, benefits for resident and fellow training, and, for pyeloplasty, comparison with open and laparoscopic techniques. Interim analyses will be performed and may generate hypotheses for future research.
- Conditions
- Surgery
- Keywords
- robot, surgery, pediatry (0-20 years included), adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities). | |
| control group | Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per and post-surgery complication
per and post-surgery complication (Clavien-Dindo score)
Measured: 6 months
Secondary outcomes (22)
Post-surgery pain with analgesic prescription
Measured: 6 months
Resection quality (R0) of oncologic surgery
Measured: 6 months
Functional results according to the surgery indication
Measured: 6 months
Quality of life (SF-36)
36-items Short Form health survey
Measured: At the inclusion visit (baseline) and 6 months
Health survey (EQ-5D-5L)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5)
Measured: At the inclusion visit (baseline) and 6 months
The Saint-George's hospital Respiratory Questionnaire (SGRQ)
0 indicates best health and 100 indicates worst health
Measured: At the inclusion visit (baseline) and 6 months
Patient Global Impression of Improvement (PGI-I)
1-question assessment designed to evaluate the patient's impression of improvement since surgery- PGI-I score: 1 = very much better; 2 = much better; 3 = a little better; 4 = no change; 5 = a little worse; 6 = much worse; 7 = very much worse
Measured: At the inclusion visit (baseline) and 6 months
Female Sexual Function Index (FSFI)
The FSFI is a validated 19-item self-administered questionnaire assessing female sexual function across six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) during the previous 4 weeks. Domain scores are weighted according to the FSFI scoring algorithm and summed to generate a total score ranging from 2 to 36, with higher scores indicating better sexual function.
Measured: At the inclusion visit (baseline) and 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
The PISQ-12 is a validated, disease-specific, self-administered questionnaire designed to assess sexual function in women with pelvic organ prolapse and/or urinary incontinence. The questionnaire consists of 12 items evaluating three domains: behavioral-emotive aspects, physical factors, and partner-related factors affecting sexual function. Responses are summed to generate a total score, with higher scores indicating better sexual function.
Measured: At the inclusion visit (baseline) and 6 months
Frequency and percentage of intervention with robot in each speciality
Measured: 6 months
Duration of activity of the operating block
Measured: 6 months
Average duration of anaesthesia
Measured: 6 months
Average duration of robotic surgery and docking
Measured: 6 months
Duration of intervention by speciality (learning curve)
Measured: 6 months
Frequency and percentage of conversion to open-procedure
Measured: 6 months
Post surgery pain (Evendol pain scale)
Measured: 6 months
Prescription of analgesic
Measured: 6 months
Duration of hospitalization
Measured: 6 months
Cost of robotic surgery by indication, tools and supplies
Measured: 6 months
Duration of post surgery work stoppage (activ patient)
Measured: 6 months
Duration before returning to normal activity (other patient)
Measured: 6 months
Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start28 Feb 2018
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Thomas BLANC, MD; PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisMorgane ROUPRET, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274050
- Sponsor's protocol ID
- NI16026J
- Other IDs
- 2017-A01507-46
- Acronym
- PECRoP
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2017
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franzini S, Querciagrossa S, Brebion M, Consonni D, Blanc T, Orliaguet G. Effect of retropneumoperitoneum on cerebral and renal oxygen saturation during retroperitoneal robotic-assisted laparoscopic pyeloplasty (R-RALP) in a pediatric population: Preliminary results of a prospective observational study using a dedicated anesthetic protocol and Near-InfraRed Spectroscopy. Anaesth Crit Care Pain Med. 2023 Oct;42(5):101234. doi: 10.1016/j.accpm.2023.101234. Epub 2023 Apr 28.
PubMed 37121359Vinit N, Vatta F, Broch A, Hidalgo M, Kohaut J, Querciagrossa S, Couloigner V, Khen-Dunlop N, Botto N, Capito C, Sarnacki S, Blanc T. Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study. Ann Surg. 2023 Nov 1;278(5):e932-e938. doi: 10.1097/SLA.0000000000005808. Epub 2023 Jan 23.
PubMed 36692109Harte C, Ren M, Querciagrossa S, Druot E, Vatta F, Sarnacki S, Dahmani S, Orliaguet G, Blanc T. Anaesthesia management during paediatric robotic surgery: preliminary results from a single centre multidisciplinary experience. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100837. doi: 10.1016/j.accpm.2021.100837. Epub 2021 Mar 20.
PubMed 33757915
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults
- ClinicalTrials.gov ID
- NCT03274050
- Acronym / sponsor ID
- PECRoP / NI16026J
- Conditions
- Surgery
- Keywords
- robot, surgery, pediatry (0-20 years included), adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Intuitive Surgical, URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 Sep 2017 (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.
Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical procedures in adult patients across a broad spectrum of surgical specialties. This has occurred despite the high costs and uncertain benefits of surgical robots.
In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to embrace the surgical robot. Many children's hospitals do not even possess a surgical robot, and many of those that do borrow them from the adult operating room within the same medical facility.
Since the first case of robotic minimally invasive surgery in children in 2000, robotic procedures have been slowly adopted by select pediatric surgical specialists.
Advocates of robotic minimally invasive surgical systems add many useful features that include improved dexterity, motion scaling, tremor filtration, greater optical magnification (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic instruments used in robotic surgery provide seven degrees of freedom.
For the surgeon, these features may allow for more precise dissection with increased magnification and visibility. The intuitive controls of the robot are purported as providing the ability to perform laparoscopic procedures in an "open" fashion. In pediatric surgical procedures, these technical abilities may have the potential to surpass the physical capabilities of human performance in the tight operative fields encountered in children.
This study aims to evaluate the clinical safety, effectiveness, and cost-effectiveness of robot-assisted minimally invasive surgery in both pediatric and adult patients. Robotic surgery was developed to overcome key limitations of conventional laparoscopy, including 2D visualization, limited instrument mobility, poor ergonomics, and long learning curves. The trial will assess clinical outcomes, postoperative pain, length of stay, return to daily activities, access to minimally invasive surgery, and the impact of robotic surgery on surgical training. Specific indications, such as pyeloplasty, will also be compared with open and conventional laparoscopic approaches.
Detailed description
Minimally invasive surgery (MIS) has transformed surgical practice since the 1980s, offering reduced postoperative pain, shorter hospitalization, faster recovery, and improved cosmetic outcomes. However, conventional laparoscopy is limited by rigid instruments, 2D imaging, non-intuitive motion, and challenging ergonomics, resulting in long learning curves, especially in pediatric surgery where operative spaces are smaller.
Robot-assisted surgery, introduced in 1999 with the Da Vinci system, was designed to overcome these limitations by providing 3D high-definition visualization, articulated instruments with seven degrees of freedom, tremor filtration, intuitive movements, surgeon-controlled camera operation, and improved ergonomics. Its dual-console configuration also enhances surgical training.
Despite widespread adoption in adults, pediatric use remains limited. This multicenter study will evaluate robot-assisted surgery across several specialties (urology, gynecology, visceral surgery, thoracic surgery, pediatric surgery, and ENT), in accordance with CE-marked indications.
The study will assess:
clinical outcomes and quality of life, postoperative pain, length of stay, and return to daily activities, access to MIS for patients with comorbidities or complex multidisciplinary needs, reduction of the learning curve compared with laparoscopy, benefits for resident and fellow training, and, for pyeloplasty, comparison with open and laparoscopic techniques. Interim analyses will be performed and may generate hypotheses for future research.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | –Surgery with robot - all patients operated in surgery department with indication of robot in the routine care (all specialities). |
| control group | – | –Retroperitoneal coelioscopy - patient operated for pyeloplasty - only for pediatry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients operated in surgery department participating of the study with indication of robot in the routine care (all specialities)
Key inclusion criteria (3 listed)
- child or adult
- with an indication for a robotic surgery
- non-opposition of patient or non-opposition of parents for minor patient
Key exclusion criteria (1 listed)
- anatomic or anesthetic contraindication for the mini-invasive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Per and post-surgery complication
Time frame: 6 months
per and post-surgery complication (Clavien-Dindo score)
22 secondary outcomes
Post-surgery pain with analgesic prescription
Time frame: 6 months
Resection quality (R0) of oncologic surgery
Time frame: 6 months
Functional results according to the surgery indication
Time frame: 6 months
Quality of life (SF-36)
Time frame: At the inclusion visit (baseline) and 6 months
Health survey (EQ-5D-5L)
Time frame: At the inclusion visit (baseline) and 6 months
The Saint-George's hospital Respiratory Questionnaire (SGRQ)
Time frame: At the inclusion visit (baseline) and 6 months
Patient Global Impression of Improvement (PGI-I)
Time frame: At the inclusion visit (baseline) and 6 months
Female Sexual Function Index (FSFI)
Time frame: At the inclusion visit (baseline) and 6 months
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)
Time frame: At the inclusion visit (baseline) and 6 months
Frequency and percentage of intervention with robot in each speciality
Time frame: 6 months
Duration of activity of the operating block
Time frame: 6 months
Average duration of anaesthesia
Time frame: 6 months
Average duration of robotic surgery and docking
Time frame: 6 months
Duration of intervention by speciality (learning curve)
Time frame: 6 months
Frequency and percentage of conversion to open-procedure
Time frame: 6 months
Post surgery pain (Evendol pain scale)
Time frame: 6 months
Prescription of analgesic
Time frame: 6 months
Duration of hospitalization
Time frame: 6 months
Cost of robotic surgery by indication, tools and supplies
Time frame: 6 months
Duration of post surgery work stoppage (activ patient)
Time frame: 6 months
Duration before returning to normal activity (other patient)
Time frame: 6 months
Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale
Time frame: 6 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 10 Aug 2026.
- Derived from this study: PubMed 37121359Franzini S, Querciagrossa S, Brebion M, Consonni D, Blanc T, Orliaguet G. Effect of retropneumoperitoneum on cerebral and renal oxygen saturation during retroperitoneal robotic-assisted laparoscopic pyeloplasty (R-RALP) in a pediatric population: Preliminary results of a prospective observational study using a dedicated anesthetic protocol and Near-InfraRed Spectroscopy. Anaesth Crit Care Pain Med. 2023 Oct;42(5):101234. doi: 10.1016/j.accpm.2023.101234. Epub 2023 Apr 28.
- Derived from this study: PubMed 36692109Vinit N, Vatta F, Broch A, Hidalgo M, Kohaut J, Querciagrossa S, Couloigner V, Khen-Dunlop N, Botto N, Capito C, Sarnacki S, Blanc T. Adverse Events and Morbidity in a Multidisciplinary Pediatric Robotic Surgery Program. A prospective, Observational Study. Ann Surg. 2023 Nov 1;278(5):e932-e938. doi: 10.1097/SLA.0000000000005808. Epub 2023 Jan 23.
- Derived from this study: PubMed 33757915Harte C, Ren M, Querciagrossa S, Druot E, Vatta F, Sarnacki S, Dahmani S, Orliaguet G, Blanc T. Anaesthesia management during paediatric robotic surgery: preliminary results from a single centre multidisciplinary experience. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100837. doi: 10.1016/j.accpm.2021.100837. Epub 2021 Mar 20.
- Individual participant dataSharing planned: No
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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.
Thomas BLANC, MD; PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Morgane ROUPRET, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 1 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 10 Aug 2026. 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 France. 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 Thomas BLANC, MD, PhD (01 44 49 41 53, thomas.blanc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per and post-surgery complication (time frame: 6 months). 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 NCT03274050, which also lists 3 linked publications.
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 10 Aug 2026.