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NCT Number: NCT03274050

To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker -Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Thomas Blanc, MD, PhD

CONTACT

[email protected]

01 44 49 41 53

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • child or adult
  • with an indication for a robotic surgery
  • non-opposition of patient or non-opposition of parents for minor patient

Exclusion criteria

  • anatomic or anesthetic contraindication for the mini-invasive surgery

Treatment and study plan

Primary outcomes

  1. Per and post-surgery complication

    Time frame: 6 months

    per and post-surgery complication (Clavien-Dindo score)

Secondary outcomes

  1. Post-surgery pain with analgesic prescription

    Time frame: 6 months

  2. Resection quality (R0) of oncologic surgery

    Time frame: 6 months

  3. Functional results according to the surgery indication

    Time frame: 6 months

  4. Quality of life (SF-36)

    Time frame: At the inclusion visit (baseline) and 6 months

    36-items Short Form health survey

  5. Health survey (EQ-5D-5L)

    Time frame: At the inclusion visit (baseline) and 6 months

    Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5)

  6. The Saint-George's hospital Respiratory Questionnaire (SGRQ)

    Time frame: At the inclusion visit (baseline) and 6 months

    0 indicates best health and 100 indicates worst health

  7. Patient Global Impression of Improvement (PGI-I)

    Time frame: At the inclusion visit (baseline) and 6 months

    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

  8. Female Sexual Function Index (FSFI)

    Time frame: At the inclusion visit (baseline) and 6 months

    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.

  9. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)

    Time frame: At the inclusion visit (baseline) and 6 months

    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.

  10. Frequency and percentage of intervention with robot in each speciality

    Time frame: 6 months

  11. Duration of activity of the operating block

    Time frame: 6 months

  12. Average duration of anaesthesia

    Time frame: 6 months

  13. Average duration of robotic surgery and docking

    Time frame: 6 months

  14. Duration of intervention by speciality (learning curve)

    Time frame: 6 months

  15. Frequency and percentage of conversion to open-procedure

    Time frame: 6 months

  16. Post surgery pain (Evendol pain scale)

    Time frame: 6 months

  17. Prescription of analgesic

    Time frame: 6 months

  18. Duration of hospitalization

    Time frame: 6 months

  19. Cost of robotic surgery by indication, tools and supplies

    Time frame: 6 months

  20. Duration of post surgery work stoppage (activ patient)

    Time frame: 6 months

  21. Duration before returning to normal activity (other patient)

    Time frame: 6 months

  22. Difference in average costs per patients (in €) divided by the difference in post operative complications using the Clavien Dindo scale

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah BOUCHARD

CONTACT

[email protected]

01 42 19 28 79

Thomas BLANC, MD, PhD

CONTACT

[email protected]

01 44 49 41 53

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Intuitive Surgical
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: PECRoP

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Sep 6, 2017
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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