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.

Abstract

Objective: To report one-year morbidity of robotic-assisted laparoscopic surgery (RALS) in a dedicated, multidisciplinary, pediatric robotic surgery program. Summary Background Data. RALS in pediatric surgery is expanding, but data on morbidity in children is limited.

Methods: All children who underwent RALS (Da Vinci Xi, Intuitive Surgical, USA) were prospectively included (October 2016 to May 2020; follow-up ≥1 year). Analyzed data: patient characteristics, surgical indication/procedure, intraoperative adverse events (ClassIntra classification), blood transfusion, hospital stay, postoperative complications (Clavien-Dindo).

Results: Three hundred consecutive surgeries were included: urology/gynecology (n=105), digestive surgery (n=83), oncology (n=66), ENT surgery (n=28), thoracic surgery (n=18). Median age and weight at surgery were 9.5 [interquartile range (IQR)=8.8] years and 31 [IQR=29.3] kg, respectively. Over one year, 65 (22%) children presented with ≥1 complication, with Clavien-Dindo ≥III in 14/300 (5%) children at ≤30 days, 7/300 (2%) at 30-90 days, and 12/300 (4%) at >90 days. Perioperative transfusion was necessary in 15 (5%) children, mostly oncological (n=8). Eight (3%) robotic malfunctions were noted, one leading to conversion (laparotomy). Overall conversion rate was 4%. ASA ≥3, weight ≤15 kg, and surgical oncology did not significantly increase the conversion rate, complications, or intraoperative adverse events (ClassIntra ≥2). ASA score was significantly higher in children with complications (Clavien-Dindo ≥III) than without (p=0.01). Median hospital stay was 2 [IQR=3] days. Three children died after a median follow-up of 20 [IQR=16] months.

Conclusions: RALS is safe, even in the most vulnerable children with a wide scope of indications, age, and weight. Robot-specific complications or malfunctions are scarce.

Trial registration: ClinicalTrials.gov NCT03274050.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Humans
  • Laparoscopy* / methods
  • Morbidity
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology
  • Prospective Studies
  • Retrospective Studies
  • Robotic Surgical Procedures* / adverse effects
  • Robotic Surgical Procedures* / methods
  • Robotics* / methods
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03274050