Surgical Research Study on the Effects of Minimally Invasive Surgery Versus Open Surgery in Neonates, Infants and Children

Project location: ITALY, Rome
Project start date: September 2013 - Project end date: August 2014
Project number: 2013-027
Beneficiary: Dipartimento di Pediatria e Neuropsichiatria Infantile, Sapienza Università di Roma

Time span for this Final Report: January 2014 - January 2015

The Nando Peretti Foundation provided financial support for a 1-year Clinical Research Fellowship attached to the Pediatric Surgery Unit - Department of Pediatrics - "Sapienza" University of Rome. The funded Clinical Research Fellowship mainly focused on the effects of both minimally invasive surgery and open surgery in neonates, infants and children. The Fellowship was awarded in open competition by the "Sapienza" University of Rome - Department of Pediatrics.

Summary of the study:
The aim of the study was to investigate whether carbon dioxide (CO2) insufflation in infants undergoing laparoscopy alters cerebral and abdominal oxygenation compared with open surgery. After appropriate ethical approval, the research team enrolled 50 infants <12 months of age, (22 general surgery or urology procedures via open approach, 28 laparoscopy). Regional cerebral oxygen saturation (cSO2) and splanchnic oxygen saturation (sSO2) were measured using near-infrared spectroscopy. In addition, the research team evaluated clinical parameters such as end-tidal carbon dioxide levels (ETCO2), heart rate, body temperature, mean arterial pressure (MAP) and urine output. We found that cSO2 fell following start of operation in both the open and MIS groups, but the fall was greater in the open group such that the cSO2 was significantly lower in the open group at 15 and 30 minutes (p<0.05). There were no differences in sSO2 at any time. CO2 absorption increased during MIS with a maximum 17.93% ± 15.25 of exhaled CO2 originating from the pneumoperitoneum. Urine output and MAP and were significantly lower within 4 hours after MIS.
The research team concluded that laparoscopy in infants affects cerebral regional oxygen saturation less than open surgery and both have only minor effects on splanchnic oxygenation. Additionally, pneumoperitoneum leads to oliguria during the first post-operative hours, which is a completely reversible phenomenon.
Therefore, the results of this study further support the safety of minimally invasive surgery in young children, which is a research field not yet fully explored. A full-length draft of the study has currently been submitted for consideration of publication to a peer-reviewed journal in the field of pediatric surgery.

ii) Other scientific contributions.

The Clinical Research Fellow had also the opportunity to participate to other ongoing research projects run by the same research team of the Pediatric Surgery Unit, Sapienza University of Rome.
Interim data of these studies were presented by the Clinical Research Fellow at the following prestigious national and international Congresses of Pediatric Surgery:

1. Fate of diaphragm adaptation following congenital diaphragmatic hernia repair. Presented at the 15th European Congress of Paediatric Surgery, European Paediatric Surgeons' Association, Dublin, 18-21 June 2014.
2. Sequential closure of gastroschisis with a sutureless adhesive custom silo. Presented at the 15th European Congress of Paediatric Surgery, European Paediatric Surgeons' Association, Dublin, 18-21 June 2014.
3. The Significance Of Renal Dysfunction Before Surgery In Children With Unilateral Renal Tumor. Presented at the 61st British Congress of Paediatric Surgery, British Paediatric Surgeons' Association, Edinburgh, 22-25 July 2014.
4. Chiusura sequenziale di gastroschisi con silos costruito con pellicola adesiva e senza suture. Presented at the 7° Congresso Nazionale Congiunto, Società Italiana di Chirurgia Pediatrica, Bologna, 6-7 Novembre 2014.
5. Il destino dell'adattamento del diaframma dopo riparazione di ernia diaframmatica congenita. Presented at the 7° Congresso Nazionale Congiunto, Società Italiana di Chirurgia Pediatrica, Bologna, 6-7 Novembre 2014.
6. Il ruolo della disfunzione renale prima dell'intervento nei bambini con tumore renale monolaterale. Presented at the 7° Congresso Nazionale Congiunto, Società Italiana di Chirurgia Pediatrica, Bologna, 6-7 Novembre 2014.
7. Mini-toracotomia ascellare per la riparazione di atresia esofagea con fistola tracheo-esofagea distale nell'era endoscopica. Presented at the 7° Congresso Nazionale Congiunto, Società Italiana di Chirurgia Pediatrica, Bologna, 6-7 Novembre 2014.
8. Risk factors for chronic kidney disease in children after surgery for unilateral renal tumor. Presented at the 46th Congress of International Society of Pediatric Oncology (SIOP), Toronto, 22-25 October 2014.
9. The significance of renal dysfunction before surgery in children with unilateral renal tumor. Presented at the 46th Congress of International Society of Pediatric Oncology (SIOP), Toronto, 22-25 October 2014.

Clinical activities accomplished by the Clinical Research Fellowship recipient.

During the period of the Fellowship, the designed fellow has also been involved in a busy clinical practice in general pediatric surgery and neonatal surgery, attached to the Pediatric Surgery Unit of the Policlinico Umberto I University Hospital of Rome.
Additionally, the Fellowship recipient participated to a Master's Degree course in Pediatric Minimally Invasive Surgery and eventually defended a thesis entitled "Congenital Diaphragmatic Eventration Repair during Childhood: Minimally Invasive Surgery versus Open Approach". The dissertation took place at the Alma Mater Studiorum University of Bologna, Italy, 9th December 2014 (see document #2).

In conclusion, The Nando Peretti Foundation gave a unique opportunity to an outstanding young pediatric surgeon to further develop surgical expertise and to build research programs, which promoted national and international collaborations aimed at improving patient-centered health care to children needing surgical treatment.

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