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


Since 2009, the UOC Chirurgia Pediatrica (Pediatric Surgery Unit)  has started to adopt minimally invasive techniques for various surgical diseases in children. These innovative techniques have been embarked under strict guidelines and with the intent to explore the real benefits in such restricted population. This is the only centre in Rome which has tried to use these techniques also in neonates.
In this process, a close collaboration with the Institute of Child Health - University College of London - and the Great Ormond Street Hospital for Sick Children of London has been established. These institutions are worldwide leading centres in the field of minimally invasive surgery in neonates and children. 

Minimally invasive surgery (MIS) is now widely used in infants and children. During this type of surgery, a working space is created in the abdomen or thorax by "inflating" with carbon dioxide (CO2). Some of this CO2 is absorbed, and in adults or infants and children undergoing abdominal or chest surgery, this additional CO2 can be eliminated by the anaesthetist by increasing the ventilation rate. However, occasionally the CO2 level in the blood may raise leading to acidosis and possible deleterious consequences for the heart and the brain.
It is not known whether the potential for greater CO2 absorption in neonates, infants and children undergoing minimally invasive surgery, given their cardiovascular, pulmonary, and thermoregulatory specificities, does in fact lead to problems. The aim of this pilot study is to compare brain and splanchnic oxygenation, CO2 levels, urinary output and surgical outcomes during (i) open surgery and (ii) minimally invasive surgery in either neonates, infants and children.
The advent of this new surgical procedure in such young children, nevertheless requires a thorough evaluation of its tolerance.

A prospective cohort study will be conducted in neonates, infants and children who will undergo MIS (study group) and open surgery (control group) at the Pediatric Surgery Unit, Policlinico Umberto I, Rome, Italy.
The main factors influencing the results are (i) age at operation, (ii) duration of surgery (iii) surgical approach (MIS or open surgery). The selection between MIS and open surgery will be determined by the operating surgeon’s preference. The study groups will consist of patient undergoing general surgery and urology operations either by MIS approach or open surgery. Both intraoperative and postoperative complications and the learning curve will be evaluate for both MIS and open surgery (performed by trainees, young pediatric surgeons, senior pediatric surgeons).
Before, during and after surgery, infants will undergo the following measurements:

(i)    oxygenation of the brain will be measured continuously via a non-invasive technique called near-infra red spectroscopy. This involves placing a probe on the head.
(ii)     blood samples will be taken for measurement of blood gases during the operation.
(iii)    breath samples will be taken every 15 minutes to measure the proportion of carbon dioxide that originates from the carbon dioxide that is used to inflate the chest or the abdomen. We will measure the breath 13CO2/12CO2 natural abundance using isotope ratio mass spectrometry in these neonates undergoing surgery.
(iv)    Urine output.
(v)    Electrolytes, Creatinine and Urea.

This project received a grant from the Nando Peretti Foundation.

The aim is to achieve the following research objectives at different age in neonates, infants and children undergoing MIS or open surgery:
1. to determine differences between oxygenation of the brain (measured by a non-invasive technique, near infra-red spectroscopy).
2.  to compare the changes in blood gases
3.  to measure the urine output
4. to measure absorption of exogenous carbon dioxide in expired breath using a isotope-ratio mass spectrometry method
5. to establish the metabolic and thermal effects of MIS
6. to evaluate surgical outcomes and the learning curve for both approaches when performed by a trainee, young pediatric surgeon or a senior pediatric surgeon.

think global, act local
you are here: Home  > Projects:  Medical research or Europe  (or Both)  > 2013-027  > Project Description