Study of the Influence of Intraperitoneal Insufflation of Carbon Dioxide (CO2) by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- C reactive protein blood level
研究概览
简要总结
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.
This severe pathology of the newborn , often premature, requires urgent medical and surgical treatment in 25 to 50% of cases. The morbidity is high, both digestive and neurological. ECUN can lead to complications at short-term (death, intestinal stenosis) and at long-term (neuro-cognitive disorders). The challenge of preserving the neurological development is a major issue. It involves control of inflammation. This inflammation causes neurological lesions and is responsible for a disorder of the long-term neurocognitive development.
At Robert-Debré and Trousseau, the management of newborns with ECUN is focused on the control of this inflammation. A laparoscopy is performed first. The carbon dioxide (CO2) insufflated into the abdomen during a laparoscopy is thought to have an anti-inflammatory effect according to several experimental and clinical studies. A preliminary retrospective study at Robert-Debré showed a decrease in postoperative inflammation (decrease in C reactive protein at Day2 and Day 7 post-op) as well as a decrease in morbimortality (decrease in the rate of stoma and reoperation) in children who had a laparoscopic first operation compared to those who had a laparotomy alone. However, in many hospitals, laparotomy alone is currently the only surgical option.
This preliminary study may demonstrate that laparoscopy decreases early morbidity and mortality in children with ECUN through reduced inflammation, as reflected by postoperative C reactive protein.
详细描述
NECO2 is a pilot trial, evaluating the intermediate effectiveness to short/medium term of laparoscopy on the inflammatory reaction of premature newborns with complicated ECUN, requiring surgical treatment.
This is a multicenter randomized controlled trial in single blind, in two parallel arms, in ratio 1:1, of superiority.
This trial compares laparoscopy plus laparotomy versus laparotomy alone.
Children will be randomized into 2 groups:
- Laparoscopy + laparotomy group
- Laparotomy group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
At the end of the operation, two dressings will be placed on the child's abdomen to ensure the blindness of the health professionals performing the postoperative care and the parents.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborn (term of birth: <37 weeks of amenorrhea)
- •Diagnosis of ECUN by the surgeon (distension abdominal +/- rectal bleeding +/- green gastric residue, increased biological inflammatory syndrome, + pneumatosis on abdominal radiography)
- •Hospitalized and complicated ECUN: presenting either a pneumoperitoneum on abdominal X-ray or a absence of clinical and biological improvement after 48 hours of maximum well-conducted medical treatment (IV antibiotic therapy and digestive rest).
- •Hospitalized in the 2 participating centers
- •Of which the 2 holders of parental authority have been informed and have signed the consent form
- •Having social security coverage (social security or CMU)
排除标准
- •Instability contraindicating movement to the operating room or contraindicating CO2 insufflation
- •Diagnosis of isolated perforation of the small intestine (radiography:
- •pneumoperitoneum without pneumatosis)
结局指标
主要结局
C reactive protein blood level
时间窗: between Day 0 and Day 2 post surgery
C reactive protein blood level
次要结局
- Postoperative intestinal morbidity: stoma rate(up to 3 months)
- Postoperative intestinal morbidity: Duration of hemodynamic support(up to 3 months)
- Postoperative mortality(up to 3 months)
- Postoperative intestinal morbidity: Duration of parenteral nutrition(up to 3 months)
- Postoperative intestinal morbidity: Duration of invasive ventilation (HFO: High frequency oscillatory ventilation/VACI: Synchronized Intermittent Mandatory Ventilation)(up to 3 months)
- Postoperative reoperation rate(up to 3 months)
- Specific post-operative biological inflammatory reaction(Day1, day 2, day 4 and day 7 post surgery)
- Hypercapnia (pCO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))(During Surgery)
- Presence of loco-regional lesions related to the insertion of the trocar (Tolerance of laparoscopy)(up to 3 months)
- Postoperative biological inflammatory reaction(Day 7 post surgery)
- Postoperative intestinal morbidity: Rate of intestinal stenosis post-ECUN(up to 3 months)
- Length of hospitalization(up to 3 months)
- Oxygen saturation (SaO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))(During Surgery)
- Blood pressure (BP) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))(During Surgery)
- Medium-term postoperative neurological morbidity(up to 3 months)
- Cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))(During Surgery)