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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale
RECRUITING
Paris
Hôpital Robert Debré Service de Chirurgie Pédiatrique
RECRUITING
Paris
Contact Information
Primary
Louise MONTALVA, Dr
louise.montalva@aphp.fr
+33 1.71.73.89.97
Backup
Arnaud BONNARD, Pr
arnaud.bonnard@aphp.fr
+33 1 40 03 23 59
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2025-09
Participants
Target number of participants: 54
Treatments
Active_comparator: Laparotomy
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
Experimental: Laparotomy and laparoscopy
Exploratory and therapeutic laparotomy if necessary preceded by laparoscopy with insufflation of CO2 (placement of a 3mm trocar in the left hypochondrium and insufflation of a pneumoperitoneum (carbon dioxide, pressure: 6 mmHg, flow rate: 1.5 Liter/minute) for a duration of at least 5 minutes.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov