Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis

NCT05882448 | Recruiting

• 1 other identifier: APHP221170
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Preterm Birth; Enterocolitis, Necrotizing

Outcome Measures

Primary Outcomes (1)

• C reactive protein blood level

  C reactive protein blood level

  between Day 0 and Day 2 post surgery

Secondary Outcomes (16)

• Postoperative biological inflammatory reaction

  Day 7 post surgery

• Specific post-operative biological inflammatory reaction

  Day1, day 2, day 4 and day 7 post surgery

• Postoperative mortality

  up to 3 months

• Postoperative intestinal morbidity: stoma rate

  up to 3 months

• Postoperative intestinal morbidity: Duration of parenteral nutrition

  up to 3 months

Study Arms (2)

Laparotomy

ACTIVE COMPARATOR

Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion

Procedure: laparotomy

Laparotomy and laparoscopy

EXPERIMENTAL

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.

Procedure: laparotomy; Procedure: Laparoscopy

Interventions

laparotomy PROCEDURE

Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion

Laparotomy; Laparotomy and laparoscopy

Laparoscopy PROCEDURE

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.

Laparotomy and laparoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Instability contraindicating movement to the operating room or contraindicating CO2 insufflation
• Diagnosis of isolated perforation of the small intestine (radiography:
• pneumoperitoneum without pneumatosis)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale

Paris, 75012, France

RECRUITING

Hôpital Robert Debré Service de Chirurgie Pédiatrique

Paris, France

RECRUITING

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Interventions

Laparotomy; Laparoscopy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Central Study Contacts

Louise MONTALVA, Dr

CONTACT

+33 1.71.73.89.97; louise.montalva@aphp.fr

Arnaud BONNARD, Pr

CONTACT

+33 1 40 03 23 59; arnaud.bonnard@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel assignment

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 31, 2023
• Study Start: February 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (2)