Clinical trial NCT04464057: Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
Official title: Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Feeding
Neonate
Infant
Intestinal Anastomosis Complication
Keywords: oral feeding
early enteral nurtrion
Intestinal anastomosis
neonate
infant
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 947
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective, randomized controlled clinical study. A total of 285 inpatients (95 experimental groups and 190 control groups) were enrolled to evaluate the safety and effectiveness of early feeding in neonates and infants after intestinal anastomosis
Primary purpose: TREATMENT

Brief summary: The study is primary designed to evaluate the safety and effectiveness of early feeding after bowel anastomosis, and observe the effect of early postoperative feeding on promoting postoperative rehabilitation and reducing parenteral nutrition

Detailed description: Intestinal anastomosis is a common operation for the treatment of digestive tract diseases of newborns and infants. It is not be defined that when should begin oral feeding after intestinal anastomosis. Poor anastomotic healing or anastomotic leakage is the most serious complication after intestinal anastomosis, which often leads to severe abdominal infection, peritonitis and even death. Nowadays, it is believed that the causes of poor anastomotic healing or anastomotic leakage are various, including contaminated during the operation, the blood supplyment of the bowel edges at both ends of the anastomosis, anemia, anastomosis technique, type of surgery (selective or emergency), and anastomotic tension . The traditional view is that early feeding may increase the anastomotic tension, which may lead to poor anastomotic healing or leakage, so a lot of surgeons often take a fasting for 4-5 days after intestinal anastomosis to ensure good anastomotic healing, however there is no enough evidence for this view. On the contrary, the current research confirms that after intestinal anastomosis, under fasting conditions, the digestive system still has 1-2 liters of fluid through the anastomosis, so even if it is given postoperative oral feeding, It would not excessively increase the digestive fluid through the anastomosis. Obviously, the early guess that the anastomotic tension is increased is lacking in theoretical evidence. In recent years, with the in-depth study of intestinal function, intestinal mucosal barrier function and intestinal flora, early enteral nutrition has stretched more and more attention, which is believed could stimulate intestinal digestive fluid secretion, promote intestinal mucosal metabolism and repair, avoid intestinal villi atrophy, reduce intestinal bacterial translocation, promote intestinal function recovery and intestinal peristalsis. Postoperative intestinal obstruction is also an important reason for hindering early enteral nutrition, but current research believes that postoperative intestinal obstruction is often temporary, and in most cases will be relieved 4-8 hours after surgery. European Society of Parenteral Enteral Nutrition (ESPEN ) recommended that enteral nutrition should be performed within 24 hours after intestinal anastomosis, but it needs to be fully evaluated according to the children's own tolerance and the type of surgery. A large number of studies and meta-analysis have confirmed that early enteral nutrition is safe and feasible after intestinal anastomosis in adults, but there are still few studies in children, especially whether early enteral surgery can be performed after intestinal anastomosis is currently rarely reported in neonates and infants. This study evaluated the feasibility and effectiveness of early oral enteral nutrition in neonates and infants after intestinal anastomosis through a prospective study.

Eligibility criteria: Inclusion Criteria:

* (1)neonates or infants less than 12 months (2)Intestinal anastomosis, including small intestine and colon anastomosis

Exclusion Criteria:

* (1) Premature infants or children with a weight of less than 2.5 kg during surgery are excluded (2) Exclude cases of severe abdominal infection (3) Exclude cases of severe imbalance of the proximal and distal intestinal canal of the anastomosis (such as intestinal atresia)

Primary outcomes:
measure: Anastomotic leakage or poor anastomotic healing
timeFrame: 1-7days after early oral feeding
measure: Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.
timeFrame: 1-14days after early oral feeding
measure: indexs of stress:C-reactive protein, interleukin 6, cortisol
timeFrame: The first day and third day after early oral feeding
measure: indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein
timeFrame: The seventh day after anastomosis
Secondary outcomes:
measure: indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay
timeFrame: 1-14 days after surgery.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hispital
state: Anhui
city: Xuzhou
country: China
facility: Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College
state: Jiangsu
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Weibing Tang, Dr
role: STUDY_DIRECTOR
References: