Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants

Infant Clinical Trial

Official title:

Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464057
• Other study ID #: NanjingCH
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2022
• Source: Nanjing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: August 31, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Enteral Feeding
• Infant
• Intestinal Anastomosis Complication
• Neonate

Intervention

Dietary Supplement:
• early oral feeding or early enteral nurtrion
The patients in the experimental group were fed orally within 24-48 hours after intestinal anastomosis. Start taking it at 24-48 hours after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.

Locations

Country	Name	City	State
China	Anhui Provincial Children's Hispital	Hefei	Anhui
China	Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Weibing Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage or poor anastomotic healing	Feces flow out from the site of the anastomosis into the abdominal cavity	1-7days after early oral feeding
Primary	Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent.	There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.	1-14days after early oral feeding
Primary	indexs of stress:C-reactive protein, interleukin 6, cortisol	Some indexs could be defined as indicators of the severity of the stress response	The first day and third day after early oral feeding
Primary	indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein	Some indexs could be defined as indicators of the nutriton status	The seventh day after anastomosis
Secondary	indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay	Some indexs could be defined as indicators of recovery after surgery.	1-14 days after surgery.