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

NCT ID: NCT04464057

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 947 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-08-31

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.

Conditions

Enteral Feeding; Neonate; Infant; Intestinal Anastomosis Complication

Keywords

oral feeding; early enteral nurtrion; Intestinal anastomosis; neonate; infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental group

The patients in the experimental group would be given early oral feeding 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.

Group Type: EXPERIMENTAL

early oral feeding or early enteral nurtrion

Intervention Type: DIETARY_SUPPLEMENT

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.

control group

The control group would be given early oral feeding within 4-5 days after intestinal anastomosis. Start taking it at 4-5 days after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weibing Tang

OTHER

Sponsor Role: lead

Responsible Party

Weibing Tang

Chief of neonatal surgery department of Nanjing Children's Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Weibing Tang, Dr

Role: STUDY_DIRECTOR

Children's Hospital of Nanjing Medical University

Locations

Anhui Provincial Children's Hispital

Hefei, Anhui, China

Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College

Xuzhou, Jiangsu, China

Countries

China

References

Lu C, Sun X, Geng Q, Tang W. Early oral feeding following intestinal anastomosis surgery in infants: a multicenter real world study. Front Nutr. 2023 Jul 20;10:1185876. doi: 10.3389/fnut.2023.1185876. eCollection 2023.

Reference Type: DERIVED

PMID: 37545580 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NanjingCH

Identifier Type: -

Identifier Source: org_study_id