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

Sponsor
Weibing Tang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04464057
Collaborator
(none)
562
2
2
25
281
11.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: early oral feeding or early enteral nurtrion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
562 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 anastomosisThe 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
Masking:
Single (Participant)
Masking Description:
According to age and disease, the first pairing design, three pairs (experimental group: control group = 1:2), after pairing three subjects randomly assigned to the experimental group, the other two to the control group
Primary Purpose:
Treatment
Official Title:
Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Anastomotic leakage or poor anastomotic healing [1-7days after early oral feeding]

    Feces flow out from the site of the anastomosis into the abdominal cavity

  2. Gastrointestinal symptoms:nausea, vomiting, diarrhea, abdominal pain and abdominal distent. [1-14days after early oral feeding]

    There may be some unexpected symptoms happen after early oral feeding after anastomosis such as Nausea, vomiting, diarrhea, abdominal pain and abdominal distent.

  3. indexs of stress:C-reactive protein, interleukin 6, cortisol [The first day and third day after early oral feeding]

    Some indexs could be defined as indicators of the severity of the stress response

  4. indexs of nurtrion:weight, serum albiumin,serum prealbumin and serum retinol binding protein [The seventh day after anastomosis]

    Some indexs could be defined as indicators of the nutriton status

Secondary Outcome Measures

  1. indexs of recovery after surgery:Time to first bowel movement, time to use intravenous nutrition and total postoperative hospital stay [1-14 days after surgery.]

    Some indexs could be defined as indicators of recovery after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Children's Hispital Hefei Anhui China
2 Xuzhou CHildren's Hospital Affilated to Xuzhou Medical College Xuzhou Jiangsu China 210000

Sponsors and Collaborators

  • Weibing Tang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Tang, Chief of neonatal surgery department of Nanjing Children's Hospital, Nanjing Children's Hospital
ClinicalTrials.gov Identifier:
NCT04464057
Other Study ID Numbers:
  • NanjingCH
First Posted:
Jul 9, 2020
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weibing Tang, Chief of neonatal surgery department of Nanjing Children's Hospital, Nanjing Children's Hospital

Study Results

No Results Posted as of Jul 9, 2020