Influence of Early-feeding on Digestive Function of Patients After Esophageal Recontraction Surgery

NCT05892263 | Unknown

• 1 other identifier: 202205077MIND
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

After esophagectomy and reconstruction, intestinal ischemia or intestinal paralysis, lack of intestinal stimulation and oral nutrition can aggravate atrophy and impair the permeability of intestinal mucosa, which not only makes it easy for intestinal bacteria and endotoxin to migrate and enter the blood, At present, early intestinal feeding has been proved to protect the integrity of the intestinal mucosa and improve the postoperative systemic inflammatory response and infection rate of patients, especially pneumonia. Relying on parenteral nutrition, coupled with postoperative exhaust gas or defecation with drugs, can be force-fed. In addition to the side effects of gastrointestinal discomfort (nausea, diarrhea, abdominal pain), parenteral nutrition is likely to cause blood sugar instability and liver index. Abnormal and even increased infection rate, gastrointestinal force feeding was delayed for 36-48 hours before starting. At present, there is no research on the effect of early force-feeding on gastrointestinal motility. Therefore, this study aims to explore whether early gastrointestinal force-feeding can not only reduce the infection rate and systemic inflammation, but also promote gastrointestinal motility. Without using drugs, Reduce drug side effects and abdominal discomfort, advance the time of gastrointestinal force-feeding, reduce complications of postoperative lung and wound anastomosis leakage, complete postoperative care for esophageal cancer, and reduce postoperative mortality. At present, there is no research on the effect of early force-feeding on gastrointestinal motility. Therefore, this study aims to explore whether early gastrointestinal force-feeding can not only reduce the infection rate and systemic inflammation, but also promote gastrointestinal motility. Without using drugs, Reduce drug side effects and abdominal discomfort, advance the time of gastrointestinal force-feeding, reduce complications of postoperative lung and wound anastomosis leakage, complete postoperative care for esophageal cancer, and reduce postoperative mortality.

Conditions

Early-feeding

Outcome Measures

Primary Outcomes (1)

• gastrointestinal emptying time

  Start timing the first bowel movement or exhaust time after surgery

  up to 24 hours (time of the first bowel movement or exhaust after surgery )

Study Arms (3)

Early intestinal force-feeding and drugs to promote gastrointestinal motility

EXPERIMENTAL

Other: early feeding

early enteral feeding

EXPERIMENTAL

Other: early feeding

giving force-feeding after gas or defecation

NO INTERVENTION

Interventions

early feeding OTHER

Enteral force feeding with 5% dextrose injection within 24 hours after operation

Early intestinal force-feeding and drugs to promote gastrointestinal motility; early enteral feeding

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Esophagectomy
• Esophagectomy ＆ reconstruction
• Esophagotomy
• Esophageal reconstruction-with gastric tube
• Esophageal reconstruction-with colon
• Esophageal reconstruction with small intestine

You may not qualify if:

• Gastrointestinal perforation
• Postoperative hemorrhage
• Intestinal obstruction
• Shock

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: June 7, 2023
• Study Start: November 1, 2022
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: June 7, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)