Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer

October 14, 2015 updated by: Yin Li

Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer: a Randomized Clinical Trial

The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in patients with esophagectomy, the preference for this modality also rests on the traditional but undocumented reluctance to allow food at will. These assumed hazards of allowing normal food in the immediate postoperative period have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality. Whether early oral feeding after esophagectomy affects the incidence of life-threatening surgical complications, shortens the recovery time of bowel function and the postoperative hospital stay, improves postoperative quality of life in comparison with artificial feeding modality remains unclear. The investigators compared a routine of allowing liquid food at will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the first 7 postoperative days. The main endpoint is the incidence rate of complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The literature concludes that patients should be allowed food without delay (at will) after colorectal surgery and that the customary withholding of oral intake (nil-by-mouth) for the first postoperative days is unnecessary. Robust data also suggest that the investigators should avoid the nil-by-mouth regimen after major gynecologic, urologic, and vascular surgery. The safety of early oral feeding after esophagectomy has not been investigated previously.In 2008, the results of a randomized multicenter clinical trial investigating whether a routine of allowing normal food at will immediately increases morbidity after major upper gastrointestinal surgery showed that allowing patients to eat normal food at will from the first day after major upper gastrointestinal surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding. The assumed hazards of allowing oral food intake in the immediate postoperative period in patients with esophagectomy have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality.

This is a randomized study investigating the role of early oral feeding in patients with esophagectomy.In the early oral feeding group nasogastric tube is not placed routinely and patients are encouraged to intake liquid food on postoperative day 1 (POD1). In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of POD 1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h. Esophagography is performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomotic leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. The complications defined in previous study and bowel function and recovery were recorded carefully. The primary end point of this study is the postoperative complications and the secondary end points are quality of life,bowel function recovery time and length of postoperative stay between the two groups. The investigators estimated the minimum rate of patients with complications in control group population at 23%. An increase of this to 36% was considered clinically important. Detecting a difference of this magnitude or greater at a level of statistical significance of 0.05 and a power of 0.90 with a one-tailed test of proportions required a total of 130 patients in each group.Considering the rate of drop-out a total of 280 patients will be enrolled in this study.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adults subject to thoracolaparoscopic esophagectomy for esophageal cancer.

Exclusion Criteria:

Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b). Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.

Patients with unstable situation after surgery (eg, need ventilation and ICU treatment) Patients medically unfit for surgical resection. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.

Mentally disabled. Expected life duration of less than 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early oral feeding group
In this goup patients with esophagectomy are encouraged to begin the oral intake carefully and adjust according to tolerance on post operative day 1.
Dietary supplement: early oral feeding
In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.
NO_INTERVENTION: Delayed oral feeding group
In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of post operative day1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h.Esophagography was performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomosis leakage, and a full liquid diet was implemented on the following day and enteral infusion halted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication
Time Frame: an expected average of 4 weeks
postoperative complications are graded according to Clavin-Dindo grading system
an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life assessment
Time Frame: 6 months
6 months
Length of postoperative stay
Time Frame: an expected average of 2 weeks
an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yin Li

Investigators

  • Principal Investigator: Yin Li, Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 23, 2013

First Posted (ESTIMATE)

November 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on early oral feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe