Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998230
• Other study ID #: HenanCH
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2013
• Last updated: October 14, 2015
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Dietary Supplement:
• early oral feeding
In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.

Locations

Country	Name	City	State
China	Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Yin Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication	postoperative complications are graded according to Clavin-Dindo grading system	an expected average of 4 weeks	Yes
Secondary	Quality of Life assessment		6 months	No
Secondary	Length of postoperative stay		an expected average of 2 weeks	No