Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): early oral feeding
Intervention type(s): Dietary Supplement
Intervention description(s): In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal cancer; esophagectomy; oral feeding