Direct Oral Feeding Following Minimally Invasive Esophagectomy (NUTRIENT II trial)

Abstract

Objective: Patients undergoing an esophagectomy are often kept nil-by-mouth postoperatively out of fear for increasing anastomotic leakage and pulmonary complications. This study investigates the effect of direct start of oral feeding following minimally invasive esophagectomy (MIE) compared with standard of care. Background: Elements of enhanced recovery after surgery (ERAS) protocols have been successfully introduced in patients undergoing an esophagectomy. However, start of oral intake, which is an essential part of the ERAS protocols, remains a matter of debate. Methods: Patients in this multicenter, international randomized controlled trial were randomized to directly start oral feeding (intervention) after a MIE with intrathoracic anastomosis or to receive nil-by-mouth and tube feeding for 5 days postoperative (control group). Primary outcome was time to functional recovery. Secondary outcome parameters included anastomotic leakage, pneumonia rate, and other surgical complications scored by predefined definitions. Results: Baseline characteristics were similar in the intervention (n = 65) and control (n = 67) group. Functional recovery was 7 days for patients receiving direct oral feeding compared with 8 days in the control group (P = 0.436). Anastomotic leakage rate did not differ in the intervention (18.5%) and control group (16.4%, P = 0.757). Pneumonia rates were comparable between the intervention (24.6%) and control group (34.3%, P = 0.221). Other morbidity rates were similar, except for chyle leakage, which was more prevalent in the standard of care group (P = 0.032). Conclusion: Direct oral feeding after an esophagectomy does not affect functional recovery and did not increase incidence or severity of postoperative complications.

Needle Catheter Jejunostomy in Patients Undergoing Surgery for Upper Gastrointestinal and Pancreato-Biliary Cancer–Impact on Nutritional and Clinical Outcome in the Early and Late Postoperative Period

“…The study is limited by the retrospective analysis and a potential selection bias. Since the evidence for early oral food intake after esophagectomy and gastrectomy came up more recently [2,40] the restrictions within the first days were very "traditional". Nevertheless, all calorie intake will be inappropriate for a longer period of time.…”

“…In the time of Enhanced Recovery after Surgery programs (ERAS), perioperative nutrition therapy seems to be very "traditional" and even redundant [1]. Early oral feeding is feasible even after esophagectomy and without impact on the incidence and severity of postoperative complications [2].…”

Hybrid Minimally Invasive Esophagectomy–Surgical Technique and Results

“…ERAS protocols resulted in faster recovery from surgery and reduced morbidity rates in observational studies [17]. RCTs have been done only rarely on aspects of ERAS protocols after esophagectomy [18]. Overall, ERAS protocols can be judged as safe, feasible, and promising, but without an evidence-based effect on patient outcomes [19].…”

Effect of direct oral feeding following minimally invasive esophagectomy on costs and quality of life

“…For this study, we used data of patients participating in the NUTritional Route In Esophageal Resection Trial (NUTRIENT) II study. 14 The NUTRIENT II study was approved by the Medical Ethics Committee United (MEC-U) and registered at ClinicalTrials.gov with the registration number NCT02378948 and at the Dutch trial registry with registration number NTR4972. The NUTRIENT II study was a multicenter prospective open-label randomized controlled trial performed at two hospital units in the Netherlands and one hospital in Sweden between October 1, 2015, and May 14, 2018.…”

“…Recently it was demonstrated that direct oral feeding was well tolerated and resulted in a similar functional recovery and complication rate compared to standard of care. 14 Patients in the intervention group directly started a oral diet whereas patients in standard of care received nil-by-mouth for the first 5 days after surgery and tube feeding.…”