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

An International, Multicenter, Open-label Randomized Controlled Trial

Berkelmans, Gijs H. K. MD*; Fransen, Laura F. C. MD*; Dolmans-Zwartjes, Annemarie C. P. MANP*; Kouwenhoven, Ewout A. MD, PhD; van Det, Marc J. MD, PhD; Nilsson, Magnus MD, PhD; Nieuwenhuijzen, Grard A. P. MD, PhD*; Luyer, Misha D. P. MD, PhD*

doi: 10.1097/SLA.0000000000003278
Randomized Controlled Trial: PDF Only
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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.

*Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands

Department of Surgery, ZGT Hospital Group Twente, Almelo, the Netherlands

Division of Surgery, CLINTEC, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.

Reprints: Misha D. P. Luyer, MD, PhD, Department of Surgery, Catharina Hospital, 5623EJ Eindhoven, the Netherlands. E-mail: misha.luyer@catharinaziekenhuis.nl.

Both G.H.K.B and L.F.C.F have shared first authorship and contributed equally.

This randomized trial was funded by KWF Kankerbestrijding (Dutch Cancer Society, project number 10495) and Covidien/Medtronic.

The authors have declared no conflict of interest.

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