The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative recovery and pulmonary complications following esophagectomy. This is a non-inferiority trial.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Functional recovery
Secondary outcome
- Pulmonary complications (Pneumonia, Acute respiratory distress syndrome
(ARDS), respiratory insufficiency requiring treatment)
- Anastomotic leakage (clinically and amylase levels in drain fluid)
- Nutritional status (weight loss, sarcopenia, intake)
- Need for parenteral feeding/ placement of a nasojejunal feeding tube
- Need for additional surgical, radiological or endoscopic interventions
- 30-day surgical complications (classified according to Clavien-Dindo)
- Other complications requiring treatment (i.e. urinary tract infection)
- Need for ICU admission and total length of ICU stay
- Quality of life
Background summary
Early oral feeding is safe and beneficial in most types of gastro-intestinal
surgery and is a crucial part of fast track or enhanced recovery protocols.
Following esophagectomy, fast track programs are increasingly being applied,
resulting in a reduced length of stay, perioperative morbidity and hospital
charges. However, the feasibility and safety of oral intake directly following
esophagectomy remains unclear.
Mostly, a nil-by-mouth regimen is applied during the first postoperative week,
to reduce the incidence and severity of postoperative pneumonia and anastomotic
leakage. Since early enteral nutrition following esophagectomy is considered to
be beneficial a nasojejunal tube or jejunostomy tube is placed to bypass the
oral route. In this way, patients are subjected to the discomfort and
complications of a nasojejunal tube or jejunostomy tube, potentially hampering
their recovery.
Two retrospective studies investigated a further delay of the initiation of
oral nutrition, even up to four weeks following esophagectomy. Both studies
found a significant reduction in anastomotic leakage with an extended delay of
oral nutrition following esophagectomy compared to a conventional 5-7 days nil
by mouth regimen. However, these studies were at risk for bias and
extrapolation of these results to the clinical situation may not be valid.
On the other hand, early initiation of oral nutrition has been shown to be
feasible in many types of gastrointestinal surgery, including upper
gastrointestinal surgery. Furthermore, in a previous feasibility study
(Nutrient I trial) has been shown that direct oral intake following
esophagectomy was feasible and did not result in an increase of major
complications. An important argument to delay oral intake is the risk of
(aspiration) pneumonia. The feasibility trial showed that pulmonary
complications were not significantly different in patients that were fed orally
directly, when compared with a historical cohort in which oral intake was
delayed. Interestingly, direct oral intake even resulted in less postoperative
pulmonary complications.
It remains unclear what the best strategy is for nutrition in the early
postoperative phase following esophagectomy.
Study objective
The aim of this study is to investigate the effects of early start versus
delayed start of oral intake on postoperative recovery and pulmonary
complications following esophagectomy. This is a non-inferiority trial.
Study design
A prospective randomized controlled trial (RCT) performed at the Catharina
Hospital Eindhoven and the Hospital Group Twente.
Intervention
Early oral feeding after an esophagectomy. Patients will start a liquid oral
diet directly postoperatively.
Study burden and risks
Patients will recieve either oral feeding or enteral feeding, during the
firstfive days postoperatively. Both feedings routes are without extra risks
for the patient. The extent of the burden is not different from normal standard
care during the postoperative period.
michelangelolaan 2
Eindhoven 5623 EJ
NL
michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
• Patients that undergo a minimally invasive/hybrid esophagectomy with intrathoracic anastomosis for cancer.
• written informed consent
• age >18 years
Exclusion criteria
• Inability for oral intake
• Inability to place a surgical feeding jejunostomy
• Inability to provide written consent or inability to fill out questionnaires
• Swallowing disorder
• Achalasia
• Malnutrition (defined as >15% weight loss just before start of the surgery)
• Karnofsky Performance Status < 80
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT02378948 |
CCMO | NL52591.060.15 |
OMON | NL-OMON21339 |