NCT02378948

Brief Summary

The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative functional recovery after an esophagectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

February 23, 2015

Last Update Submit

January 30, 2019

Conditions

Esophageal Neoplasms

Keywords

EsophagectomyNutritionOral feedingEnteral feedingPulmonary complicationsAnastomotic leakageQuality of life

Outcome Measures

Primary Outcomes (1)

  • Functional recovery

    The primary outcome parameter is the day of functional recovery. Functional recovery is defined as postoperative patients who are free of IV fluid, have adequate pain control, restoration of mobility to an independent level, have sufficient caloric intake and no signs of active infection.

    up to 4 weeks after surgery

Secondary Outcomes (9)

  • Pulmonary complications

    up to 4 weeks after surgery

  • Anastomotic leakage

    up to 4 weeks after surgery

  • Nutritional status (weight loss, intake)

    postoperative day 2, 5 and 14

  • Need for parenteral feeding/ placement of a nasojejunal feeding tube

    up to 2 weeks after surgery

  • Need for additional surgical, radiological or endoscopic interventions

    up to 4 weeks after surgery

  • +4 more secondary outcomes

Study Arms (2)

Early oral feeding

EXPERIMENTAL

Liquid oral feeding directly after esophagectomy.

Dietary Supplement: Liquid oral feeding

Delayed oral feeding

NO INTERVENTION

Liquid oral feeding 5 days after esophagectomy

Interventions

Liquid oral feedingDIETARY_SUPPLEMENT

Liquid oral feeding (water, soup, porridge, nutritional supplements etc.)

Early oral feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that undergo a (minimally invasive) esophagectomy with intrathoracic anastomosis.
  • written informed consent
  • age \>18 years

You may not qualify if:

  • Inability for oral intake
  • Inability to place a surgical feeding jejunostomy
  • Mental retardation
  • Swallowing disorder
  • Achalasia
  • Malnutrition (defined as \>15% weight loss just before start of the surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Overijssel, 7609PP, Netherlands

Location

Related Publications (1)

  • Berkelmans GH, Wilts BJ, Kouwenhoven EA, Kumagai K, Nilsson M, Weijs TJ, Nieuwenhuijzen GA, van Det MJ, Luyer MD. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial. BMJ Open. 2016 Aug 5;6(8):e011979. doi: 10.1136/bmjopen-2016-011979.

    PMID: 27496239DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Misha DP Luyer, MD, PhD

    Catharina Ziekenhuis Eindhoven

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 4, 2015

Study Start

October 1, 2015

Primary Completion

June 12, 2018

Study Completion

November 1, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

NL(2)