Early Oral Feeding After Total Gastrectomy for Cancer

October 10, 2013 updated by: Marek Sierzega, Jagiellonian University

A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer

The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Kraków, Malopolska, Poland, 31-501
        • Recruiting
        • First Department of Surgery, Jagiellonian University Medical College
        • Contact:
        • Principal Investigator:
          • Jan Kulig, Prof.
        • Sub-Investigator:
          • Marek Sierzega, MD, PhD
        • Sub-Investigator:
          • Piotr Kolodziejczyk, Prof.
        • Sub-Investigator:
          • Ryszard Choruz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total gastrectomy for cancer
  • Age 18 - 80 years
  • Informed consent

Exclusion Criteria:

  • Numerous hepatic and peritoneal metastases
  • Extended resections (pancreas, colon)
  • Preoperative malnutrition requiring total parenteral nutrition
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early oral feeding
Early oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3
Dietary supplement: Early oral feeding
Oral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter
NO_INTERVENTION: Delayed oral feeding
Delayed oral feeding starting with liquids on postoperative day (POD) 4, followed by a soft diet on POD 5, and solid foods on day 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Time between surgery and patient discharge
Participants will be followed for the duration of hospital stay, an expected average of 8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Any complication occurring during hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 8 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-admissions
Time Frame: 30 days after discharge
Hospital readmissions within 30 days after discharge
30 days after discharge
Effective oral feeding
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Time to reach oral feeding covering 75% of patient's requirements
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Quality of life
Time Frame: Preoperatively, postoperative day 7, 14 days after discharge
Quality of life measured by EORTC QLQ-C30 and EORTC QLQ - STO22
Preoperatively, postoperative day 7, 14 days after discharge
Laboratory parameters
Time Frame: Preoperatively, postoperative day 1 and 8
Laboratory tests, including lymphocyte count, blood albumin, blood prealbumin
Preoperatively, postoperative day 1 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Jan Kulig, prof., First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (ESTIMATE)

October 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K/ZDS/002306 (OTHER: Jagiellonian University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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