Early Oral Feeding After Total Gastrectomy for Cancer
A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer
1 other identifier
interventional
112
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 14, 2013
October 1, 2013
2.9 years
October 9, 2013
October 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative hospital stay
Time between surgery and patient discharge
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary Outcomes (1)
Morbidity
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Other Outcomes (4)
Re-admissions
30 days after discharge
Effective oral feeding
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Quality of life
Preoperatively, postoperative day 7, 14 days after discharge
- +1 more other outcomes
Study Arms (2)
Early oral feeding
EXPERIMENTALEarly oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3
Delayed oral feeding
NO INTERVENTIONDelayed oral feeding starting with liquids on postoperative day (POD) 4, followed by a soft diet on POD 5, and solid foods on day 6
Interventions
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
Eligibility Criteria
You may qualify if:
- Total gastrectomy for cancer
- Age 18 - 80 years
- Informed consent
You may not qualify if:
- Numerous hepatic and peritoneal metastases
- Extended resections (pancreas, colon)
- Preoperative malnutrition requiring total parenteral nutrition
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Department of Surgery, Jagiellonian University Medical College
Krakow, Malopolska, 31-501, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Kulig, prof.
First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 14, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 14, 2013
Record last verified: 2013-10