Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
NCT ID: NCT03997162
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
52 participants
OBSERVATIONAL
2018-10-11
2026-02-04
Brief Summary
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Detailed Description
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I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.
II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.
III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.
OUTLINE:
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
After completion of study, participants are followed up at days 14, 30, 80-110, and 170-200, and at 11-14 months.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
Best Practice
Complete standard of care enhanced recovery after surgery protocol
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Complete standard of care enhanced recovery after surgery protocol
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with clinical stage 0-IIIC will be included.
* Any performance status and any life expectancy.
* The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.
* Prior therapy will not be used as a limitation in this study.
Exclusion Criteria
* Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
18 Years
99 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yanghee Woo
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2018-01639
Identifier Type: REGISTRY
Identifier Source: secondary_id
17482
Identifier Type: OTHER
Identifier Source: secondary_id
17482
Identifier Type: -
Identifier Source: org_study_id
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