Trials / Active Not Recruiting
Active Not RecruitingNCT03997162
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Gastric Cancer Enhanced Recovery After Surgery Pathway
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 52 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.
Detailed description
PRIMARY OBJECTIVES: 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
- Clinical Stage 0 Gastric Cancer AJCC v8
- Clinical Stage I Gastric Cancer AJCC v8
- Clinical Stage II Gastric Cancer AJCC v8
- Clinical Stage IIA Gastric Cancer AJCC v8
- Clinical Stage IIB Gastric Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Gastric Adenocarcinoma
- Pathologic Stage 0 Gastric Cancer AJCC v8
- Pathologic Stage I Gastric Cancer AJCC v8
- Pathologic Stage IA Gastric Cancer AJCC v8
- Pathologic Stage IB Gastric Cancer AJCC v8
- Pathologic Stage II Gastric Cancer AJCC v8
- Pathologic Stage IIA Gastric Cancer AJCC v8
- Pathologic Stage IIB Gastric Cancer AJCC v8
- Pathologic Stage III Gastric Cancer AJCC v8
- Pathologic Stage IIIA Gastric Cancer AJCC v8
- Pathologic Stage IIIB Gastric Cancer AJCC v8
- Pathologic Stage IIIC Gastric Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Best Practice | Complete standard of care enhanced recovery after surgery protocol |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2018-10-11
- Primary completion
- 2023-01-18
- Completion
- 2027-01-07
- First posted
- 2019-06-25
- Last updated
- 2026-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03997162. Inclusion in this directory is not an endorsement.