Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- clinical parameters
Study Overview
Brief Summary
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.
Exclusion Criteria
- •patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.
Arms & Interventions
conventional pathway group
The conventional pathway group received conventional care.
ERAS group
Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.
Intervention: ERAS (Procedure)
Outcomes
Primary Outcomes
clinical parameters
Time Frame: One week after operation
length of post-operative stay
Secondary Outcomes
- Postoperative complications(30 days after operation)