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Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial

Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03046303
Enrollment
400
Registered
2017-02-08
Start date
2017-02-20
Completion date
2019-01-30
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrostomy Complications

Keywords

ERAS,gastric cancer

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.

Interventions

PROCEDUREERAS

optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
clinical parametersOne week after operationlength of post-operative stay

Secondary

MeasureTime frameDescription
Postoperative complications30 days after operationwound infection;post-opeartion bleeding;ileus;stenosis;leakage

Countries

China

Contacts

Primary ContactQuan Wang, MD
wangquan5607@126.com+86-431-81875607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026