ERAS for Patients Received Neoadjuvant Chemotherapy

NCT03272984 | Completed DMC

• 1 other identifier: 8150041701
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative length of stay

  Postoperative length of stay

  1 month

Secondary Outcomes (3)

• Postoperative complications

  2 months

• The time to first flatus

  1 week

• Time to semi-liquid diet

  2 week

Study Arms (2)

ERAS group

EXPERIMENTAL

Patients will undergo the ERAS programs.

Procedure: ERAS group

SC group

OTHER

Patients will undergo the SC group.

Procedure: SC group

Interventions

ERAS group PROCEDURE

ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.

ERAS group

SC group PROCEDURE

Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.

SC group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
• Age older than 18 and younger than 75 years.
• American Society of Anesthesiologists (ASA) class: I-III.
• Participants can describe the symptom objectively and cooperate actively.
• Written informed consent.

You may not qualify if:

• Patients allergic to oxaliplatin, tegafur gimerac etc.
• Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> II (NYHA)
• Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
• Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr \< 25 ml/min).
• Patients who require simultaneous surgery for other diseases.
• Patients who received upper abdominal surgery previously.
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• JIANG Zhi-Wei: lead

Study Sites (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhiwei JIANG, MD

  Jinling Hospital, Medical School of Nanjing University

  PRINCIPAL INVESTIGATOR

• Jian ZHAO, MD

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Research Institute of General Surgery

Model Details: This study is a parallel, open-label randomized controlled trial.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: April 1, 2015
• Primary Completion: June 5, 2017
• Study Completion: July 6, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

CN (1)