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

Gastrostomy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046303
• Other study ID #: ERAS for Radical gastrectomy
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2017
• Last updated: February 5, 2017
• Start date: February 20, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: February 2017
• Source: First Hospital of Jilin University
• Contact: Quan Wang, MD
• Phone: +86-431-81875607
• Email: wangquan5607[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 30, 2019
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy Complications

Intervention

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

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical parameters	length of post-operative stay	One week after operation
Secondary	Postoperative complications	wound infection;post-opeartion bleeding;ileus;stenosis;leakage	30 days after operation