Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT01955096
• Lead Sponsor: Quan Wang

Brief Summary

The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.

Detailed Description

Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-29
• Status Verified: 2013-10
• Study First Posted: 2013-10-07
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.

Exclusion Criteria

• Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
food intake time	within the first 30 days (plus or minus 3 days) after surgery
Ambulation time	within the first 30 days (plus or minus 3 days) after surgery
defection time	within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Name	Time	Method
Complications	one year
readmission	one year