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

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: fast-track surgery; Procedure: conventional postoperative care

• 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

Arm && Interventions

Group	Intervention	Description
fast-track surgery	fast-track surgery	The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
conventional postoperative care	conventional postoperative care	The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.

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