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

Gastric Cancer Clinical Trial

— FTSlapAG  

Official title:

Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955096
• Other study ID #: 2013-172
• Secondary ID: 2013-172
• Status: Completed
• Phase: N/A
• First received: September 25, 2013
• Last updated: October 8, 2013
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quan Wang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation time		within the first 30 days (plus or minus 3 days) after surgery
Primary	defection time		within the first 30 days (plus or minus 3 days) after surgery
Primary	food intake time		within the first 30 days (plus or minus 3 days) after surgery
Secondary	Complications		one year
Secondary	readmission		one year