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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: fast-track surgery
* Procedure: conventional postoperative care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fast-track surgery<br>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. | Procedure: fast-track surgery<br>* 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.<br>|
| Other: conventional postoperative care<br>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. | Procedure: conventional postoperative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| food intake time |  | within the first 30 days (plus or minus 3 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | one year | 
| readmission |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fast-track surgery, laparoscopic gastrectomy