Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction

Study Overview
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Brief Summary
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The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.

Detailed Description
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In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.

Official Title
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A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer

Conditions
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Peristaltic Direction, Roux-en-Y Gastrointestinal Anastomosis, Gastric Cancer

Intervention / Treatment
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* Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Pathological examination confirmation the adenocarcinoma of stomach before surgery 2) Physical conditions compliance with the requirements for curative gastrectomy 3) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3 4) Comply with the protocol during the whole study period 5) No neoadjuvant therapy administration 6) Sign informed consent and permission of withdraw in the whole study period 7) Consent to provide the tissue specimens after surgery for this study 8) Estimation the overall survival after surgery no less than 6 months 9) No anesthesia or operation contraindication disease 10) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations 11) Negative cytological detection in operation 12) No seriously concomitance's diseases 13) Karnofsky Performance Scores (KPS) more than 60 14) Examined lymph node count no less than 16 Exclusion Criteria: 1) Women during pregnant stage and breast-feed stage 2) Women of childbearing age without any contraceptive measures 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months 4) Immunosuppressive therapists for organ transplantation 5) Seriously uncontrolled recurrent infection 6) other malignant tumors 7) No abilities of self-knowledge or mental disorders 8) Participating in other clinical trials 9) Siewert I and II esophagogastric junction tumors 10) Serious internal diseases obstruction surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group<br>The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. | Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction<br>* In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.<br>|
| Active Comparator: Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group<br>The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. | Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction<br>* In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative recovery results | Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) | Within 1 month after surgery | 
| Late postoperative recovery results | Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) | 1 year after surgery |