Gastric Cancer, Peristaltic Direction, Roux-en-Y Gastrointestinal Anastomosis
Conditions
Brief summary
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
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.
Interventions
PROCEDUREDirection procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative recovery results | Within 1 month after surgery | Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) |
| Late postoperative recovery results | 1 year after surgery | Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Within 1 month after surgery | Postoperative incision infection, anastomotic leakage, intestinal obstruction, reoperation and readmission, etc |
Countries
China
Contacts
Primary ContactJingyu Deng, M.D.
Backup ContactHan Liang, M.D.
Outcome results
None listed