Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
NCT ID: NCT04801459
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
148 participants
INTERVENTIONAL
2021-04-02
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent.
Direction 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.
Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
Direction 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.
Interventions
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Direction 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Cancer Hospital of Tianjin Medical University
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Jingyu Deng, M.D.
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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DJY002
Identifier Type: -
Identifier Source: org_study_id
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