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

NCT ID: NCT04801459

Last Updated: 2022-03-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2024-03-31

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.

Conditions

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Peristaltic Direction Roux-en-Y Gastrointestinal Anastomosis Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Hospital of Tianjin Medical University

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingyu Deng, M.D.

Role: CONTACT

+86-22-23340123

Han Liang, M.D.

Role: CONTACT

+86-22-23340123

Facility Contacts

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Jingyu Deng, M.D.

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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DJY002

Identifier Type: -

Identifier Source: org_study_id

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