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Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy

NCT ID: NCT01697943

Last Updated: 2012-10-16

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

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.

Detailed Description

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Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down.

Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed.

This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.

Conditions

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Gastric Tumor

Keywords

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Gastric Malignant Tumor Total Gastrectomy Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction

Group Type EXPERIMENTAL

Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Intervention Type PROCEDURE

Interventions

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Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.

* Patients 20-75 years old
* Normal organ function, able to tolerate surgery, no clear contraindication for surgery
* No evidence of metastases of adjacent organs
* be able to provide follow-up over 2 years
* No specific treatment for gastric cancer before surgery
* In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
* The subjects were able to understand and comply with the trial protocol, and signed informed consent.

Exclusion Criteria

* • Synchronous or metachronous (less than five years) and with other malignancies.

* Cirrhosis and portal hypertension
* Associated with blood diseases
* Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
* Suffering from a serious neurological diseases or psychological diseases affecting the life
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Yanong Wang

Director of Department of Abdominal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ya Nong Wang, MD,PhD

Role: CONTACT

Phone: +86-21 64175590

Email: [email protected]

Hua Huang, MD,PhD

Role: CONTACT

Phone: +86-21 64175590

Email: [email protected]

Facility Contacts

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Ya Nong Wang, MD,PhD

Role: primary

Hua Huang, MD,PhD

Role: backup

Other Identifiers

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2012-44-563

Identifier Type: -

Identifier Source: org_study_id