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Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome

NCT ID: NCT02649348

Last Updated: 2018-12-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-02-28

Brief Summary

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A prospective randomised controlled trial to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Detailed Description

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To investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.

Conditions

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Stomach Neoplasms Metabolic Syndrome X

Keywords

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gastric neoplasm metabolic syndrome prehabilitation pre-operative exercise laparoscopic radical gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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pre-operative prehabilitation

Patients in the pre-operative prehabilitation group required the exercise intervention protocol, which included climbing six flights of stairs at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction following abdominal surgery by using a full elastic breathable abdominal bandage.

Group Type OTHER

pre-operative prehabilitation

Intervention Type BEHAVIORAL

To climb six flights of stairs (approximately 20 meters in height) at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction (increased thoracic and decreased abdominal breathing compliance) following abdominal surgery by using a full elastic breathable abdominal bandage.

Comparator

Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pre-operative prehabilitation

To climb six flights of stairs (approximately 20 meters in height) at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction (increased thoracic and decreased abdominal breathing compliance) following abdominal surgery by using a full elastic breathable abdominal bandage.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* histologically-proven pre-operative stage I-III gastric cancer
* Combined with metabolic syndrome
* Age limits from 18 to 80 years old
* Classified into American Society of Anesthesiology (ASA) II or III surgical risk
* no history of abdominal surgery on organs located at the abdominal supramesocolic level

Exclusion Criteria

* Combined with severe cardiac or pulmonary disease or other organ dysfunction
* ASA IV
* The history of abdominal surgery
* Conversion to open surgery
* The presence of gastrointestinal obstruction, perforation or necrosis;
* Declined to participate in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Yanbing Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Han, M.D.

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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81270449

Identifier Type: -

Identifier Source: org_study_id