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

December 17, 2018 updated by: Yanbing Zhou, Qingdao University

Effects of Pre-operative Prehabilitation on the Clinical Outcomes of Gastric Cancer Patients With Metabolic Syndrome Who Undergo Laparoscopic Radical Gastrectomies: A Polit Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266001
        • The affiliated hospital of Qingdao university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Behavioral: 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.
No Intervention: Comparator
Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of postoperative complications
Time Frame: up to six months
up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao University

Investigators

  • Study Director: Yan Han, M.D., The affiliated hospital of Qingdao university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81270449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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