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NCT Number: NCT02649348

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

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pre-operative prehabilitation

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.

Primary outcomes

  1. The proportion of postoperative complications

    Time frame: up to six months

Sponsors and collaborators

Lead sponsor

Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2016
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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