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

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

Official 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

Conditions
-----------------
Stomach Neoplasms, Metabolic Syndrome X

Intervention / Treatment
-----------------
* Behavioral: pre-operative prehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pre-operative prehabilitation<br>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<br>* 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.<br>|
| No Intervention: Comparator<br>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 | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of postoperative complications |  | up to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric neoplasm, metabolic syndrome, prehabilitation, pre-operative exercise, laparoscopic radical gastrectomy