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

Not Applicable

Completed

• Conditions: Stomach Neoplasms; Metabolic Syndrome X
• Interventions: Behavioral: pre-operative prehabilitation

• Registration Number: NCT02649348
• Lead Sponsor: Qingdao University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-operative prehabilitation	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.

Primary Outcome Measures

Name	Time	Method
The proportion of postoperative complications	up to six months

Trial Locations

Locations (1)

the Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China