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

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649348
• Other study ID #: 81270449
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 2018

Study information

• Verified date: December 2018
• Source: Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Stomach Neoplasms
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of postoperative complications		up to six months