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

Qingdao University

Status: Completed

Conditions: Metabolic Syndrome X; Stomach Neoplasms

Treatments: Behavioral: pre-operative prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02649348

81270449

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

pre-operative prehabilitation

Other group

Description:

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.

Treatment:

Behavioral: pre-operative prehabilitation

Comparator

No Intervention group

Description:

Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.