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

NCT02649348 | Completed DMC

• 1 other identifier: 81270449
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms; Metabolic Syndrome X

Keywords

gastric neoplasm; metabolic syndrome; prehabilitation; pre-operative exercise; laparoscopic radical gastrectomy

Outcome Measures

Primary Outcomes (1)

• The proportion of postoperative complications

  up to six months

Study Arms (2)

pre-operative prehabilitation

OTHER

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

Comparator

NO INTERVENTION

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

Interventions

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.

pre-operative prehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Metabolic Syndrome

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yan Han, M.D.

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 7, 2016
• Study Start: September 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)