Back to resultsEffects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
Primary Purpose
Stomach Neoplasms, Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pre-operative prehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Stomach Neoplasms focused on measuring gastric neoplasm, metabolic syndrome, prehabilitation, pre-operative exercise, laparoscopic radical gastrectomy
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
Sites / Locations
- the Affiliated Hospital of Qingdao University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
pre-operative prehabilitation
Comparator
Arm 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.
Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.
Outcomes
Primary Outcome Measures
The proportion of postoperative complications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02649348
Brief Title
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Metabolic Syndrome X
Keywords
gastric neoplasm, metabolic syndrome, prehabilitation, pre-operative exercise, laparoscopic radical gastrectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-operative prehabilitation
Arm Type
Other
Arm 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.
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.
Intervention Type
Behavioral
Intervention Name(s)
pre-operative prehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of postoperative complications
Time Frame
up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Han, M.D.
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
the Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
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