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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02649348
Other study ID # 81270449
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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