Stomach NeoplasmsNCT02649348
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
A study testing pre-operative prehabilitation in people with Stomach Neoplasms and Metabolic Syndrome X, run by Qingdao University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Metabolic Syndrome X
- What is being tested?
- pre-operative prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266001
About this study
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
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.
Read the 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.
- Conditions
- Stomach Neoplasms, Metabolic Syndrome X
- Being tested
- pre-operative prehabilitation
- Keywords
- gastric neoplasm, metabolic syndrome, prehabilitation, pre-operative exercise, laparoscopic radical gastrectomy
- Medical subject headings
- Stomach Neoplasms, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative prehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: pre-operative prehabilitation |
| Comparator | No intervention | Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of postoperative complications
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Zhou, Qingdao University
- Investigators
- Yan Han, M.D., Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649348
- Sponsor's protocol ID
- 81270449
- Status last verified
- Dec 2018
- First submitted
- 4 Jan 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02649348
- Acronym / sponsor ID
- 81270449
- Conditions
- Stomach Neoplasms, Metabolic Syndrome X
- Keywords
- gastric neoplasm, metabolic syndrome, prehabilitation, pre-operative exercise, laparoscopic radical gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-operative prehabilitation | Other | Behavioral: pre-operative prehabilitationPatients 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. |
| Comparator | No intervention | –Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-operative prehabilitationTo 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. | Behavioural | pre-operative prehabilitation |
Primary outcome
The proportion of postoperative complications
Time frame: up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Han, M.D. study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-operative prehabilitation in people with Stomach Neoplasms and Metabolic Syndrome X, run by Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of postoperative complications (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.