MalnourishedNCT01421680
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients
A study testing Ensure powder in people with Malnourished and Stomach Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malnourished, Stomach Neoplasms, Gastrointestinal Stromal Tumors
- What is being tested?
- Ensure powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 20 years
- Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
- Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
- Patients who can take oral meals
- Patients who agree on the informed consent
Who cannot join
- Emergent operation
- Patients who received preoperative chemotherapy or radiation therapy within 6 months
- Pregnant patients
- Patients who cannot consume the Ensure powder
- Patients who enrolled another clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.
- Being tested
- Ensure powder
- Medical subject headings
- Malnutrition, Stomach Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure powderDietary supplement
Also called Ensure powder (Abbott)
Ensure powder(500kcal) per day for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ensure powder | Active comparator | Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals Receives: Dietary Supplement: Ensure powder |
| Standard care | No intervention | Standard care without oral nutritional supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Measured: 7weeks
Secondary outcomes (8)
Body weight
Measured: 7weeks
Body composition indices
Measured: 7weeks
Length of hospital stay
Measured: 7weeks
Quality of life
Measured: 7weeks
Postoperative 30-day mortality
Measured: 7weeks
Biochemical assessment of nutritional status
Measured: 7weeks
Readmission rate
Measured: 7weeks
Patient compliance of oral nutritional supplements
Measured: 7weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnourishedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Han-Kwang Yang, Seoul National University Hospital
- Investigators
- Han-Kwang Yang, M.D., Principal investigator, Department of Surgery, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421680
- Sponsor's protocol ID
- ANSK1101
- Status last verified
- Mar 2014
- First submitted
- 17 Aug 2011
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
- ClinicalTrials.gov ID
- NCT01421680
- Acronym / sponsor ID
- ANSK1101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Aug 2011 (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.
The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensure powder | Active comparator | Dietary Supplement: Ensure powderOral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals |
| Standard care | No intervention | –Standard care without oral nutritional supplements |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 20 years
- Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
- Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
- Patients who can take oral meals
- Patients who agree on the informed consent
Key exclusion criteria (5 listed)
- Emergent operation
- Patients who received preoperative chemotherapy or radiation therapy within 6 months
- Pregnant patients
- Patients who cannot consume the Ensure powder
- Patients who enrolled another clinical trials
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 |
|---|---|---|
| Ensure powderAlso: Ensure powder (Abbott)Ensure powder(500kcal) per day for 7 weeks | Dietary supplement | Ensure powder |
Primary outcome
Postoperative complication rate
Time frame: 7weeks
8 secondary outcomes
Body weight
Time frame: 7weeks
Body composition indices
Time frame: 7weeks
Length of hospital stay
Time frame: 7weeks
Quality of life
Time frame: 7weeks
Postoperative 30-day mortality
Time frame: 7weeks
Biochemical assessment of nutritional status
Time frame: 7weeks
Readmission rate
Time frame: 7weeks
Patient compliance of oral nutritional supplements
Time frame: 7weeks
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 14 Mar 2014.
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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.
Han-Kwang Yang, M.D. principal investigator
Department of Surgery, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure powder in people with Malnourished and Stomach Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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 14 Mar 2014. 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 South Korea. 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?
Postoperative complication rate (time frame: 7weeks). 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 14 Mar 2014.