Nutrition DisordersNCT03043183
Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status
A study testing perioperational nutrition surpport in people with Nutrition Disorders, run by The First Hospital of Jilin University.
Trial summary
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- perioperational nutrition surpport
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 30 Sep 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;
- age 18-75 years;
- pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
- normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease;
- no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
- PG-SGA score ≥2，<9
Who cannot join
- patients requiring conversion to open gastrectomy
- excessive bleeding (˃ 500 mL);and patients opting out of the study.
About this study
Official title: The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.
- Conditions
- Nutrition Disorders
- Being tested
- perioperational nutrition surpport
- Keywords
- gastric cancer, Enhanced recovery after surgery
- Medical subject headings
- Nutrition Disorders, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperational nutrition surpportProcedure or surgery
Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
| Study group | Role | What they receive |
|---|---|---|
| Preoperational nutrition support group | Experimental | Scored patient-generated subjective global assessment(PG-SGA) ≥2，<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation Receives: Procedure: perioperational nutrition surpport |
| Conventional group | No intervention | PG-SGA ≥2，<9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication
fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2017 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043183
- Sponsor's protocol ID
- ERAS AND Nutritional Status
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 6 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT03043183
- Acronym / sponsor ID
- ERAS AND Nutritional Status
- Conditions
- Nutrition Disorders
- Keywords
- gastric cancer, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 3 Feb 2017 (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.
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperational nutrition support group | Experimental | Procedure: perioperational nutrition surpportScored patient-generated subjective global assessment(PG-SGA) ≥2，<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation |
| Conventional group | No intervention | –PG-SGA ≥2，<9 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;
- age 18-75 years;
- pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
- normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease;
- no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
Key exclusion criteria (2 listed)
- patients requiring conversion to open gastrectomy
- excessive bleeding (˃ 500 mL);and patients opting out of the study.
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 |
|---|---|---|
| perioperational nutrition surpportOral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation | Procedure or surgery | Preoperational nutrition support group |
Primary outcome
complication
Time frame: 30 days after operation
fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing perioperational nutrition surpport in people with Nutrition Disorders, run by The First Hospital of Jilin University.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
complication (time frame: 30 days after operation). 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 6 Feb 2017.