Nutrition AssessmentPNASNCT03115931
The Effect of Perioperative Nutritional Assessment and Nutritional Support on Clinical Outcomes
An observational study of Nutrition Assessment and Nutritional Support, run by Jinling Hospital, China at 1 site in China.
Trial summary
It is a study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Assessment, Nutritional Support, Clinical Outcomes
- How many people
- 4,880 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2017to 26 Nov 2025
- Phase
- Observational
- 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
Study population: Patients undergoing selective operation without trauma.
Who may be able to join
- Informed consent of patients or their legal representatives to participate in this study.
- patients undergoing selective operation without trauma
Who cannot join
- Age: <18 years old or >80 years old
- Discharge within 24 hours
- Accept surgery at 8:00 next day
- Withdraw of patient's informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Nutritional Assessment and Nutritional Support on Clinical Outcomes in Elective Abdominal Surgery Patients: A Prospective Observational Study
It is a study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation.
Read the detailed description
It is a multi-center prospective observational cohort study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation. The nutrition risk were evaluated by different methods. The nutrition support regimens and the clinical outcomes were recorded.
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity of infection
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
Measured: From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.
Secondary outcomes (5)
Resting Energy Expenditure (REE) by Indirect Calorimetry
REE was measured by indirect calorimetry (Q-NRG®) on postoperative days 1, 3, and 5 under standardized fasting and resting conditions.
Measured: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Nutrition indicator
albumin/prealbumin/transferrin/retinol binding protein/IL-6
Measured: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Length of stay in hospital
The length of patients stay in hospital.
Measured: From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.
Actual calories intake
The total energy patients received during the study
Measured: From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.
Mortality
All deaths reported in all enrolled patients.
Measured: From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start14 Nov 2017
- Primary completion30 Jun 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nutrition AssessmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xijing Hospital, West China Hospital, Xinqiao Hospital of Chongqing, Second Affiliated Hospital, Zhejiang University, School of Medicine, Changhai Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, Wang Xinying, Jinling Hospital, China
- Investigators
- Xinying Wang, PhD, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115931
- Sponsor's protocol ID
- 201502022-1
- Acronym
- PNAS
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2017
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine); Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.
PubMed 16698152Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.
PubMed 11680474Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. No abstract available.
PubMed 4965871Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21.
PubMed 19464088American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):255-9. doi: 10.1177/0148607109333115. No abstract available.
PubMed 19398611Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
PubMed 23689848
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Nutritional Assessment and Nutritional Support on Clinical Outcomes in Elective Abdominal Surgery Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03115931
- Acronym / sponsor ID
- PNAS / 201502022-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,880 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Xijing Hospital, West China Hospital, Xinqiao Hospital of Chongqing, Second Affiliated Hospital, Zhejiang University, School of Medicine, Changhai Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The Affiliated Hospital of Qingdao University, First Affiliated Hospital of Kunming Medical University
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
It is a study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation.
Detailed description
It is a multi-center prospective observational cohort study to evaluate the relationship between preoperative nutritional assessment and clinical outcomes and to explore the effect of preoperative nutritional support on clinical outcomes in patients after abdominal operation. The nutrition risk were evaluated by different methods. The nutrition support regimens and the clinical outcomes were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing selective operation without trauma.
Key inclusion criteria (2 listed)
- Informed consent of patients or their legal representatives to participate in this study.
- patients undergoing selective operation without trauma
Key exclusion criteria (4 listed)
- Age: <18 years old or >80 years old
- Discharge within 24 hours
- Accept surgery at 8:00 next day
- Withdraw of patient's informed consent
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Morbidity of infection
Time frame: From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.
Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.
5 secondary outcomes
Resting Energy Expenditure (REE) by Indirect Calorimetry
Time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Nutrition indicator
Time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Length of stay in hospital
Time frame: From date of patients enrollment until the date of patients discharged from hospital, assessed up to 12 months.
Actual calories intake
Time frame: From date of patients enrollment until the date of patients are subjected to operation, assessed up to 2 months.
Mortality
Time frame: From date of patients enrollment until the date of death from any cause, assessed up to 2 months after patients discharged from hospital.
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 13 Aug 2026.
- Background: PubMed 16698152Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine); Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.
- Background: PubMed 11680474Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.
- Background: PubMed 4965871Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. No abstract available.
- Background: PubMed 19464088Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN. ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21.
- Background: PubMed 19398611American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):255-9. doi: 10.1177/0148607109333115. No abstract available.
- Background: PubMed 23689848Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
- 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.
Xinying Wang, PhD principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Assessment and Nutritional Support, run by Jinling Hospital, China 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 2 inclusion and 4 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 13 Aug 2026. 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?
Morbidity of infection (time frame: From date of patients enrollment until the date of infection documented from any cause, assessed up to 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115931, which also lists 6 linked publications.
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 13 Aug 2026.