Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

A Prospective Study of Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Deformity
• Intervention / Treatment: Other: Data collection

Detailed Description

Adopting the method of continuous fixed point sampling, the inpatients in the orthopedic ward of our hospital were selected as the objects of investigation.

(1) Data collection

1. general data: The information of gender, age, ethnicity, height, weight, course of disease, family history, combined diseases, medication etc.
2. Nutritional assessment：①Nutritional risk screening tool 2002(NRS 2002), an evidence-based nutritional risk screening tool developed by the European Society for Parenteral and Endoenteral Nutrition, was recommended by the Chinese Society for Parenteral and Endoenteral Nutrition as a nutritional risk screening tool for inpatients in China. The total NRS 2002 was divided into three scores, namely disease severity score, impaired nutritional status score and age score. NRS 2002 score ≥3 (accompanied by poor general conditions, such as weight loss, appetite, mental state, etc.) are at nutritional risk and require nutritional support; Those with a score less than 3 have no nutritional risk and do not need nutritional support. ②Other indicators include height, weight and body mass index, as well as biochemical indicators such as pre-albumin and hemoglobin. Nutritional assessment was performed within 24 hours of admission, on the 1d after surgery, on the 7d after surgery, every 7d after surgery, or upon discharge. NRS 2002 was repeated to assess patients' nutritional risk at the first review three months after discharge.
3. Nutritional support: The nutritional support received during the hospital was recorded, including the form of nutritional support (enteral or parenteral nutrition), energy ratio, variety selection, duration of administration, etc. 1 g carbohydrate provided 16.74 kJ(4 kcal) calories, 1 g fat milk provided 38.93 kJ(9.3 kcal) calories and 1 g amino acid provided 16.74 kJ(4 kcal) calories to calculate the energy provided by the nutritional support program. The amount of nitrogen provided by the nutritional support program was calculated with about 1 g nitrogen provided by 6.25 g amino acids.
4. Complications: Postoperative complications, such as sepsis, pneumonia, urinary tract infection, wound infection, and delayed wound healing, were recorded during hospitalization and within 3 months after discharge.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ruifeng Xu; Phone Number: +86 15011968861; Email: xuruifeng0502@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Ruifeng Xu; Phone Number: +8615011968861

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic patients with spine deformity

Description

Inclusion Criteria:

• Diagnosis of spine deformity, complete the operation in one time；
• Age: More than 10 years old ；
• Patients and their family members agreed to participate in the study and signed the informed consent；
• Conscious, patient or family members can communicate verbally.

Exclusion Criteria:

• Emergency surgery；
• Hospital stay less than 24 hours；
• Surgery was not performed during the hospital stay；
• Nutritional metabolic diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients with spine deformity undergoing surgical treatment	Other: Data collection; The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data of nutritional assessment and support	NRS2002 nutritional assessment results	Through the hospitalization, an average of 10 days.
Blood parameters about nutritional assessment and support	Hemoglobin values	Baseline
Blood parameters about nutritional assessment and support	blood hemoglobin values	Through the hospitalization after surgery, an average of 10 days.
Blood parameters about nutritional assessment and support	blood prealbumin values	Baseline
Blood parameters about nutritional assessment and support	Prealbumin values	Through the hospitalization after surgery, an average of 10 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Postoperative complication rate during hospitalization and within 3 months after discharge.	After surgery to 3-month follow-up

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Ruifeng Xu, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Spine deformity, Nutritional support, Postoperative complications
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: LM2020093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No