Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

NCT ID: NCT04968483

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-03-30

Brief Summary

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

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.

Conditions

Spine Deformity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Patients with spine deformity undergoing surgical treatment

Data collection

Intervention Type: OTHER

The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.

Interventions

Data collection

The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruifeng Xu

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Ruifeng Xu

Role: CONTACT

xuruifeng0502@sina.com

+86 15011968861

Facility Contacts

Ruifeng Xu

Role: primary

+8615011968861

Other Identifiers

LM2020093

Identifier Type: -

Identifier Source: org_study_id