Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

NCT04968483 | Unknown DMC

• 1 other identifier: LM2020093
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine Deformity

Keywords

Spine deformity, Nutritional support, Postoperative complications

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Complication rate

  After surgery to 3-month follow-up

Study Arms (1)

Study group

Patients with spine deformity undergoing surgical treatment

Other: Data collection

Interventions

Data collection OTHER

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

Study group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic patients with spine deformity

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ruifeng Xu

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruifeng Xu

CONTACT

+86 15011968861; xuruifeng0502@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 20, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 30, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)