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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05088304
Other study ID # JinlingHospital-1
Secondary ID 201502022
Status Completed
Phase
First received
Last updated
Start date September 1, 2015
Est. completion date July 1, 2018

Study information

Verified date October 2021
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.


Description:

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied. Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date July 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002=3; Preoperative BIA examination was performed. Exclusion Criteria: Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin>3mg/dL) ; Renal insufficiency (serum creatinine>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.

Study Design


Intervention

Other:
no intervention


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Jinling Hospital, China Jiangsu Cancer Institute & Hospital, Peking Union Medical College, Subei People's Hospital of Jiangsu Province

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative complications postoperative complications (infectious complications and noninfectious complications) Within 60 days after surgery
Secondary length of stay (LOS) length of stay (LOS) Within 60 days after surgery
Secondary wound healing time wound healing time Within 60 days after surgery
Secondary postoperative antibiotic time postoperative antibiotic time Within 60 days after surgery
Secondary nutritional status nutritional status ( such as: weight,albumin,prealbumin) up to 4 weeks
Secondary hospitalization cost hospitalization cost(including: surgery and medicine costs) Within 60 days after surgery
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