Evaluation of the Sarcopenia in Hepatobiliary Surgery

Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03754452

Acronym

SARFO

Enrollment

Registered

2018-11-27

Start date

2018-11-09

Completion date

2021-09-07

Last updated

2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatobiliary Disease, Postoperative Complications, Sarcopenia, Surgery

Brief summary

The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* hepatobiliary surgery * scheduled surgery * oral consent

Exclusion criteria

* pregnancy * patient under low protection * emergency surgery * hepatic encephalopathy stage II, III and IV

Design outcomes

Primary

Measure	Time frame	Description
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking	1 month	for the man : i/impedancemetry BMI\<8,87kg/m2 and ii/ a muscular force \< 30kg or a walking speed \<0,8m/s

Secondary

Measure	Time frame	Description
comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia	3 months	* impedancemetry used to evaluate the muscular mass * abdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section
comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.	4 months	postoperatives complications evualuated according the clavien dindo classification are : death, nausea, vomit, need of nasogastric tube, liver failure with jaundice, ascites, liver encephalopathy, biliary fistula, biliary peritonitis, hernia, parietal abcess, urinary infection, urinary retention, hematoma, pulmonary embolism, pulmonary infection, pleural effusion, atelectasis, renal failure, hyponatremia, hypernatremia, hypokaliema, hyperkaliema the post operative complication evaluate

Countries

France

Outcome results