Evaluation of the Sarcopenia in Hepatobiliary Surgery

Surgery Clinical Trial

— SARFO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03754452
• Other study ID #: 2018-A1104-51
• Status: Terminated
• Start date: November 9, 2018
• Est. completion date: September 7, 2021

Study information

• Verified date: January 2024
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hepatobiliary surgery
• scheduled surgery
• oral consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Hepatobiliary Disease
• Liver Diseases
• Postoperative Complications
• Sarcopenia
• Surgery

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking	for the man : i/impedancemetry BMI<8,87kg/m2 and ii/ a muscular force < 30kg or a walking speed <0,8m/s	1 month
Primary	the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking	for the woman: i/impedancemetry BMI<6,42kg/m2 and ii/muscular force < 20kg or a walking speed <0,8m/s	1 month
Secondary	comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia	impedancemetry used to evaluate the muscular mass; abdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section	3 months
Secondary	comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.	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	4 months