Evaluation of the Sarcopenia in Hepatobiliary Surgery

Terminated

• Conditions: Postoperative Complications; Sarcopenia; Hepatobiliary Disease; Surgery

• Registration Number: NCT03754452
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• hepatobiliary surgery
• scheduled surgery
• oral consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 woman: i/impedancemetry BMI\<6,42kg/m2 and ii/muscular force \< 20kg or a walking speed \<0,8m/s

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France