Evaluation of the Sarcopenia in Hepatobiliary Surgery

NCT03754452 | Terminated DMC

• 1 other identifier: 2018-A1104-51
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Hepatobiliary Disease; Postoperative Complications; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia

  3 months

• comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.

  4 months

Eligibility Criteria

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

Study Population

\- all patients who should have a hepatobiliary surgery for malignant and benign tumor in the universitary hospital center of Angers

You may qualify if:

• hepatobiliary surgery
• scheduled surgery
• oral consent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Sarcopenia; Digestive System Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Julien BARBIEUX, Dr

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 27, 2018
• Study Start: November 9, 2018
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)