Effects of Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery

NCT04690179 | Unknown

• 1 other identifier: 1
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our surgical population and their relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence. This is a retrospective study on a prospective maintains database of complex abdominal wall surgery. We select patients with defects larger than 10 cm from any location (W3 of the EHS classification), excluding other causes of complex abdominal wall in order to have a more homogeneous sample. Pre-surgical computed tomography (CT) scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia, obesity, sarcopenia-obesity or the absence of these (normal). The CT scans will be reviewed by two trained investigators, blinded to postoperative complications and survival. In case of disagreement, a third investigator will break the tie. The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index. Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra (L3). The BMI, the Visceral Fat Area and the Subcutaneous Fat Area (SFA) will also be measured. With the previous data, the VFA / SFA ratio will be calculated. The study will be completed with the collection of sociodemographic data, comorbidities and presence of risk factors for the development of incisional hernia, ASA, size and location of the hernia, surgical technique, postoperative complications according to Clavien-Dindo, stay, readmission, late complications and hernia recurrence. Likewise, the presence or absence of recurrence will be collected. Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence. To evaluate the independent contribution of each variable to the presence of complications, a univariate and multivariate logistic regression analysis will be performed.

Conditions

Sarcopenia; Sarcopenic Obesity; Incisional Hernia

Outcome Measures

Primary Outcomes (2)

• Complications

  Presence of local or systemic complications

  Thirty postoperative day

• Recurrence

  Appearance of an incisional hernia recurrence

  Twenty four postoperative month

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

Patients undergoing complex abdominal wall surgery at the Ramón y Cajal University Hospital, at the Puerta de Hierro-Majadahona University Hospital and at the Henares University Hospital

You may qualify if:

• Patients operated for an incisional hernia with a transverse diameter greater than 10 cm measured in the preoperative Computed Tomography.

You may not qualify if:

• Not having a preoperative Computed Tomography performed in the three months before the operation.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Related Publications (19)

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MeSH Terms

Conditions

Sarcopenia; Incisional Hernia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Luis Blázquez Hernando, MD

CONTACT

+34 606986114; luisalberto.blazquez@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 30, 2020
• Study Start: January 18, 2021
• Primary Completion: August 15, 2021
• Study Completion: October 15, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share