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CompletedNCT02618811

ERAS in Colorectal Surgery Diminishes the Negative Impact of Sarcopenia on Short Term Outcomes

Enhanced Recovery After Surgery Protocol (ERAS) in Colorectal Surgery Diminishes the Negative Impact of Sarcopenia on Short Term Outcomes

Status
Completed
Phase
Study type
Observational
Enrollment
171 (actual)
Sponsor
Jagiellonian University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

So far, the impact of sarcopenia has been analysed only in patients undergoing traditional surgical procedures (laparotomy) or those with metastatic spread. As the ERAS protocol combined with minimally invasive access decreases postoperative metabolic disorders, it seems possible that it can limit the deleterious impact of sarcopenia as well. The aim of this study was to investigate whether the use of ERAS protocol in colorectal cancer patients influences the postoperative risk due to sarcopenia.

Detailed description

The prospective observation with post-hoc analysis of 171 consecutive colorectal cancer patients was performed. In all patients 16-item ERAS protocol was applied. Contrast-enhanced CT scan was performed preoperatively. From each scan one CT image at the level of L3 vertebra was transferred in Digital Imaging and Communications in Medicine format (DICOM) and anonymised. Firstly, the threshold range between -29 and +150 Hounsfield units was set to semi-automatically outline muscle areas, - 150 to - 50 was used for visceral adipose tissue areas, and -190 to -30 was used for subcutaneous and intermuscular adipose tissue areas. Secondly, the software calculated the surface area (cm2) of each tissue. The L3 skeletal muscle area (rectus abdominis, external and internal obliques, transversus abdominis, quadratus lumborum, psoas, erector spinae) normalized for patient height was used to calculate skeletal muscle index (SMI) (cm2/m2). According to Martin et al. sarcopenia was defined as a SMI \<41 cm2/m2 in women, \<43 cm2/m2 in men with a BMI \<25 kg/m2, and \<53 cm2/m2 in men with a BMI \>25 kg/m2 (10). To assess for myosteatosis the mean radiodensity of a L3 psoas muscle was measured. The cut-off for patients with BMI \<25 kg/m2 was \<41 Hounsfield units and \<33 Hounsfield units for patients with BMI ≥25 kg/m2. For the purposes of further analysis the entire group of patients was divided into subgroups depending on the presence of sarcopenia or myosteatosis.

Conditions

Timeline

Start date
2014-01-01
Primary completion
2015-10-01
Completion
2015-11-01
First posted
2015-12-01
Last updated
2015-12-01

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02618811. Inclusion in this directory is not an endorsement.