An observational study in Sarcopenia and Colonic Neoplasms, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-01.
Sponsored by Jagiellonian University · Observational
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.
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.
1,242 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's enrollment of 171 is above the median of 120 across 433 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →Jagiellonian University is the lead sponsor of 160 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2014-2015. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
not sarcopenic
sarcopenic
not myosteatotic
myosteatotic
Complications
Time frame: up to 30 days post surgery
Hospital length of stay (days)
Time frame: up to discharge from hospital, an average 6 days
Compliance with ERAS protocol (%)
Time frame: up to discharge from hospital, an average 6 days
Tolerance of oral diet on the 1st postoperative day
tolerating at least 800 ml of clear water/fluids and 1 oral nutritional supplement within the first 24h postoperative hours
Time frame: up to discharge from hospital, an average 6 days
Time to first flatus
Time frame: up to discharge from hospital, an average 6 days
Readmission rate
Time frame: up to 30 days post surgery
Mobilization on the 1st postoperative day
walking at least 100 m without assistance, at least 6h out of bed (sitting, walking)
Time frame: up to discharge from hospital, an average 6 days
Need for opioid analgesia postoperatively
no need for opioid drug administration (any kind, dosage or administration route)
Time frame: up to discharge from hospital, an average 6 days
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.