ERAS in Colorectal Surgery Diminishes the Negative Impact of Sarcopenia on Short Term Outcomes
- Conditions
- SarcopeniaColonic Neoplasms
- Registration Number
- NCT02618811
- Lead Sponsor
- Jagiellonian University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- confirmed adenocarcinoma of colon or rectum
- complete preoperative radiology assessment with abdominal CT scan
- laparoscopic resection
- perioperative care according to ERAS principles
- unavailability of a preoperative abdominal CT scan (within 30 days prior surgery)
- emergency or initially open surgery
- patients treated with endoscopic techniques: transanal endoscopic microsurgery (TEM), transanal total mesorectal excision (TaTME)
- concomitant inflammatory bowel diseases.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complications up to 30 days post surgery
- Secondary Outcome Measures
Name Time Method Mobilization on the 1st postoperative day up to discharge from hospital, an average 6 days walking at least 100 m without assistance, at least 6h out of bed (sitting, walking)
Need for opioid analgesia postoperatively up to discharge from hospital, an average 6 days no need for opioid drug administration (any kind, dosage or administration route)
Hospital length of stay (days) up to discharge from hospital, an average 6 days Compliance with ERAS protocol (%) up to discharge from hospital, an average 6 days Tolerance of oral diet on the 1st postoperative day up to discharge from hospital, an average 6 days tolerating at least 800 ml of clear water/fluids and 1 oral nutritional supplement within the first 24h postoperative hours
Time to first flatus up to discharge from hospital, an average 6 days Readmission rate up to 30 days post surgery
Trial Locations
- Locations (1)
2nd Department of General Surgery, Jagiellonian University
🇵🇱Kraków, Poland