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Completed

NCT Number: NCT02618811

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed adenocarcinoma of colon or rectum
  • complete preoperative radiology assessment with abdominal CT scan
  • laparoscopic resection
  • perioperative care according to ERAS principles

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Complications

    Time frame: up to 30 days post surgery

Secondary outcomes

  1. Hospital length of stay (days)

    Time frame: up to discharge from hospital, an average 6 days

  2. Compliance with ERAS protocol (%)

    Time frame: up to discharge from hospital, an average 6 days

  3. Tolerance of oral diet on the 1st postoperative day

    Time frame: 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

  4. Time to first flatus

    Time frame: up to discharge from hospital, an average 6 days

  5. Readmission rate

    Time frame: up to 30 days post surgery

  6. Mobilization on the 1st postoperative day

    Time frame: up to discharge from hospital, an average 6 days

    walking at least 100 m without assistance, at least 6h out of bed (sitting, walking)

  7. Need for opioid analgesia postoperatively

    Time frame: up to discharge from hospital, an average 6 days

    no need for opioid drug administration (any kind, dosage or administration route)

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Dec 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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