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SarcopeniaNCT02618811

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

An observational study of Sarcopenia and Colonic Neoplasms, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcopenia, Colonic Neoplasms
How many people
171 participants
Where
1 sitePoland
Study dates
Jan 2014to Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • 2nd Department of General Surgery, Jagiellonian University

    Krakow, 31-501

Other trials in Poland

About this study

Official title: Enhanced Recovery After Surgery Protocol (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.

Read the 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.

Keywords
sarcopenia, myosteatosis, enhanced recovery after surgery, colorectal cancer, minimally invasive surgery, complications
Medical subject headings
Sarcopenia, Colonic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02618811
Study groupRoleWhat they receive
Group 1not sarcopenic
Group 2sarcopenic
Group 3not myosteatotic
Group 4myosteatotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complications

    Measured: up to 30 days post surgery

Secondary outcomes (7)

  1. Hospital length of stay (days)

    Measured: up to discharge from hospital, an average 6 days

  2. Compliance with ERAS protocol (%)

    Measured: up to discharge from hospital, an average 6 days

  3. 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

    Measured: up to discharge from hospital, an average 6 days

  4. Time to first flatus

    Measured: up to discharge from hospital, an average 6 days

  5. Readmission rate

    Measured: up to 30 days post surgery

  6. Mobilization on the 1st postoperative day

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

    Measured: up to discharge from hospital, an average 6 days

  7. Need for opioid analgesia postoperatively

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

    Measured: up to discharge from hospital, an average 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02618811
Sponsor's protocol ID
JagiellonianU-03
Status last verified
Nov 2015
First submitted
22 Nov 2015
Last updated
1 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.

    PubMed 24368573

  • Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

    PubMed 21597360

  • Huang DD, Wang SL, Zhuang CL, Zheng BS, Lu JX, Chen FF, Zhou CJ, Shen X, Yu Z. Sarcopenia, as defined by low muscle mass, strength and physical performance, predicts complications after surgery for colorectal cancer. Colorectal Dis. 2015 Nov;17(11):O256-64. doi: 10.1111/codi.13067.

    PubMed 26194849

  • Jones KI, Doleman B, Scott S, Lund JN, Williams JP. Simple psoas cross-sectional area measurement is a quick and easy method to assess sarcopenia and predicts major surgical complications. Colorectal Dis. 2015 Jan;17(1):O20-6. doi: 10.1111/codi.12805.

    PubMed 25328119

  • Thoresen L, Frykholm G, Lydersen S, Ulveland H, Baracos V, Prado CM, Birdsell L, Falkmer U. Nutritional status, cachexia and survival in patients with advanced colorectal carcinoma. Different assessment criteria for nutritional status provide unequal results. Clin Nutr. 2013 Feb;32(1):65-72. doi: 10.1016/j.clnu.2012.05.009. Epub 2012 Jun 12.

    PubMed 22695408

  • Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.

    PubMed 23530101

  • Malietzis G, Aziz O, Bagnall NM, Johns N, Fearon KC, Jenkins JT. The role of body composition evaluation by computerized tomography in determining colorectal cancer treatment outcomes: a systematic review. Eur J Surg Oncol. 2015 Feb;41(2):186-96. doi: 10.1016/j.ejso.2014.10.056. Epub 2014 Nov 3.

    PubMed 25468746

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Colonic Neoplasms, run by Jagiellonian University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications (time frame: up to 30 days post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02618811, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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