ERAS in Colorectal Surgery Diminishes the Negative Impact of Sarcopenia on Short Term Outcomes
NCT ID: NCT02618811
Last Updated: 2015-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
171 participants
OBSERVATIONAL
2014-01-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
not sarcopenic
No interventions assigned to this group
Group 2
sarcopenic
No interventions assigned to this group
Group 3
not myosteatotic
No interventions assigned to this group
Group 4
myosteatotic
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* complete preoperative radiology assessment with abdominal CT scan
* laparoscopic resection
* perioperative care according to ERAS principles
Exclusion Criteria
* emergency or initially open surgery
* patients treated with endoscopic techniques: transanal endoscopic microsurgery (TEM), transanal total mesorectal excision (TaTME)
* concomitant inflammatory bowel diseases.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jagiellonian University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michał Pędziwiatr
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michał Pędziwiatr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Surgery, Jagiellonian University, Krakow, Poland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
2nd Department of General Surgery, Jagiellonian University
Krakow, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JagiellonianU-03
Identifier Type: -
Identifier Source: org_study_id