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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618811
• Other study ID #: JagiellonianU-03
• Status: Completed
• Phase: N/A
• First received: November 22, 2015
• Last updated: November 28, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Sarcopenia

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery, Jagiellonian University	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications		up to 30 days post surgery	Yes
Secondary	Hospital length of stay (days)		up to discharge from hospital, an average 6 days	Yes
Secondary	Compliance with ERAS protocol (%)		up to discharge from hospital, an average 6 days	Yes
Secondary	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	up to discharge from hospital, an average 6 days	Yes
Secondary	Time to first flatus		up to discharge from hospital, an average 6 days	Yes
Secondary	Readmission rate		up to 30 days post surgery	Yes
Secondary	Mobilization on the 1st postoperative day	walking at least 100 m without assistance, at least 6h out of bed (sitting, walking)	up to discharge from hospital, an average 6 days	Yes
Secondary	Need for opioid analgesia postoperatively	no need for opioid drug administration (any kind, dosage or administration route)	up to discharge from hospital, an average 6 days	Yes