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

NCT02618811 | Completed

• 1 other identifier: JagiellonianU-03
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Colonic Neoplasms

Keywords

sarcopenia; myosteatosis; enhanced recovery after surgery; colorectal cancer; minimally invasive surgery; complications

Outcome Measures

Primary Outcomes (1)

• Complications

  up to 30 days post surgery

Secondary Outcomes (7)

• 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

• Time to first flatus

  up to discharge from hospital, an average 6 days

• Readmission rate

  up to 30 days post surgery

Study Arms (4)

Group 1

not sarcopenic

Group 2

sarcopenic

Group 3

not myosteatotic

Group 4

myosteatotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University

Krakow, 31-501, Poland

Location

Related 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.

  PMID: 24368573 BACKGROUND

• 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.

  PMID: 21597360 BACKGROUND

• 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.

  PMID: 26194849 BACKGROUND

• 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.

  PMID: 25328119 BACKGROUND

• 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.

  PMID: 22695408 BACKGROUND

• 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.

  PMID: 23530101 BACKGROUND

• 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.

  PMID: 25468746 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michał Pędziwiatr, MD, PhD

  2nd Department of Surgery, Jagiellonian University, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 1, 2015

Record last verified: 2015-11

Locations

PL (1)