ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

Colonic Neoplasms Clinical Trial

Official title:

Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527967
• Other study ID #: JagiellonianU-02
• Status: Completed
• Phase: N/A
• First received: August 13, 2015
• Last updated: August 17, 2015
• Start date: January 2013
• Est. completion date: February 2015

Study information

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

Clinical Trial Summary

Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.

Description:

All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.

Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.

For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• colorectal cancer

• laparoscopic resection

• perioperative care according to ERAS principles

Exclusion Criteria:

• Patients submitted initially for open or emergency surgery

• with complex cancer who required multi-organ resection

• patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Laparoscopy
• Perioperative Care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(®)) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. — View Citation

Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay (days)		participants will be followed for the duration of hospital stay, an expected average of 4 days	Yes
Secondary	Compliance with ERAS protocol (%)	Compliance (%) will be calculated as the number of pre and intraoperative interventions fulfilled/13*100% (number of pre- and intraoperative protocol elements included into compliance calculations)	participants will be followed for the duration of hospital stay, an expected average of 4 days	Yes
Secondary	Complication rate (%)		up to 30 days post surgery	Yes
Secondary	Readmission rate (%)		up to 30 days post surgery	Yes