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

Completed

• Conditions: Laparoscopy; Perioperative Care; Colonic Neoplasms

• Registration Number: NCT02527967
• Lead Sponsor: Jagiellonian University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Status Verified: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-17
• Last Update Submitted: 2015-08-17
• Study First Posted: 2015-08-19
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital length of stay (days)	participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Name	Time	Method
Compliance with ERAS protocol (%)	participants will be followed for the duration of hospital stay, an expected average of 4 days	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)
Complication rate (%)	up to 30 days post surgery
Readmission rate (%)	up to 30 days post surgery

Trial Locations

Locations (1)

2nd Department of General Surgery; 🇵🇱 Kraków, Poland