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Clinical Trials/NCT02527967
NCT02527967
Completed
Not Applicable

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

Jagiellonian University1 site in 1 country143 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Neoplasms
Sponsor
Jagiellonian University
Enrollment
143
Locations
1
Primary Endpoint
Hospital length of stay (days)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jagiellonian University
Responsible Party
Principal Investigator
Principal Investigator

Michał Pędziwiatr

Michał Pędziwiatr, MD PhD

Jagiellonian University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Hospital length of stay (days)

Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcomes

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

Study Sites (1)

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