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

August 17, 2015 updated by: Michał Pędziwiatr, Jagiellonian University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kraków, Poland, 31-501
        • 2nd Department of General Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2013-2014. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1 (≤4 days)
Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).
Group 1 (>4 days)
In group 2 were patients whose hospital stay was longer than 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay (days)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Michał Pędziwiatr, MD, PhD, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JagiellonianU-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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