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OpenTrials
Completed

NCT Number: NCT02527967

ERAS 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of General Surgery

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. 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)

  2. Complication rate (%)

    Time frame: up to 30 days post surgery

  3. Readmission rate (%)

    Time frame: up to 30 days post surgery

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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