NCT02527967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

August 13, 2015

Last Update Submit

August 17, 2015

Conditions

Colonic NeoplasmsLaparoscopyPerioperative Care

Keywords

colorectal cancerenhanced recovery after surgeryperioperative carefast-track surgerylaparoscopyminimally invasive surgerycomplications

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay (days)

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

Secondary Outcomes (3)

  • 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 Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • colorectal cancer
  • laparoscopic resection
  • perioperative care according to ERAS principles

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Department of General Surgery

Krakow, 31-501, Poland

Location

Related 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((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

    PMID: 23052794BACKGROUND

  • 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(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.

    PMID: 23062720BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Michał Pędziwiatr, MD, PhD

    2nd Department of Surgery, Jagiellonian University, Krakow, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michał Pędziwiatr, MD PhD

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 19, 2015

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

PL(1)