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OpenTrials
Completed

NCT Number: NCT02727153

"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer

Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications.

Objective. Aim of this study is to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first flatus has passed and in the absence of complication-related symptoms.

Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.

Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S.

Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality, along with surgical complications, re-operation and readmission rate were recorded and compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission and re-operation rate.

Limitations. It is a single center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may be considered arbitrary.

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Key information

About this study

From January 2008 to September 2015, 765 patients were prospectively randomized for early discharge after laparoscopic colectomy according to E.R.A.S. programs: after obtained informed consent, 384 patients were randomly assigned to the "Ultra" E.R.A.S. group and 381 to Classic E.R.A.S. group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Resectable colonic cancer

Exclusion criteria

  • metastatic patients
  • T4b tumors
  • urgent operations (because of obstruction, perforation or bleeding refractory to conservative treatment)
  • huge neoplasms (>7cm)
  • positive cytology in peritoneal lavage or frank carcinosis
  • inability to tolerate pneumoperitoneum
  • ASA class 4
  • severe portal hypertension with hepato-caval gradient >10mmHg

Treatment and study plan

"Ultra" E.R.A.S.

Other

Classic E.R.A.S.

Other

Primary outcomes

  1. Mortality

    Time frame: 90 days

Secondary outcomes

  1. Morbidity

    Time frame: 90 days

  2. Reoperation rate

    Time frame: 90 days

  3. Readmission rate

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

AUSL Romagna Rimini

Other

Registry information

Official study title

"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer: Discharge After the First Flatus? A Prospective, Randomized Trial

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2016
Registry last updated
Apr 5, 2016

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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