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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: AUSL Romagna Rimini

Current Primary Outcome: Mortality [ Time Frame: 90 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Morbidity [ Time Frame: 90 days ]
  • Reoperation rate [ Time Frame: 90 days ]
  • Readmission rate [ Time Frame: 90 days ]


Original Secondary Outcome: Same as current

Information By: AUSL Romagna Rimini

Dates:
Date Received: March 10, 2016
Date Started: January 2008
Date Completion:
Last Updated: April 2, 2016
Last Verified: March 2016