Colonic Cancer Clinical Trial
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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