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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Colonic Cancer

Intervention / Treatment
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* Other: Ultra E.R.A.S.
* Other: Classic E.R.A.S.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultra E.R.A.S.<br>Discharge patients on Post Operative Day 2 | Other: Ultra E.R.A.S.<br> <br> |
| Active Comparator: Classic E.R.A.S.<br>Discharge patients on Post Operative Day 4 | Other: Classic E.R.A.S.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 90 days | 
| Reoperation rate |  | 90 days | 
| Readmission rate |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic cancer, E.R.A.S. programs, Safety