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

Phase 3

Completed

• Conditions: Colonic Cancer
• Interventions: Other: "Ultra" E.R.A.S.; Other: Classic E.R.A.S.

• Registration Number: NCT02727153
• Lead Sponsor: AUSL Romagna Rimini

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 Description

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-04-02
• Study First Posted: 2016-04-04
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 765

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Ultra" E.R.A.S.	"Ultra" E.R.A.S.	Discharge patients on Post Operative Day 2
Classic E.R.A.S.	Classic E.R.A.S.	Discharge patients on Post Operative Day 4

Primary Outcome Measures

Name	Time	Method
Mortality	90 days

Secondary Outcome Measures

Name	Time	Method
Morbidity	90 days
Reoperation rate	90 days
Readmission rate	90 days