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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02727153
Enrollment
765
Registered
2016-04-04
Start date
2008-01-31
Completion date
2015-12-31
Last updated
2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Cancer

Keywords

Colonic cancer, E.R.A.S. programs, Safety

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.

Interventions

OTHERUltra E.R.A.S.
OTHERClassic E.R.A.S.

Sponsors

AUSL Romagna Rimini
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mortality90 days

Secondary

MeasureTime frame
Morbidity90 days
Reoperation rate90 days
Readmission rate90 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026