"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: "Ultra" E.R.A.S. Discharge patients on Post Operative Day 2 |
Other: "Ultra" E.R.A.S.
|
| Active Comparator: Classic E.R.A.S. Discharge patients on Post Operative Day 4 |
Other: Classic E.R.A.S.
|
Outcome Measures
Primary Outcome Measures
- Mortality [90 days]
Secondary Outcome Measures
- Morbidity [90 days]
- Reoperation rate [90 days]
- Readmission rate [90 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AUSL Romagna Rimini
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AUSLR