NCT Number: NCT02727153
"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Classic E.R.A.S.
OtherPrimary outcomes
-
Mortality
Time frame: 90 days
Secondary outcomes
-
Morbidity
Time frame: 90 days
-
Reoperation rate
Time frame: 90 days
-
Readmission rate
Time frame: 90 days
Sponsors and collaborators
Lead sponsor
AUSL Romagna Rimini
Other
Registry information
Official study title
"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer: Discharge After the First Flatus? A Prospective, Randomized Trial
Important dates
- Study start
- 2008
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 4, 2016
- Registry last updated
- Apr 5, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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