"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
1 other identifier
interventional
765
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedApril 5, 2016
March 1, 2016
7.9 years
March 10, 2016
April 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
90 days
Secondary Outcomes (3)
Morbidity
90 days
Reoperation rate
90 days
Readmission rate
90 days
Study Arms (2)
"Ultra" E.R.A.S.
EXPERIMENTALDischarge patients on Post Operative Day 2
Classic E.R.A.S.
ACTIVE COMPARATORDischarge patients on Post Operative Day 4
Interventions
Eligibility Criteria
You may qualify if:
- Resectable colonic cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD - Ph.D.
Study Record Dates
First Submitted
March 10, 2016
First Posted
April 4, 2016
Study Start
January 1, 2008
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 5, 2016
Record last verified: 2016-03