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

Primary Purpose

Colonic Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
"Ultra" E.R.A.S.
Classic E.R.A.S.
Sponsored by
AUSL Romagna Rimini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Cancer focused on measuring Colonic cancer, E.R.A.S. programs, Safety

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    "Ultra" E.R.A.S.

    Classic E.R.A.S.

    Arm Description

    Discharge patients on Post Operative Day 2

    Discharge patients on Post Operative Day 4

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Morbidity
    Reoperation rate
    Readmission rate

    Full Information

    First Posted
    March 10, 2016
    Last Updated
    April 2, 2016
    Sponsor
    AUSL Romagna Rimini
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02727153
    Brief Title
    "Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
    Official Title
    "Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer: Discharge After the First Flatus? A Prospective, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    AUSL Romagna Rimini

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Cancer
    Keywords
    Colonic cancer, E.R.A.S. programs, Safety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    765 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    "Ultra" E.R.A.S.
    Arm Type
    Experimental
    Arm Description
    Discharge patients on Post Operative Day 2
    Arm Title
    Classic E.R.A.S.
    Arm Type
    Active Comparator
    Arm Description
    Discharge patients on Post Operative Day 4
    Intervention Type
    Other
    Intervention Name(s)
    "Ultra" E.R.A.S.
    Intervention Type
    Other
    Intervention Name(s)
    Classic E.R.A.S.
    Primary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Morbidity
    Time Frame
    90 days
    Title
    Reoperation rate
    Time Frame
    90 days
    Title
    Readmission rate
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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