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

Colonic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727153
• Other study ID #: AUSLR
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2016
• Last updated: April 2, 2016
• Start date: January 2008
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: AUSL Romagna Rimini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Cancer

Intervention

Other:
• "Ultra" E.R.A.S.

• Classic E.R.A.S.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AUSL Romagna Rimini

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		90 days	Yes
Secondary	Morbidity		90 days	Yes
Secondary	Reoperation rate		90 days	Yes
Secondary	Readmission rate		90 days	Yes