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

NCT ID: NCT02727153

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 765 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Colonic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Ultra" E.R.A.S.

Discharge patients on Post Operative Day 2

Group Type: EXPERIMENTAL

"Ultra" E.R.A.S.

Intervention Type: OTHER

Classic E.R.A.S.

Discharge patients on Post Operative Day 4

Group Type: ACTIVE_COMPARATOR

Classic E.R.A.S.

Intervention Type: OTHER

Interventions

"Ultra" E.R.A.S.

Intervention Type: OTHER

Classic E.R.A.S.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AUSL Romagna Rimini

OTHER

Sponsor Role: lead

Responsible Party

Luca Maria Siani

MD - Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AUSLR

Identifier Type: -

Identifier Source: org_study_id