ERAS Lazio Network Clinical Registry

NCT03353311 | Completed

• 1 other identifier: FPAG001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal. The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients. Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Conditions

Colon Cancer; Diverticulum, Colon

Keywords

ERAS; Fast-track; colorectal surgery; immuno-nutrition

Outcome Measures

Primary Outcomes (1)

• Adherance to ERAS protocol

  Number of items included in the ERAS protocols that were applied in each centre

  36 months

Secondary Outcomes (1)

• Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay

  36 months

Study Arms (1)

Enhanced Recovery After Surgery

Patients undergoing elective colorectal surgical resection for benign/malignant disease. A multidisciplinary validated approach based on 24 items including Preadmission information, education and counselling Preoperative optimization (increasing exercise, stop smoking and alcohol consumption should 4 weeks before surgery) No preoperative bowel preparation Use of preoperative carbohydrate drinks Pre-anesthetic medication Prophylaxis against thromboembolism Antimicrobial prophylaxis and skin preparation Standard anesthetic protocol for rapid awakening PONV Mini-invasive surgery No nasogastric dreinage Prevention of intraoperative hypothermia Perioperative fluid management No drains in the peritoneal cavity after colonic anastomosis Early remouval of urinary drainage (24-48 hrs) Prevention of postoperative ileus (including use of postoperative laxatives) Postoperative analgesia Perioperative nutritional care Postoperative control of glucose Early mobilization Auditing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Open or laparoscopic colorectal surgical resection for a benign/malignant disease independently from patients age or sex

You may qualify if:

• Elective colorectal surgical resection
• Open and Laparoscopic Suregry
• Benign/malignant disease
• independently from age, sex,

You may not qualify if:

• Emergency colorectal resections

Sponsors & Collaborators

• PERSIANI ROBERTO: lead
• Azienda Ospedaliera "Sant'Andrea": collaborator
• Policlinico Casilino ASL RMB: collaborator
• San Giovanni Addolorata Hospital: collaborator
• Campus Bio-Medico University: collaborator
• Ospedale San Paolo Civitavecchia: collaborator
• Ospedale Cristo Re - Roma: collaborator
• S.Eugenio Hospital: collaborator

Study Sites (1)

Fondazione Policlinico Unversitario Agostino Gemelli

Roma, Italy, 00168, Italy

Location

Related Publications (49)

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MeSH Terms

Conditions

Colonic Neoplasms; Diverticulum, Colon

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Diverticulum; Diverticular Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 27, 2017
• Study Start: September 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)