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NCT Number: NCT04037787

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Perioperative Care Quality Improvement Recovery of Function Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Santa Croce-Carle Cuneo

Cuneo, 12100, Italy

About this study

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in colorectal surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the hospital wards within the Piemonte Region performing colorectal cancer surgery
  • All the patients receiving an elective surgery for colorectal cancer, with or without protective stoma.

Exclusion criteria

  • Hospital wards performing less than 30 expected cases per year
  • Emergency surgery
  • High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).

Treatment and study plan

ERAS protocol

Procedure

In colorectal cancer surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only (rectal surgery), the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, preference for minimally invasive surgery, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.

Other names: ERAS (Enhanced Recovery After Surgery) protocol

Primary outcomes

  1. Length of stay

    Time frame: 22 days after admission

    Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay >94th percentile of the expected distribution (expected 22 days).

Secondary outcomes

  1. Length of stay >22 days

    Time frame: 30 days after admission

    Rate of patients with a length of stay >22 days

  2. Recovery after surgery

    Time frame: 24 hours after surgery

    Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovey) to 150 (excellent recovery).

    A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.

  3. Complications

    Time frame: 30 days after discharge

    Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index

  4. Transfer to intensive care unit

    Time frame: 30 days after surgery

    Rate of transfers to intensive care unit after surgery

  5. Emergency visits after discharge

    Time frame: 30 days after discharge

    Rate of emergency visit in the first month after discharge

  6. Hospital admissions after discharge

    Time frame: 30 days after discharge

    Rate of new admissions in the first month after discharge

  7. Reintervention

    Time frame: 30 days after surgery

    Rate of reintervention in the first month after surgery, excluding planned interventions

  8. Patients' satisfaction

    Time frame: 15 days after discharge

    Score of patients' satisfaction measured 2 weeks after discharge, assessed with the questionnaire Surgical Satisfaction Questionnaire (SSQ8) supplied by telephone. SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst scenario) to 4 (best scenario) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied).

  9. Healthcare costs

    Time frame: 30 days after discharge

    Mean healthcare costs from pre admission visit to 30 days after discharge

Sponsors and collaborators

Lead sponsor

Ospedale Santa Croce-Carle Cuneo

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • Ministry of Health, Italy
  • Regione Piemonte

Registry information

Official study title

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery. A Stepped-wedge Cluster Randomized Clinical Trial

Acronym: ERAS-Colon

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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