ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy. (ERAS-Gyneco)

June 1, 2021 updated by: Dr. Andrea Puppo, Ospedale Regina Montis Regalis

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy of Benign or Malignant Tumors of the Uterus. A Stepped-wedge Cluster Randomized Clinical Trial.

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 gynaecological 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.

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Mondovì, Italy
        • Recruiting
        • Ospedale Regina Montis Regalis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All the hospital wards within the Piemonte Region performing hysterectomy.
  • All the patients receiving an elective hysterectomy for benign or malignant tumors of the uterus.

Exclusion Criteria:

  • Hospital wards performing less than 20 expected cases per year
  • Emergency hysterectomy
  • Hysterectomy for pelvic floor disorders
  • High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice.
Experimental: ERAS protocol
Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol.
Procedure: ERAS protocol
In gynecological 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, the omission of intestinal preparation, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 12 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 >12 days (98th percentile of the expected distribution).
12 days after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay >12 days
Time Frame: 30 days after admission
Rate of patients with a length of stay >12 days
30 days after admission
Complications
Time Frame: 30 days after discharge
Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index
30 days after discharge
Transfer to intensive care unit
Time Frame: 30 days after surgery
Rate of transfers to intensive care unit after surgery
30 days after surgery
Emergency visits after discharge
Time Frame: 30 days after discharge
Rate of emergency visit in the first month after discharge
30 days after discharge
Hospital admissions after discharge
Time Frame: 30 days after discharge
Rate of new admissions in the first month after discharge
30 days after discharge
Reintervention
Time Frame: 30 days after surgery
Rate of reintervention in the first month after surgery, excluding planned interventions
30 days after surgery
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).
15 days after discharge
Healthcare costs
Time Frame: 30 days after discharge
Mean healthcare costs from pre admission visit to 30 days after discharge
30 days after discharge
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 recovery) 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.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Regina Montis Regalis

Collaborators

Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ministry of Health, Italy
Regione Piemonte
Martini Hospital, Turin, Italy

Investigators

  • Study Chair: Giovannino Ciccone, MD, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERAS-Gyneco-Piemonte

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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