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

NCT04063072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2021-06-02

No results posted yet for this study

Summary

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.

Conditions

  • Uterine Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Martini Hospital, Turin, Italy

    collaborator OTHER

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Regione Piemonte

    collaborator OTHER

  • Ospedale Regina Montis Regalis

    lead OTHER

Principal Investigators

  • Giovannino Ciccone, MD · Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-07-31
Completion
2021-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063072 on ClinicalTrials.gov