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

NCT04063072UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Ospedale Regina Montis Regalis

Enrollment

1800

Start Date

2019-09-01

Completion Date

2021-07-31

Study Type

INTERVENTIONAL

Official Title

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.

Interventions

ERAS protocol

Conditions

Uterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

Length of stay

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).

Time frame: 12 days after admission

Secondary Outcomes

Length of stay >12 days

Rate of patients with a length of stay \>12 days

Time frame: 30 days after admission

Recovery 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.

Time frame: 24 hours after surgery

Complications

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

Time frame: 30 days after discharge

Transfer to intensive care unit

Rate of transfers to intensive care unit after surgery

Time frame: 30 days after surgery

Emergency visits after discharge

Rate of emergency visit in the first month after discharge

Time frame: 30 days after discharge

Hospital admissions after discharge

Rate of new admissions in the first month after discharge

Time frame: 30 days after discharge

Reintervention

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

Time frame: 30 days after surgery

Patients' satisfaction

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).

Time frame: 15 days after discharge

Healthcare costs

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

Time frame: 30 days after discharge

Locations

Ospedale Regina Montis Regalis, Mondovì, Italy

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.