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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Uterine Neoplasms

Intervention / Treatment
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* Procedure: ERAS protocol


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A stepped-wedge cluster randomized clinical trial. Each center starts as control group (usual care) and switch to experimental group (ERAS protocol implementation) according to a randomized order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice. | |
| Experimental: ERAS protocol<br>Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol. | Procedure: ERAS protocol<br>* 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.<br>* Other names: ERAS (Enhanced Recovery After Surgery) protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 days after admission | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, Uterine Cervical Neoplasms, Endometrial Neoplasms, Quality Improvement, Perioperative Care, Recovery of Function