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| Name | Class |
|---|---|
| Martini Hospital, Turin, Italy | OTHER |
| A.O.U. Città della Salute e della Scienza | OTHER |
| Ministry of Health, Italy | OTHER_GOV |
| Regione Piemonte |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice. | |
| ERAS protocol | Experimental | Perioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Procedure | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Gynecological surgery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Puppo, MD | Contact | 0039 0174677 | 470 | andrea.puppo@aslcn1.it |
| Marco Camanni, MD | Contact | 0039 011 7095 | 2531 | marco.camanni@aslcittaditorino.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovannino Ciccone, MD | Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regina Montis Regalis | Recruiting | Mondovì | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30877144 | Background | Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15. | |
| 38404145 |
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| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
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| OTHER |
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.
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|
| 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 |
| Derived |
| Piovano E, Puppo A, Camanni M, Castiglione A, Delpiano EM, Giacometti L, Rolfo M, Rizzo A, Zola P, Ciccone G, Pagano E; ERAS-Gyneco Piemonte Group. Implementing Enhanced Recovery After Surgery for hysterectomy in a hospital network with audit and feedback: A stepped-wedge cluster randomised trial. BJOG. 2024 Aug;131(9):1207-1217. doi: 10.1111/1471-0528.17797. Epub 2024 Feb 25. |
| 35622826 | Derived | Piovano E, Pagano E, Del Piano E, Rinaldi F, Palazzo V, Coata P, Bongiovanni D, Rolfo M, Ceretto Giannone L, Veliaj D, Camanni M, Puppo A, Ciccone G; ERAS-Gyneco Piemonte group. Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy in the Piedmont Region with an audit&feedback approach: Study protocol for a stepped wedge cluster randomized controlled trial. A study of the EASY-NET project. PLoS One. 2022 May 27;17(5):e0268655. doi: 10.1371/journal.pone.0268655. eCollection 2022. |
| 35289396 | Derived | Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5. |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |