Clinical trial NCT04063072: ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Neoplasms
Keywords: Hysterectomy
Uterine Cervical Neoplasms
Endometrial Neoplasms
Quality Improvement
Perioperative Care
Recovery of Function
Lead sponsor: Ospedale Regina Montis Regalis
Sponsor class: OTHER
Collaborators: name: Martini Hospital, Turin, Italy
name: A.O.U. Città della Salute e della Scienza
name: Ministry of Health, Italy
name: Regione Piemonte
First posted: 2019-08-21
Enrollment: 1800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Length of stay
timeFrame: 12 days after admission
Secondary outcomes:
measure: Length of stay >12 days
timeFrame: 30 days after admission
measure: Recovery after surgery
timeFrame: 24 hours after surgery
measure: Complications
timeFrame: 30 days after discharge
measure: Transfer to intensive care unit
timeFrame: 30 days after surgery
measure: Emergency visits after discharge
timeFrame: 30 days after discharge
measure: Hospital admissions after discharge
timeFrame: 30 days after discharge
measure: Reintervention
timeFrame: 30 days after surgery
measure: Patients' satisfaction
timeFrame: 15 days after discharge
measure: Healthcare costs
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Mondovì
country: Italy
facility: Ospedale Regina Montis Regalis
Study officials:
affiliation: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
name: Giovannino Ciccone, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.