NCT04063072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

June 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

August 19, 2019

Last Update Submit

June 1, 2021

Conditions

Uterine Neoplasms

Keywords

HysterectomyUterine Cervical NeoplasmsEndometrial NeoplasmsQuality ImprovementPerioperative CareRecovery of Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Length of stay >12 days

    30 days after admission

  • Recovery after surgery

    24 hours after surgery

  • Complications

    30 days after discharge

  • Transfer to intensive care unit

    30 days after surgery

  • Emergency visits after discharge

    30 days after discharge

  • +4 more secondary outcomes

Study Arms (2)

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.

Procedure: ERAS protocol

Interventions

ERAS protocolPROCEDURE

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.

Also known as: ERAS (Enhanced Recovery After Surgery) protocol
ERAS protocol

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGynecological surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regina Montis Regalis

Mondovì, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30877144BACKGROUND

  • 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.

    PMID: 38404145DERIVED

  • 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.

    PMID: 35622826DERIVED

  • 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.

    PMID: 35289396DERIVED

MeSH Terms

Conditions

Uterine NeoplasmsUterine Cervical NeoplasmsEndometrial Neoplasms

Interventions

Enhanced Recovery After SurgeryClinical Protocols

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, OperativeTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Giovannino Ciccone, MD

    Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

    STUDY CHAIR

Central Study Contacts

Andrea Puppo, MD

CONTACT

0039 0174677andrea.puppo@aslcn1.it

Marco Camanni, MD

CONTACT

0039 011 7095marco.camanni@aslcittaditorino.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologists

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

September 1, 2019

Primary Completion

July 31, 2021

Study Completion

October 31, 2021

Last Updated

June 2, 2021

Record last verified: 2021-06

Locations

IT(1)