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Uterine NeoplasmsERAS-GynecoNCT04063072

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

A study testing ERAS protocol in people with Uterine Neoplasms, run by Ospedale Regina Montis Regalis at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Neoplasms
What is being tested?
ERAS protocol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
1 siteItaly
Study dates
1 Sep 2019to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Andrea Puppo, MD contact

0039 0174677 ext. 470

andrea.puppo@aslcn1.it

Marco Camanni, MD contact

0039 011 7095 ext. 2531

marco.camanni@aslcittaditorino.it

Italy1 site, 1 recruiting

  • Ospedale Regina Montis Regalis

    Mondovì

    Recruiting

Other trials in Italy

About this study

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.

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.

Read the 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.

Being tested
ERAS protocol
Keywords
Hysterectomy, Uterine Cervical Neoplasms, Endometrial Neoplasms, Quality Improvement, Perioperative Care, Recovery of Function
Medical subject headings
Uterine Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS protocolProcedure or surgery

    Also called ERAS (Enhanced Recovery After Surgery) protocol

    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.

Study groups in NCT04063072
Study groupRoleWhat they receive
Usual careNo interventionPerioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to current hospital clinical practice.
ERAS protocolExperimentalPerioperative care for hysterectomy of benign or malignant tumors of the uterus is managed according to ERAS protocol.
Receives: Procedure: ERAS protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 days after admission

Secondary outcomes (9)

  1. Length of stay >12 days

    Rate of patients with a length of stay >12 days

    Measured: 30 days after admission

  2. 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.

    Measured: 24 hours after surgery

  3. Complications

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

    Measured: 30 days after discharge

  4. Transfer to intensive care unit

    Rate of transfers to intensive care unit after surgery

    Measured: 30 days after surgery

  5. Emergency visits after discharge

    Rate of emergency visit in the first month after discharge

    Measured: 30 days after discharge

  6. Hospital admissions after discharge

    Rate of new admissions in the first month after discharge

    Measured: 30 days after discharge

  7. Reintervention

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

    Measured: 30 days after surgery

  8. 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).

    Measured: 15 days after discharge

  9. Healthcare costs

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

    Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start1 Sep 2019
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion31 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04063072
Sponsor's protocol ID
ERAS-Gyneco-Piemonte
Acronym
ERAS-Gyneco
Status last verified
Jun 2021
First submitted
19 Aug 2019
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30877144

  • 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.

    PubMed 38404145

  • 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.

    PubMed 35622826

  • 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.

    PubMed 35289396

Questions about this trial

What is this clinical trial studying?

A study testing ERAS protocol in people with Uterine Neoplasms, run by Ospedale Regina Montis Regalis at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Puppo, MD (0039 0174677 ext. 470, andrea.puppo@aslcn1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay (time frame: 12 days after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04063072, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.

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