Validation of an ERAS Protocol in Gynecological Surgery (ERASGYNBS001)

February 6, 2020 updated by: Federico Ferrari, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial

Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Federico Ferrari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age >18 and <75 years old
  • Patients candidated for elective gynecological surgery for benign pathology
  • Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
  • Signed consent form
  • Karnofsky Performance Status > 70

Exclusion Criteria:

  • ASA score > 3
  • Contraindication to loco-regional anaesthesia
  • Patients with ileus or subocclusive condition prior surgery
  • Coagulation disorders
  • Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
  • Uncontrolled hypertension (>180/95)
  • Alcohol or drug abuser (current or previous)
  • Unability to self-care (PFS < 70)
  • Comorbidity-Polypharmacy Score > 22
  • Psychiatric condition or language barriers
  • Planned Intensive Care Recovery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Perioperative (SP) care
Experimental: ERAS protocol
Other: Changes in preoperative care
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
Other: Changes in intraoperative care
Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
Other: Changes in postoperative care
Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shorter Length Of Hospitalization (LOH)
Time Frame: Up to 4 weeks after surgery
Total amount of days spent in hospital
Up to 4 weeks after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of postoperative pain
Time Frame: At moment 0, 3, 6, 12 and 24 hours after surgery
NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of nausea
Time Frame: At moment 0, 3, 6, 12 and 24 hours after surgery
At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Time Frame: At moment 0, 3, 6, 12 and 24 hours after surgery
At moment 0, 3, 6, 12 and 24 hours after surgery
Anesthesiological complications
Time Frame: Up to 1 weeks after surgery
Rate measurement
Up to 1 weeks after surgery
Time to bowel movement
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Time to flatus
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Time to hunger
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Time to drink
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Time to eating
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Time to walking
Time Frame: Up to 4 weeks after surgery
Hours elapsed to event
Up to 4 weeks after surgery
Postoperative complications
Time Frame: Up to 9 weeks after surgery
Rate measurement
Up to 9 weeks after surgery
Compliance to ERAS protocol
Time Frame: Up to 4 weeks after surgery
Rate measurement
Up to 4 weeks after surgery
Validated questionnaires
Time Frame: Administered 24 hours after surgery and up to 4 weeks after surgery
QoR15
Administered 24 hours after surgery and up to 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP 2722

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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