SurgeryERASGYNBS001NCT03347409
Validation of an ERAS Protocol in Gynecological Surgery
A study testing Changes in preoperative care, Changes in intraoperative care and Changes in postoperative care in people with Surgery and Hysterectomy, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Surgery, Hysterectomy, Gynecologic Disease
- What is being tested?
- Changes in preoperative care, Changes in intraoperative care and Changes in postoperative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2017to 15 Dec 2019
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery, Hysterectomy, Gynecologic Disease, Gynecologic Cancer, Anesthesia
- Being tested
- Changes in preoperative care, Changes in intraoperative care, Changes in postoperative care
- Keywords
- ERAS, Fast-track surgery, gynecology
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in preoperative careOther
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
Changes in intraoperative careOther
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.
Changes in postoperative careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Perioperative (SP) care | No intervention | Not described |
| ERAS protocol | Experimental | Not described Receives: Other: Changes in preoperative care; Other: Changes in intraoperative care; Other: Changes in postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Measured: Up to 4 weeks after surgery
Secondary outcomes (13)
Assessment of postoperative pain
NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
Measured: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of nausea
Measured: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Measured: At moment 0, 3, 6, 12 and 24 hours after surgery
Anesthesiological complications
Rate measurement
Measured: Up to 1 weeks after surgery
Time to bowel movement
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to flatus
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to hunger
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to drink
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to eating
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to walking
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Postoperative complications
Rate measurement
Measured: Up to 9 weeks after surgery
Compliance to ERAS protocol
Rate measurement
Measured: Up to 4 weeks after surgery
Validated questionnaires
QoR15
Measured: Administered 24 hours after surgery and up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start14 Jun 2017
- Primary completion14 Jul 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Ferrari, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347409
- Sponsor's protocol ID
- NP 2722
- Acronym
- ERASGYNBS001
- Status last verified
- Feb 2020
- First submitted
- 27 Oct 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 35289396Ferrari F, Forte S, Sbalzer N, Zizioli V, Mauri M, Maggi C, Sartori E, Odicino F. Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study. Am J Obstet Gynecol. 2020 Oct;223(4):543.e1-543.e14. doi: 10.1016/j.ajog.2020.07.003. Epub 2020 Jul 8.
PubMed 32652064
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03347409
- Acronym / sponsor ID
- ERASGYNBS001 / NP 2722
- Conditions
- Surgery, Hysterectomy, Gynecologic Disease, Gynecologic Cancer, Anesthesia
- Keywords
- ERAS, Fast-track surgery, gynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 14 Jul 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Perioperative (SP) care | No intervention | – |
| ERAS protocol | Experimental | Other: Changes in preoperative care, Other: Changes in intraoperative care, Other: Changes in postoperative care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changes in preoperative careOptimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling | Other | ERAS protocol |
| Changes in intraoperative careBlended 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 | ERAS protocol |
| Changes in postoperative carePostoperative 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. | Other | ERAS protocol |
Primary outcome
Shorter Length Of Hospitalization (LOH)
Time frame: Up to 4 weeks after surgery
Total amount of days spent in hospital
13 secondary outcomes
Assessment of postoperative pain
Time frame: 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
Presence/Absence of vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Anesthesiological complications
Time frame: Up to 1 weeks after surgery
Time to bowel movement
Time frame: Up to 4 weeks after surgery
Time to flatus
Time frame: Up to 4 weeks after surgery
Time to hunger
Time frame: Up to 4 weeks after surgery
Time to drink
Time frame: Up to 4 weeks after surgery
Time to eating
Time frame: Up to 4 weeks after surgery
Time to walking
Time frame: Up to 4 weeks after surgery
Postoperative complications
Time frame: Up to 9 weeks after surgery
Compliance to ERAS protocol
Time frame: Up to 4 weeks after surgery
Validated questionnaires
Time frame: Administered 24 hours after surgery and up to 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 35289396Chau 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.
- Derived from this study: PubMed 32652064Ferrari F, Forte S, Sbalzer N, Zizioli V, Mauri M, Maggi C, Sartori E, Odicino F. Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study. Am J Obstet Gynecol. 2020 Oct;223(4):543.e1-543.e14. doi: 10.1016/j.ajog.2020.07.003. Epub 2020 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes in preoperative care, Changes in intraoperative care and Changes in postoperative care in people with Surgery and Hysterectomy, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 7 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shorter Length Of Hospitalization (LOH) (time frame: Up to 4 weeks after surgery). 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 NCT03347409, which also lists 2 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 7 Feb 2020.