ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of an ERAS Protocol in Gynecological Surgery (ERASGYNBS001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03347409
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Federico Ferrari, Azienda Ospedaliera Spedali Civili di Brescia

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

Condition or disease Intervention/treatment Phase
Surgery Hysterectomy Gynecologic Disease Gynecologic Cancer Anesthesia Other: Changes in preoperative care Other: Changes in intraoperative care Other: Changes in postoperative care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : June 14, 2019
Estimated Study Completion Date : July 15, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Shorter Length Of Hospitalization (LOH) [ Time Frame: Up to 4 weeks after surgery ]
    Total amount of days spent in hospital


Secondary Outcome Measures :
  1. 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)

  2. Presence/Absence of nausea [ Time Frame: At moment 0, 3, 6, 12 and 24 hours after surgery ]
  3. Presence/Absence of vomiting [ Time Frame: At moment 0, 3, 6, 12 and 24 hours after surgery ]
  4. Anesthesiological complications [ Time Frame: Up to 1 weeks after surgery ]
    Rate measurement

  5. Time to bowel movement [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  6. Time to flatus [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  7. Time to hunger [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  8. Time to drink [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  9. Time to eating [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  10. Time to walking [ Time Frame: Up to 4 weeks after surgery ]
    Hours elapsed to event

  11. Postoperative complications [ Time Frame: Up to 9 weeks after surgery ]
    Rate measurement

  12. Compliance to ERAS protocol [ Time Frame: Up to 4 weeks after surgery ]
    Rate measurement

  13. Validated questionnaires [ Time Frame: Administered 24 hours after surgery and up to 4 weeks after surgery ]
    QoR15



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 and <75 years old
  • Patients candidated for elective gynecological surgery for benign pathology (26 patients)
  • Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery (98 patients)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347409


Locations
Italy
Federico Ferrari Recruiting
Brescia, BS, Italy, 25123
Contact: Federico Ferrari, MD    0303995341    f.ferrari.obgyn@gmail.com   
Principal Investigator: Franco Odicino, Prof, MD         
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia

Responsible Party: Federico Ferrari, MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03347409     History of Changes
Other Study ID Numbers: NP 2722
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Federico Ferrari, Azienda Ospedaliera Spedali Civili di Brescia:
ERAS, Fast-track surgery, gynecology

Additional relevant MeSH terms:
Genital Diseases, Female