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OpenTrials
Completed

NCT Number: NCT03347409

Validation of an ERAS Protocol in Gynecological Surgery

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

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federico Ferrari

Brescia, BS, 25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Changes in preoperative care

Other

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 care

Other

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 care

Other

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 outcomes

  1. Shorter Length Of Hospitalization (LOH)

    Time frame: Up to 4 weeks after surgery

    Total amount of days spent in hospital

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

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

Acronym: ERASGYNBS001

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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