Federico Ferrari
Brescia, BS, 25123, Italy
NCT Number: NCT03347409
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
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Notify Me18 year–75 year
Female
Interventional
Not applicable
Brescia, BS, 25123, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
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.
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.
Time frame: Up to 4 weeks after surgery
Total amount of days spent in hospital
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)
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Time frame: Up to 1 weeks after surgery
Rate measurement
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Hours elapsed to event
Time frame: Up to 9 weeks after surgery
Rate measurement
Time frame: Up to 4 weeks after surgery
Rate measurement
Time frame: Administered 24 hours after surgery and up to 4 weeks after surgery
QoR15
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Other
Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
Acronym: ERASGYNBS001
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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