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Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Perioperative (SP) care | No Intervention | ||
| ERAS protocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shorter Length Of Hospitalization (LOH) | Total amount of days spent in hospital | Up to 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of postoperative pain | 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 | At moment 0, 3, 6, 12 and 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico Ferrari | Brescia | BS | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35289396 | Derived | 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. | |
| 32652064 | Derived | Ferrari 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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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D011300 | Preoperative Care |
| D007430 | Intraoperative Care |
| D011182 | Postoperative Care |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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. |
|
| Presence/Absence of vomiting | At moment 0, 3, 6, 12 and 24 hours after surgery |
| Anesthesiological complications | Rate measurement | Up to 1 weeks after surgery |
| Time to bowel movement | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to flatus | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to hunger | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to drink | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to eating | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to walking | Hours elapsed to event | Up to 4 weeks after surgery |
| Postoperative complications | Rate measurement | Up to 9 weeks after surgery |
| Compliance to ERAS protocol | Rate measurement | Up to 4 weeks after surgery |
| Validated questionnaires | QoR15 | Administered 24 hours after surgery and up to 4 weeks after surgery |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |