Clinical trial NCT03347409: Validation of an ERAS Protocol in Gynecological Surgery
Official title: Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Hysterectomy
Gynecologic Disease
Gynecologic Cancer
Anesthesia
Keywords: ERAS, Fast-track surgery, gynecology
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Shorter Length Of Hospitalization (LOH)
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Assessment of postoperative pain
timeFrame: At moment 0, 3, 6, 12 and 24 hours after surgery
measure: Presence/Absence of nausea
timeFrame: At moment 0, 3, 6, 12 and 24 hours after surgery
measure: Presence/Absence of vomiting
timeFrame: At moment 0, 3, 6, 12 and 24 hours after surgery
measure: Anesthesiological complications
timeFrame: Up to 1 weeks after surgery
measure: Time to bowel movement
timeFrame: Up to 4 weeks after surgery
measure: Time to flatus
timeFrame: Up to 4 weeks after surgery
measure: Time to hunger
timeFrame: Up to 4 weeks after surgery
measure: Time to drink
timeFrame: Up to 4 weeks after surgery
measure: Time to eating
timeFrame: Up to 4 weeks after surgery
measure: Time to walking
timeFrame: Up to 4 weeks after surgery
measure: Postoperative complications
timeFrame: Up to 9 weeks after surgery
measure: Compliance to ERAS protocol
timeFrame: Up to 4 weeks after surgery
measure: Validated questionnaires
timeFrame: Administered 24 hours after surgery and up to 4 weeks after surgery
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Federico Ferrari
state: BS
Study officials:
References:
citation: 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.
citation: 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.