Validation of an ERAS Protocol in Gynecological Surgery

Surgery Clinical Trial

— ERASGYNBS001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347409
• Other study ID #: NP 2722
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 15, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Genital Diseases, Female
• Gynecologic Cancer
• Gynecologic Disease
• Hysterectomy
• Surgery

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Federico Ferrari	Brescia	BS

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shorter Length Of Hospitalization (LOH)	Total amount of days spent in hospital	Up to 4 weeks after surgery
Secondary	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
Secondary	Presence/Absence of nausea		At moment 0, 3, 6, 12 and 24 hours after surgery
Secondary	Presence/Absence of vomiting		At moment 0, 3, 6, 12 and 24 hours after surgery
Secondary	Anesthesiological complications	Rate measurement	Up to 1 weeks after surgery
Secondary	Time to bowel movement	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to flatus	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to hunger	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to drink	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to eating	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Time to walking	Hours elapsed to event	Up to 4 weeks after surgery
Secondary	Postoperative complications	Rate measurement	Up to 9 weeks after surgery
Secondary	Compliance to ERAS protocol	Rate measurement	Up to 4 weeks after surgery
Secondary	Validated questionnaires	QoR15	Administered 24 hours after surgery and up to 4 weeks after surgery