Validation of an ERAS Protocol in Gynecological Surgery

NCT03347409 | Completed

• 1 other identifier: NP 2722
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgery; Hysterectomy; Gynecologic Disease; Gynecologic Cancer; Anesthesia

Keywords

ERAS, Fast-track surgery, gynecology

Outcome Measures

Primary Outcomes (1)

• Shorter Length Of Hospitalization (LOH)

  Total amount of days spent in hospital

  Up to 4 weeks after surgery

Secondary Outcomes (13)

• Assessment of postoperative 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

• Presence/Absence of vomiting

  At moment 0, 3, 6, 12 and 24 hours after surgery

• Anesthesiological complications

  Up to 1 weeks after surgery

• Time to bowel movement

  Up to 4 weeks after surgery

Study Arms (2)

Standard Perioperative (SP) care

NO INTERVENTION

ERAS protocol

EXPERIMENTAL

Other: Changes in preoperative care; Other: Changes in intraoperative care; Other: Changes in postoperative care

Interventions

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

ERAS protocol

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.

ERAS protocol

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.

ERAS protocol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Federico Ferrari

Brescia, BS, 25123, Italy

Location

Related Publications (2)

• 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.

  PMID: 35289396 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.

  PMID: 32652064 DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Preoperative Care; Intraoperative Care; Postoperative Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 20, 2017
• Study Start: June 14, 2017
• Primary Completion: July 14, 2019
• Study Completion: December 15, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

IT (1)