Validation of an ERAS Protocol in Gynecological Surgery

NCT ID: NCT03347409

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2019-12-15

Brief Summary

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

Conditions

Surgery; Hysterectomy; Gynecologic Disease; Gynecologic Cancer; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Perioperative (SP) care

Group Type: NO_INTERVENTION

No interventions assigned to this group

ERAS protocol

Group Type: EXPERIMENTAL

Changes in preoperative care

Intervention Type: OTHER

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

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Federico Ferrari

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico Ferrari

Brescia, BS, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 35289396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32652064 (View on PubMed)

Other Identifiers

NP 2722

Identifier Type: -

Identifier Source: org_study_id