ERAS Preoperative Counseling for Post-Surgical Recovery in Gynecology

Overseen By Patricia S Huguelet, MD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Developmental delay, Emergency surgery, others

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on pre-operative counseling and compliance with ERAS-prescribed medications.

What data supports the effectiveness of the treatment Enhanced Recovery After Surgery (ERAS) Counseling for post-surgical recovery in gynecology?

Research shows that using ERAS protocols in gynecologic surgeries can reduce the use of pain medications like opioids and improve recovery times, helping patients get back to their daily activities more quickly. ^{1 2 3 4 5}

Is the ERAS protocol generally safe for humans?

The ERAS protocol, used in various surgeries including gynecologic and pediatric, is designed to improve recovery and reduce stress from surgery. Studies have shown it to be safe, focusing on enhancing recovery without highlighting any specific safety concerns. ^{1 2 3 5 6}

How is the ERAS preoperative counseling treatment different from other treatments for post-surgical recovery in gynecology?

The ERAS (Enhanced Recovery After Surgery) preoperative counseling treatment is unique because it focuses on a comprehensive approach to reduce stress from surgery and speed up recovery by following a set of evidence-based guidelines. Unlike traditional care, ERAS involves a combination of strategies such as optimizing nutrition, managing pain with fewer opioids, and encouraging early mobilization, which together aim to improve recovery outcomes. ^{1 2 4 7 8}

Research Team

Patricia Huguelet, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for young individuals aged 9-17 who are scheduled for abdominal surgery under the ERAS protocol. They must be accompanied by a caregiver to clinic appointments and not have an emergency or non-elective surgical case. Those with developmental delays (IQ < 70) are excluded.

Inclusion Criteria

I am between 9 and 17 years old.

I am having abdominal surgery and will follow the ERAS recovery plan.

Exclusion Criteria

I require surgery urgently or unexpectedly.

Developmental delay (IQ < 70) determined by documentation in medical record

I go to my clinic appointments without needing someone to take me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Counseling

Participants receive pre-operative counseling with either their caregiver or caregiver-only to improve post-surgical outcomes

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for pain scores, medication adherence, and return to school

1-7 days

Follow-up via chart review and patient report

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
• Enhanced Recovery After Surgery (ERAS) Counseling to Patients

Trial Overview The study is testing if involving patients in pre-operative counseling alongside their caregivers, as opposed to just the caregivers, improves post-surgical pain management, adherence to prescribed medications, and quicker return to school activities.

Participant Groups

Group I: pre-operative counseling with their caregiver Active Control 1 Intervention

Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.

Group II: caregiver-only counseling. Placebo Group 1 Intervention

Parents-only will attend a standard-of-care pre-operative teaching session.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 446 women undergoing gynecologic oncology surgery, achieving over 70% compliance with Enhanced Recovery After Surgery (ERAS) guidelines was linked to significantly lower overall complication rates and shorter hospital stays.

The only independent risk factor for complications identified was intra-operative blood loss greater than 200 mL, highlighting the importance of managing surgical techniques alongside adherence to ERAS protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with enhanced recovery after surgery program in gynecology: are all items of equal importance? Pache, B., Jurt, J., Grass, F., et al.[2019]

The implementation of the Enhanced Recovery After Surgery (ERAS) protocol in 133 women undergoing elective laparotomy led to significantly lower opioid use during and after surgery, compared to a historical cohort of 121 women, indicating a potential for reduced reliance on pain medications.

Patients following the ERAS protocol reported lower pain scores in the post-anesthesia care unit and on the first postoperative day, suggesting improved pain management, while there were no significant changes in hospital stay length or complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in opioid use and postoperative pain scores after elective laparotomy with implementation of enhanced recovery after surgery protocol on a gynecologic oncology service. Schwartz, AR., Lim, S., Broadwater, G., et al.[2020]

The ERAS protocol implemented in gynecological surgery showed no significant difference in length of stay (LOS) between patients undergoing hysterectomy for malignant (2 days) versus benign (2 days) conditions, indicating its effectiveness for both groups.

Patients with malignant and benign conditions had similar rates of complications, reoperations, and readmissions, suggesting that the ERAS protocol is safe and beneficial for enhancing recovery regardless of the nature of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Wijk, L., Franzén, K., Ljungqvist, O., et al.[2018]

The updated ERAS Society guidelines provide a comprehensive consensus on optimal perioperative care specifically for gynecologic and oncology surgeries, based on a thorough review of the latest evidence from meta-analyses, randomized controlled trials, and large cohort studies.

All recommendations within the ERAS protocol are grounded in the best available evidence, ensuring that the guidelines reflect the most effective practices for improving patient outcomes in these surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Nelson, G., Bakkum-Gamez, J., Kalogera, E., et al.[2020]

In a pilot study of 50 patients undergoing elective gynecologic surgeries, the surgical team showed excellent compliance with ERAS guidelines, particularly in preoperative counseling (94%) and intraoperative management (86%).

However, areas needing improvement included preoperative fasting duration, prehabilitation, and early postoperative feeding, indicating that while the team is largely compliant, there are specific practices that could enhance patient recovery further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERAS: An Audit of Existing Practices. Bassetty, KC., Thomas, DS., Sebastian, A., et al.[2023]

The implementation of a pediatric Enhanced Recovery After Surgery (ERAS) protocol for reverse stoma surgery significantly reduced the length of hospital stay from an average of 8.64 days to 6.08 days, indicating improved recovery times.

Patients in the ERAS group experienced faster recovery milestones, such as a decrease in time to oral fluid intake from 4.36 days to 1 day and time to regular diet from 6.14 days to 3.23 days, demonstrating the protocol's efficacy in enhancing postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing enhanced recovery after surgery protocol in pediatric surgery. Modrzyk, A., Pasierbek, MJ., Korlacki, W., et al.[2020]

The Enhanced Recovery After Surgery (ERAS) protocol significantly reduces the length of hospital stay and improves recovery times, such as time to ambulation and bowel function, in 104 patients undergoing minor gynecological surgeries.

Patients following the ERAS protocol required less intravenous fluid and experienced no increase in postoperative complications compared to those receiving conventional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of enhanced recovery protocol with conventional care in patients undergoing minor gynecologic surgery. Yilmaz, G., Akca, A., Kiyak, H., et al.[2022]

The updated ERAS® Society guidelines provide a consensus on optimal perioperative care for gynecologic oncology surgery, addressing specific implementation challenges to improve adherence to Enhanced Recovery After Surgery (ERAS) protocols.

The recommendations are based on the best available evidence from recent studies, including meta-analyses and randomized controlled trials, ensuring that they are grounded in high-quality research to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery (ERAS®) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Nelson, G., Fotopoulou, C., Taylor, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Compliance with enhanced recovery after surgery program in gynecology: are all items of equal importance? [2019]

2. England pubmed.ncbi.nlm.nih.gov

Reduction in opioid use and postoperative pain scores after elective laparotomy with implementation of enhanced recovery after surgery protocol on a gynecologic oncology service. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. [2020]

5. India pubmed.ncbi.nlm.nih.gov

ERAS: An Audit of Existing Practices. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

Introducing enhanced recovery after surgery protocol in pediatric surgery. [2020]

7. Poland pubmed.ncbi.nlm.nih.gov

Comparison of enhanced recovery protocol with conventional care in patients undergoing minor gynecologic surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery (ERAS®) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. [2023]