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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.
Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-operative counseling with their caregiver | Active Comparator | Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent. |
|
| caregiver-only counseling. | Placebo Comparator | Parents-only will attend a standard-of-care pre-operative teaching session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Counseling to Patients | Other | In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain rating scores at post-op days 1 and 7 | Minimum value = 0, maximum value = 10. 0 = no pain at all, 10 = worst pain imaginable. A higher score on the rating scale indicates a worse outcome. | 1-7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who have returned to school at 7-days post-op | Yes/no question asking whether the participants has returned to school | 7 days after surgery |
| Rate of medication adherence to ERAS-prescribed medications |
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Inclusion Criteria:
Exclusion Criteria:
This study involves only Gynecologic surgeries.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia S Huguelet, MD | Contact | (720)-777-2238 | patricia.huguelet@cuanschutz.edu | |
| Jaime Laurin, MS | Contact | (720)-777-1375 | jaime.laurin@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Huguelet, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric and Gynecology Clinic at Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| Enhanced recovery after surgery in pediatric and adolescent gynecology: a pilot study. J Pediatr Adolesc Gynecol 2019; 32: 239 | View source |
| Implementation of an enhanced recovery protocol in pediatric colorectal surgery. Journal of pediatric surgery, 53(4), 688-692.Kehlet H. (1997) | View source |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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A randomized trial is proposed that will assess whether patient involvement in pre-operative counseling for ERAS improves post-surgical pain scores. Subject compliance will be assessed to ERAS-prescribed medications, and functionality (return to school). Each patient who is enrolled in the study will be assigned to 1) pre-operative counseling with their caregiver or 2) caregiver-only counseling.
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|
| Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver | Other | In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. |
|
Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.
| 1-7 days after surgery |
| Rate of narcotic medication prescriptions | Documentation of narcotic pain medications used during the post-operative period. Assessed via chart review of medical record. | 1-7 days after surgery |
| The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery | View source |
| The effect of pre-admission education on domiciliary recovery following laparoscopic cholecystectomy | View source |
| Effects of timing and reinforcement of preoperative education on knowledge and recovery of patients having coronary artery bypass graft surgery. Heart \& lung: the journal of critical care, 20(6), 654-660. | View source |
| Preoperative patient preparation in enhanced recovery pathways | View source |
| Subanesthetic ketamine infusions for the treatment of children and adolescents with chronic pain: a longitudinal study. | View source |
| Multimodal approach to control postoperative pathophysiology and rehabilitation. British journal of anaesthesia, 78(5), 606-617. | View source |