An interventional study of Enhanced Recovery After Surgery (ERAS) Counseling to Patients and Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver in Enhanced Recovery After Surgery and Gynecologic Disease, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to female participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other
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Among 31 studies in Genital Diseases, Female with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Genital Diseases, Female · United States.
Among the 31 studies in Genital Diseases, Female with a site in United States, this one is the 8th largest by planned enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2022, is one of 14 with no phase, and was the 20th registered.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
Browse Genital Diseases, Female studies →5 of the 31 studies in Genital Diseases, Female with a site in United States are open now. Recruiting first, the newest first:
University of Southern California · Sites in United States
Ages 18+ · Women only
Nanopath, Inc · Sites in United States
Ages 18+ · Women only
Stanford University · Sites in United States
Ages 18+
Pfizer · Sites in United States, Puerto Rico
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 9 Years to 17 Years · female · no healthy volunteers.
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31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 3 · Phase 4 3
First in 2003; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Median enrollment 50 across the 24 interventional studies, 48 across the 7 observational. Of the 19 that completed or were terminated, 8 (42%) have results posted.
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11 of 31 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 2 studies filed under Genital Diseases, Female — fewer than ten, so there is no comparison to draw.
4 of the studies in Genital Diseases, Female with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07607470Nanopath, IncLarge Algorithm Setting and Validation Study | 2026-12 |
| NCT07044505Stanford UniversityMolecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery | 2026-12 |
| NCT06611501Boston Children's HospitalGlycemic Regulation as Endometriosis Adjunct Treatment | 2027-01 |
| NCT07279571University of Southern CaliforniaGYN-AIDE: Gynecologic Oncology Navigation Through AI-Driven Education | 2027-06-09 |
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Among the 31 studies in Genital Diseases, Female with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.
Other: Enhanced Recovery After Surgery (ERAS) Counseling to Patients
Parents-only will attend a standard-of-care pre-operative teaching session.
Other: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
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.
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.
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.
Time frame: 1-7 days after surgery
Number of participants who have returned to school at 7-days post-op
Yes/no question asking whether the participants has returned to school
Time frame: 7 days after surgery
Rate of medication adherence to ERAS-prescribed medications
Participants reported adherence to ERAS medications during the post-operative period measured by asking patients which medications they are taking.
Time frame: 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.
Time frame: 1-7 days after surgery
Started Sep 2022 (actual). Primary completion is estimated for Jan 2028, 64 months after the start.
Of 55 non-industry interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 64 months is above that.
Counting every sponsor, half of 65 studies reached it within 14 months; a quarter within 8 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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University of Colorado, Denver →