Pelvic CancerPORTSNCT04344899
Pediatric Oncology Recovery Trial After Surgery
An observational study of Pelvic Cancer, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pelvic Cancer
- What is being tested?
- Observational
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2019to 11 Mar 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing urological surgery
Who may be able to join
- Patients undergoing operations at a pediatric hospital setting aged 1 month or older
- Parents of patients undergoing operations at pediatric hospital settings aged 1 month or older
- Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures
- Providers of patients undergoing surgery in pediatric settings
Who cannot join
- Less than 1 month in age
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. A pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. After completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying ERAS protocol developed for this project.
Read the detailed description
Two arms:
Historical patients ERAS patients
Number of patients: 288
Primary outcome
- Number of 90-day complications by Clavien-Dindo classification
Secondary outcome(s):
- Adherence to ERAS protocol items with # of items achieved (out of 20)
- Length of stay
- Re-admissions within 90 days
- Re-operations within 90 days
- Number of visits to the emergency room within 90 day period
- Minimum, mean, maximum daily pain score during first 7 days after surgery
- Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
- recurrence free survival (months)
- overall survival (months)
- Conditions
- Pelvic Cancer
- Being tested
- Observational
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Also called ERAS Protocol
Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.
| Study group | Role | What they receive |
|---|---|---|
| Historical | Retrospective Review Receives: Other: Observational | |
| ERAS Patients | Prospective Review Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 90-day complications by Clavien-Dindo classification
Measured: 90 Days
Secondary outcomes (9)
Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)
Measured: 90 Days
Length of stay
Measured: 90 Days
Number of Re-admissions within 90 days
Measured: 90 Days
Number of Re-operations within 90 days
Measured: 90 Days
Number of visits to the emergency room within 90 day period
Measured: 90 Days
VAS daily pain score during first 7 days after surgery
Measured: 90 Days
Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
Measured: 90 Days
Recurrence free survival (months)
Measured: 90 Days
Overall survival (months)
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start23 Jul 2019
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Rove, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344899
- Sponsor's protocol ID
- 19-0964.cc
- Other IDs
- NCI-2021-10775
- Acronym
- PORTS
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansfield SA, Kotagal M, Hartman S, Murphy AJ, Davidoff AM, Anghelescu DL, Mecoli M, Cost N, Hogan B, Rove KO. Development of an enhanced recovery after surgery program for pediatric solid tumors. Front Surg. 2024 May 22;11:1393857. doi: 10.3389/fsurg.2024.1393857. eCollection 2024.
PubMed 38840973
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Oncology Recovery Trial After Surgery
- ClinicalTrials.gov ID
- NCT04344899
- Acronym / sponsor ID
- PORTS / 19-0964.cc
- Conditions
- Pelvic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. A pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. After completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying ERAS protocol developed for this project.
Detailed description
Two arms:
Historical patients ERAS patients
Number of patients: 288
Primary outcome
- Number of 90-day complications by Clavien-Dindo classification
Secondary outcome(s):
- Adherence to ERAS protocol items with # of items achieved (out of 20)
- Length of stay
- Re-admissions within 90 days
- Re-operations within 90 days
- Number of visits to the emergency room within 90 day period
- Minimum, mean, maximum daily pain score during first 7 days after surgery
- Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
- recurrence free survival (months)
- overall survival (months)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical | – | Other: ObservationalRetrospective Review |
| ERAS Patients | – | Other: ObservationalProspective Review |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing urological surgery
Key inclusion criteria (4 listed)
- Patients undergoing operations at a pediatric hospital setting aged 1 month or older
- Parents of patients undergoing operations at pediatric hospital settings aged 1 month or older
- Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures
- Providers of patients undergoing surgery in pediatric settings
Key exclusion criteria (1 listed)
- Less than 1 month in age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAlso: ERAS ProtocolEnhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. | Other | ERAS Patients, Historical |
Primary outcome
Number of 90-day complications by Clavien-Dindo classification
Time frame: 90 Days
9 secondary outcomes
Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)
Time frame: 90 Days
Length of stay
Time frame: 90 Days
Number of Re-admissions within 90 days
Time frame: 90 Days
Number of Re-operations within 90 days
Time frame: 90 Days
Number of visits to the emergency room within 90 day period
Time frame: 90 Days
VAS daily pain score during first 7 days after surgery
Time frame: 90 Days
Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery
Time frame: 90 Days
Recurrence free survival (months)
Time frame: 90 Days
Overall survival (months)
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 38840973Mansfield SA, Kotagal M, Hartman S, Murphy AJ, Davidoff AM, Anghelescu DL, Mecoli M, Cost N, Hogan B, Rove KO. Development of an enhanced recovery after surgery program for pediatric solid tumors. Front Surg. 2024 May 22;11:1393857. doi: 10.3389/fsurg.2024.1393857. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Rove, MD principal investigator
Children's Hospital Colorado
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Cancer, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 90-day complications by Clavien-Dindo classification (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.