Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery

NCT07720089 — Not applicable, Not yet recruiting, 66 participants, University of Alabama at Birmingham

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Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study

RegistryNCT07720089
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment66 (Estimated)
SponsorUniversity of Alabama at Birmingham (Other)
ConditionsCancer, Abdominal Cancer Surgery, Surgery, Recovery Outcomes, Functional Outcomes
InterventionsAlgorithmic Guideline for Functional Recovery following Cancer Surgery (Behavioral)
Datesstart 2027-09-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-07-22, last updated 2026-08-26
Locations2 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cancer All trials for Abdominal Cancer Surgery All trials of Algorithmic Guideline for Functional Recovery following Cancer Surgery

-Summary

The objective of this study is to develop and evaluate the implementation of novel timeline-specific National Comprehensive Cancer Network (NCCN)-style clinical guidelines designed to improve functional outcomes after high-risk abdominal surgery for cancer.

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+Detailed description

This is a prospective, feasibility, and effectiveness trial to be conducted at The University of Alabama at Birmingham. We plan to develop algorithmic guidelines focused on proactive support of surgical recovery and will then recruit surgeons who care for adults undergoing high-risk abdominal surgery for cancer to study the preliminary effectiveness of implementing the algorithmic guidelines into postoperative care workflows at 4 pre-determined timepoints. A modified Delphi process will be used to ensure an expert consensus on the algorithmic guideline content is achieved through a rigorous and consensus-driven process. Two rounds of structured online voting will be conducted to rate and refine each algorithmic guideline component.

Key feasibility outcomes include recruitment and retention rates, surgeon adherence, data completeness, and integration into routine workflows. Preliminary effectiveness will be measured using patient-reported outcomes, timeliness of referral to supportive providers and resources, use of supportive services, rates of surgical regret, and measures of functional recovery.

+Arms and interventions

ArmTypeInterventionsDescription
SurgeonsExperimentalBehavioral: Algorithmic Guideline for Functional Recovery following Cancer SurgerySurgeons will be given a postoperative decision support guideline for assessment of functional recovery
  • Algorithmic Guideline for Functional Recovery following Cancer Surgery (Behavioral): This is a pilot feasibility study to test the clinical use of a novel algorithmic guideline to support patient functional recovery following cancer surgery. To date, no algorithmic guideline exists to support functional recovery as a primary postoperative outcome.

+Outcome measures

Primary outcomes

  • Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery [6 months]: The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery. This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Surgeons who perform abdominal surgery for cancer at the study institution

Exclusion Criteria:

* Surgeons who do not perform abdominal surgery for cancer
* Surgeons who are external to the study institution

+Locations (2)

FacilityCityCountryStatus
University of Alabama at BirminghamBirmingham, AlabamaUnited States
University of Alabama at BirminghamBirmingham, AlabamaUnited States

+Investigators