Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.
Detailed description
Primary Objectives:
Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.
Secondary Objectives:
In addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.
Interventions
- Behavioral Questionnaires
Survey
Primary outcome measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Time frame: through study completion; an average of 1 year.]
Eligibility criteria
Inclusion criteria
- Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)
- No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)
- No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection
- Ability to stay within 50 miles of medical center for immediate postop period
- Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients <18 years of age, children are excluded from this study
- Ability to understand and the willingness to sign a written informed consent document
- Non-English-speaking patients are eligible for participation
Exclusion criteria
Patients who will be excluded include those with:
- Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy
- Tumors not amenable to MIS or Robotic-assisted surgical resection
- Evidence of Cirrhosis on imaging, clinically, or lab testing
- Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period
- Age below 18 years
- Inability to consent for trial/protocol
- Patients who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05879159 · 2022-0917 · NCI-2023-04169