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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-04169 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated Recovery Protocol | Experimental | Accelerated Recovery after Minimally Invasive Hepatic Surgery (ARAMIS-Hep) Participants randomized to this arm will undergo a recovery pathway that potentially allows for discharge on the day of surgery (post-operative day 0).
You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery |
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| Comparison/Control Arm | Experimental | Standard Post-operative recovery pathway after minimally invasive hepatic surgery. Participants randomized to this arm will undergo our institution's standard recovery pathway for minimally invasive liver surgery.
You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | Survey |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who will be excluded include those with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hop Tran Cao, MD | Contact | (713) 745-4670 | hstran@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Hop Tran Cao, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |