Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Liver

Treatments: Behavioral: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05879159

2022-0917

NCI-2023-04169 (Other Identifier)

Details and patient eligibility

About

To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Accelerated Recovery Protocol

Experimental group

Description:

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 receive a clear liquid diet, be encouraged to ambulate independently, and opioid use will be minimized in the recovery unit. * You will be assessed in the post-operative recovery unit. If you meet discharge criteria, you will be discharged the afternoon/evening of surgery. If you do not, you will be admitted for overnight observation. * You will have a telehealth video visit on post-operative days 1 and 2 * You will have in-person clinic visit within 14 days of discharge. You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery

Treatment:

Behavioral: Questionnaires

Comparison/Control Arm

Experimental group

Description:

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 be transferred to the Transitional PACU for overnight observation. * Your diet will be advanced to gastrointestinal "first food" diet on Post-operative Day 1, with opioid weaning and frequent ambulation. * You will be discharged once criteria are met. * You will have an in-person clinic visit within 14 days of discharge. You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery.

Treatment:

Behavioral: Questionnaires