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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05879159
Status
Recruiting
Apply to this trial

Conditions

  • Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Questionnaires — BEHAVIORAL
    Survey

Study Details

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

Key Dates

Start date
Oct 5, 2023
Status verified
Apr 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Accelerated Recovery Protocol
    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
  • Experimental: Comparison/Control Arm
    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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Hop Tran Cao, MD
[email protected]
713-745-4670
Hop Tran Cao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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