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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Hop Tran Cao, MD
hstran@mdanderson.org
(713) 745-4670
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 36
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Intuitive Surgical Inc

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.