Status:
RECRUITING
Same-Day Colectomy: is it Safe for Patients?
Lead Sponsor:
University of Arizona
Conditions:
Colorectal
Colectomy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a prospective cohort study of outcomes of patients undergoing outpatient colorectal surgery at a single institution to study outpatient colectomy as a viable treatment option for a select grou...
Eligibility Criteria
Inclusion
- Ages 18-70
- Undergoing robotic-assisted right colectomy, sigmoidectomy, or low anterior resection.
- Able to perform greater than 4 metabolic equivalents (METS) without shortness of breath
- Must have a designated adult who can care for them at home postoperatively until their in-person clinic visit
- Access to a cell phone or computer and running water.
- Successfully completed pre-operative and post-operative education
- Medical criteria:
- Well controlled hypertension with systolic blood pressure \< 140 controlled by less than two medications which they are compliant with
- Well controlled diabetes on oral agents only with blood glucose level \< 180 on daily checks
- Anti-platelet agents including aspirin, clopidogrel, prasugrel, ticagrelor or ticlopidine will be stopped 7 days preoperatively and restarted on postoperative day 1. See exclusion criteria 7 for specific exclusion criteria regarding antiplatelet agents.
Exclusion
- Medical criteria:
- Neurocognitive deficits not allowing for adequate preoperative education
- Congestive heart failure with EF \< 45%
- Symptomatic aortic stenosis causing heart failure, syncope, dyspnea or angina
- Pulmonary fibrosis or pulmonary hypertension
- COPD or home oxygen use \> 2L
- Chronic kidney disease of any stage.
- Lack of a caregiver at home or functionally bed-bound
- Ultralow pelvic resection
- Need for ostomy creation intraoperatively
- Operative time greater than 5 hours as this likely indicates a complex case and dissection necessitating closer monitoring in the hospital
- Conversion to open procedure intraoperatively
- Patients receiving antiplatelet agents such as clopidogrel, prasugrel, ticagrelor or ticlopidine within one year of coronary or carotid stent implantation, TAVR or LAAO placement.
- Patients on therapeutic anticoagulation medications such as warfarin, Eliquis, Xarelto, Enoxaparin
- Current tobacco use
- Patients who were unable to complete preoperative education, do not feel comfortable with care at home, or do not have an available caregiver for the first 7 postoperative days
- Any surgical history that would preclude safe abdominal entry for robotic surgery
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07176715
Start Date
September 15 2025
End Date
September 1 2030
Last Update
September 16 2025
Active Locations (1)
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1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006