Same-day colectomy safety for selected patients undergoing robotic colorectal surgery.
Same-Day Colectomy: is it Safe for Patients?
NA · University of Arizona · NCT07176715
This project tests whether adults having robotic-assisted right colectomy, sigmoidectomy, or low anterior resection can safely go home the same day after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Arizona (other) |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT07176715 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort at a single academic center following patients selected for outpatient robotic-assisted colorectal operations to record early postoperative outcomes. Eligible patients are adults with good functional capacity and controlled chronic conditions who have a responsible caregiver and access to phone/computer at home. Perioperative requirements include stopping certain antiplatelet drugs before surgery, completion of pre/postoperative education, and same-day discharge with planned clinic follow-up. The study tracks complications, emergency visits, readmissions, and recovery measures to determine whether same-day colectomy is a viable option for a select group of patients.
Who should consider this trial
Good fit: Adults 18–70 undergoing robotic-assisted right colectomy, sigmoidectomy, or low anterior resection with >4 METS functional capacity, controlled hypertension or diabetes as specified, a designated adult caregiver, and access to a phone or computer are ideal candidates.
Not a fit: Patients with poor functional status, uncontrolled medical problems, ongoing antiplatelet therapy that cannot be paused, lack of a home caregiver, or inability to access follow-up resources are unlikely to benefit.
Why it matters
Potential benefit: If successful, selected patients could recover at home sooner with shorter hospital stays, potentially lowering costs and exposure to inpatient risks.
How similar studies have performed: Single-center reports and enhanced recovery programs have shown outpatient colectomy can be feasible and safe in carefully selected patients, but larger randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Phoenix, Arizona
- Banner University Medical Center Phoenix — Phoenix, Arizona, United States (RECRUITING)
Study contacts
- Principal investigator: Eugene Kim, MD — University of Arizona
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal, Colectomy, Colectomy Left/Right/Total Under Laparotomy, Same Day Colectomy, outpatient Colectomy