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Purpose

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 group of patients requiring colon and rectal surgery.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

  1. 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
The purpose of this study is to show that outpatient colectomy is safe and feasible for patients that were rigorously screened preoperatively. - The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy. - Secondary outcomes include rate of surgical site infection, deep surgical infection, anastomotic leak, bleeding requiring transfusion, postoperative ileus, reoperation, reintervention, acute kidney injury or renal failure, reintubation or need for prolonged ventilation, mortality.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Same Day Colectomy
  • Other: Same-Day Colectomy
    study, they will undergo extensive education during their preoperative visit. Perioperative education includes management of perioperative medications, bowel prep and perioperative antibiotics. Perioperative education will include that of the patient and their designated caregiver. Perioperative nursing staff will go over postoperative discharge instructions again. A custom discharge instruction sheet will be made and given to all patients upon discharge. On days 1 and 3 postoperatively, patients will receive a phone call or virtual visit from a member of the research team. Questions will be asked of patients based on a script made. Patients will then be seen in the clinic between postoperative day 5-7. Patients' medical record will be followed for six months postoperatively to track emergency department visits, readmissions, and postoperative complications. Postoperative complications will include surgical site infection, deep surgical infection, bleeding requiring transfusion, ana
    Other names:
    • Outpatient Colectomy

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
Contact:
Crystal Gonzalez, MSW
602-255-7553
crgonzalez4@arizona.edu

More Details

Status
Recruiting
Sponsor
University of Arizona

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.