Same-Day Colectomy: is it Safe for Patients?

Not Applicable

Recruiting

• Conditions: Colorectal; Colectomy; Colectomy Left/Right/Total Under Laparotomy

• Registration Number: NCT07176715
• Lead Sponsor: University of Arizona

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 group of patients requiring colon and rectal surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study Start: 2025-09-15
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2029-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hospital Readmission	30-Days post-procedure	The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy

Secondary Outcome Measures

Name	Time	Method
rate of surgical site infection	30-days Post Procedure
rate of deep surgical infection	30-days Post Procedure
rate of anastomotic leak	30-days Post-procedure
rate of bleeding requiring transfusion	30-Days Post-Procedure
rate of postoperative ileus	30-Days Post-Procedure
rate of reoperation	30-Days Post-Procedure
reintervention	30-Days Post-Procedure
rate of acute kidney injury or renal failure	30-Days Post-Procedure
rate of reintubation or need for prolonged ventilation	30-Days Post-Procedure
Rate of mortality	30-Days Post Procedure

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States