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Same-Day Colectomy: is it Safe for Patients?

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University of Arizona

Status

Enrolling

Conditions

Colectomy Left/Right/Total Under Laparotomy
Colorectal
Colectomy

Treatments

Other: Same-Day Colectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07176715
STUDY00003441

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Same Day Colectomy
Experimental group
Treatment:
Other: Same-Day Colectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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