Same-Day Colectomy: is it Safe for Patients?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Same-Day Colectomy
Other interventionstudy, 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
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Same Day ColectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hospital Readmission
The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy
Time frame
30-Days post-procedureSecondary outcomes
1
rate of surgical site infection
Time frame
30-days Post Procedure2
rate of deep surgical infection
Time frame
30-days Post Procedure3
rate of anastomotic leak
Time frame
30-days Post-procedure4
rate of bleeding requiring transfusion
Time frame
30-Days Post-ProcedureSponsors and contacts
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Source ClinicalTrials.gov