BridgeMD
New treatment option for Colorectal
Official title Same-Day Colectomy: is it Safe for Patients?
ClinicalTrials.gov ID: NCT07176715
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.