Same-Day Colectomy for Colon Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Neurocognitive deficits, Heart failure, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a same-day colectomy, a surgery to remove part of the colon, can effectively treat colon cancer. Researchers aim to determine if patients can safely return home the same day after the procedure. The trial is ideal for individuals who can perform daily activities without breathlessness and have stable blood pressure and diabetes managed with oral medication. Participants must have a caregiver at home after surgery and access to a phone or computer. As an unphased trial, this study provides a unique opportunity to contribute to advancements in innovative surgical care.

Do I have to stop taking my current medications for the trial?

You will need to stop taking anti-platelet medications like aspirin and clopidogrel 7 days before the surgery and can restart them the day after surgery. The protocol does not specify other medications, so it's best to discuss with the trial team.

What prior data suggests that same-day colectomy is safe for patients undergoing colon and rectal surgery?

Studies have shown that same-day colectomy, where patients go home the same day after surgery, can be safe for some individuals. In one study, nearly half of the 86 patients who had a planned colectomy left the hospital the same day without any problems. Another report found that almost 60 patients successfully followed these guidelines, achieving positive results.

Additionally, the short-term risks of this procedure, such as serious health issues or needing to return to the hospital, were generally low. Patients did not face major issues within 30 days after surgery. This suggests that same-day colectomy might be a well-tolerated option for some patients needing colon surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Same-Day Colectomy for colon cancer because it could significantly reduce recovery time and hospital stays compared to traditional colectomy procedures. Standard treatments often require several days of hospitalization, but this approach aims to let patients go home the same day, potentially improving patient comfort and reducing healthcare costs. Additionally, a quicker recovery may lead to faster return to daily activities, which is a significant benefit for patients' quality of life.

What evidence suggests that same-day colectomy is effective for colon cancer?

Research has shown that some patients can safely go home the same day after a minimally invasive colectomy, a surgery to remove part of the colon. Studies report success rates ranging from 22% to 98%, indicating effectiveness for some individuals. One study found that about 22% to 35% of patients were able to leave the hospital within 24 hours. The trial will evaluate the effectiveness and safety of the Same-Day Colectomy approach. This method is safe for certain patients and might help reduce healthcare costs. Although it does not significantly change short-term quality of life compared to traditional methods, it still offers promising results for those who qualify. ^{1 3 4 6 7}

Who Is on the Research Team?

Eugene Kim, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who need certain types of colon surgery and are in good physical condition with well-controlled blood pressure or diabetes. They must have a caregiver, access to technology, and be able to complete educational sessions before and after surgery. Smokers, those with severe heart, lung or kidney conditions, or complex surgical histories are excluded.

Inclusion Criteria

Able to perform greater than 4 metabolic equivalents (METS) without shortness of breath

Access to a cell phone or computer and running water

I am between 18 and 70 years old.

Exclusion Criteria

Neurocognitive deficits not allowing for adequate preoperative education

Current tobacco use

My heart's pumping ability is reduced (EF < 45%).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo outpatient colorectal surgery (same-day colectomy)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person), additional follow-up as needed

What Are the Treatments Tested in This Trial?

Interventions

• Same-Day Colectomy

Trial Overview The study is testing the safety of same-day colectomy (colon removal) as an outpatient procedure at one medical center. It focuses on patients undergoing robotic-assisted right colectomy, sigmoidectomy, or low anterior resection without requiring hospitalization post-surgery.

How Is the Trial Designed?

Group I: Same Day Colectomy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11411116/

Same-Day Discharge After a Minimally Invasive Colectomy A systematic review evaluated the success rate of SDD in four studies, with a notable success rate of 47% (range 22%-98%) [19]. Notably, the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9491699/

Same day discharge following elective, minimally invasive ... Results from single-center series suggest that discharge within 24 h occurred in 22–35% of patients undergoing laparoscopic colorectal resection ...

3. americanjournalofsurgery.com americanjournalofsurgery.com/article/S0002-9610(24)00573-7/abstract

National trends and costs of same day discharge in ... Same day discharge after minimally invasive colectomy is safe for some patients. Studies to capture its impact on cost are lacking.

4. reports.mountsinai.org reports.mountsinai.org/article/gi2026-same-day-surgery-discharge

Same-Day Discharge of Colorectal Surgery Patients Is ... Since December 2023, nearly 60 patients have been enrolled under its guidelines, with highly encouraging results that generally support the feasibility and ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/194570

Short-term Quality-of-Life Outcomes Following ... Only minimal short-term QOL benefits were found with LAC for colon cancer compared with standard open colectomy.

6. trial.medpath.com trial.medpath.com/clinical-trial/d663c46e325e3daa/nct07176715-same-day-colectomy-safety

Same-Day Colectomy: is it Safe for Patients? | MedPath This is a prospective cohort study of outcomes of patients undergoing outpatient colorectal surgery at a single institution to study ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1007/s00268-023-07041-1

Safety and Feasibility of ≤24‐h Short‐Stay Right ... Primary outcomes were 30-day overall and serious morbidity. Secondary outcomes were 30-day mortality, readmission, and anastomotic leak. The ...