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ColorectalNCT07176715

Same-Day Colectomy: is it Safe for Patients?

A study testing Same-Day Colectomy in people with Colorectal and Colectomy, run by University of Arizona at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Same-Day Colectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
25 Sep 2025to 1 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Crystal Gonzalez, MSW, 602-255-7553, crgonzalez4@arizona.edu

    Elena Young, 6022557553, elenay@arizona.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Same-Day Colectomy
Keywords
Same Day Colectomy, outpatient Colectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Same-Day ColectomyOther

    Also called Outpatient Colectomy

    study, 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

Study groups in NCT07176715
Study groupRoleWhat they receive
Same Day ColectomyExperimentalNot described
Receives: Other: Same-Day Colectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Readmission

    The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy

    Measured: 30-Days post-procedure

Secondary outcomes (10)

  1. rate of surgical site infection

    Measured: 30-days Post Procedure

  2. rate of deep surgical infection

    Measured: 30-days Post Procedure

  3. rate of anastomotic leak

    Measured: 30-days Post-procedure

  4. rate of bleeding requiring transfusion

    Measured: 30-Days Post-Procedure

  5. rate of postoperative ileus

    Measured: 30-Days Post-Procedure

  6. rate of reoperation

    Measured: 30-Days Post-Procedure

  7. reintervention

    Measured: 30-Days Post-Procedure

  8. rate of acute kidney injury or renal failure

    Measured: 30-Days Post-Procedure

  9. rate of reintubation or need for prolonged ventilation

    Measured: 30-Days Post-Procedure

  10. Rate of mortality

    Measured: 30-Days Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start25 Sep 2025
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The purpose of this study is to show that outpatient colectomy is safe and feasible for patients that were rigorously screened preoperatively. * The primary outcome of this study is the 30-day rate of readmission to the hospital following same day colectomy. * Secondary outcomes include rate of surgical site infection, deep surgical infection, anastomotic leak, bleeding requiring transfusion, postoperative ileus, reoperation, reintervention, acute kidney injury or renal failure, reintubation or need for prolonged ventilation, mortality.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176715
Sponsor's protocol ID
STUDY00003441
Status last verified
Sep 2025
First submitted
9 Sep 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bourgouin S, Monchal T, Schlienger G, Franck L, Lacroix G, Balandraud P. Eligibility criteria for ambulatory colectomy. J Visc Surg. 2022 Feb;159(1):21-30. doi: 10.1016/j.jviscsurg.2020.11.012. Epub 2020 Dec 19.

    PubMed 33349570

  • Studniarek A, Borsuk DJ, Kochar K, Park JJ, Marecik SJ. Feasibility assessment of outpatient colorectal resections at a tertiary referral center. Int J Colorectal Dis. 2021 Mar;36(3):501-508. doi: 10.1007/s00384-020-03782-w. Epub 2020 Oct 22.

    PubMed 33094353

  • Campbell S, Fichera A, Thomas S, Papaconstantinou H, Essani R. Outpatient colectomy-a dream or reality? Proc (Bayl Univ Med Cent). 2021 Sep 16;35(1):24-27. doi: 10.1080/08998280.2021.1973327. eCollection 2022.

    PubMed 34970026

  • Lee L, Eustache J, Tran-McCaslin M, Basam M, Baldini G, Rudikoff AG, Liberman S, Feldman LS, McLemore EC. North American multicentre evaluation of a same-day discharge protocol for minimally invasive colorectal surgery using mHealth or telephone remote post-discharge monitoring. Surg Endosc. 2022 Dec;36(12):9335-9344. doi: 10.1007/s00464-022-09208-8. Epub 2022 Apr 13.

    PubMed 35419638

  • Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.

    PubMed 25661787

  • Curfman KR, Poola AS, Blair GE, Kosnik CL, Pille SA, Thilo EL, Hawkins ME, Rashidi L. Ambulatory colectomy: A pilot protocol for same day discharge in minimally invasive colorectal surgery. Am J Surg. 2022 Aug;224(2):757-760. doi: 10.1016/j.amjsurg.2022.04.039. Epub 2022 May 11.

    PubMed 35570059

  • Gignoux B, Gosgnach M, Lanz T, Vulliez A, Blanchet MC, Frering V, Faucheron JL, Chasserant P. Short-term Outcomes of Ambulatory Colectomy for 157 Consecutive Patients. Ann Surg. 2019 Aug;270(2):317-321. doi: 10.1097/SLA.0000000000002800.

    PubMed 29727328

  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PubMed 28097305

  • Papageorge CM, Zhao Q, Foley EF, Harms BA, Heise CP, Carchman EH, Kennedy GD. Short-term outcomes of minimally invasive versus open colectomy for colon cancer. J Surg Res. 2016 Jul;204(1):83-93. doi: 10.1016/j.jss.2016.04.020. Epub 2016 Apr 22.

    PubMed 27451872

  • Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.

    PubMed 24781574

Questions about this trial

What is this clinical trial studying?

A study testing Same-Day Colectomy in people with Colorectal and Colectomy, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Readmission (time frame: 30-Days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176715, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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