Same-Day Colectomy: is it Safe for Patients?

NCT ID: NCT07176715

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2030-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Colectomy Colectomy Left/Right/Total Under Laparotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Same Day Colectomy

Group Type EXPERIMENTAL

Same-Day Colectomy

Intervention Type OTHER

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

Interventions

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Same-Day 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

Intervention Type OTHER

Other Intervention Names

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Outpatient Colectomy

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Eugene Kim

Assistant Clinical Professor, Clinical Series

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Crystal Gonzalez, MSW

Role: primary

602-255-7553

Elena Young

Role: backup

6022557553

References

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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.

Reference Type BACKGROUND
PMID: 33349570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33094353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34970026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35419638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25661787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35570059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29727328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28097305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27451872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24781574 (View on PubMed)

Other Identifiers

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STUDY00003441

Identifier Type: -

Identifier Source: org_study_id

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