Same-Day Colectomy: is it Safe for Patients?

NCT07176715 | Recruiting

• 1 other identifier: STUDY00003441
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal; Colectomy; Colectomy Left/Right/Total Under Laparotomy

Keywords

Same Day Colectomy; outpatient Colectomy

Outcome Measures

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

  30-Days post-procedure

Secondary Outcomes (10)

• rate of surgical site infection

  30-days Post Procedure

• rate of deep surgical infection

  30-days Post Procedure

• rate of anastomotic leak

  30-days Post-procedure

• rate of bleeding requiring transfusion

  30-Days Post-Procedure

• rate of postoperative ileus

  30-Days Post-Procedure

Study Arms (1)

Same Day Colectomy

EXPERIMENTAL

Other: Same-Day Colectomy

Interventions

Same-Day Colectomy 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

Also known as: Outpatient Colectomy

Same Day Colectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 33349570 BACKGROUND

• 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.

  PMID: 33094353 BACKGROUND

• 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.

  PMID: 34970026 BACKGROUND

• 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.

  PMID: 35419638 BACKGROUND

• 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.

  PMID: 25661787 BACKGROUND

• 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.

  PMID: 35570059 BACKGROUND

• 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.

  PMID: 29727328 BACKGROUND

• 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.

  PMID: 28097305 BACKGROUND

• 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.

  PMID: 27451872 BACKGROUND

• 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.

  PMID: 24781574 BACKGROUND

Study Officials

• Eugene Kim, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Clinical Series

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)