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Recruiting NCT07176715

Same-Day Colectomy: is it Safe for Patients?

No phase Interventional Colorectal Colectomy Colectomy Left/Right/Total Under Laparotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Same-Day Colectomy.
Who it may be relevant to
Registry conditions: Colorectal, Colectomy, Colectomy Left/Right/Total Under Laparotomy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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, patien

Primary outcome measures

  • Hospital Readmission [Time frame: 30-Days post-procedure]
Secondary outcome measures (10)
  • rate of surgical site infection [Time frame: 30-days Post Procedure]
  • rate of deep surgical infection [Time frame: 30-days Post Procedure]
  • rate of anastomotic leak [Time frame: 30-days Post-procedure]
  • rate of bleeding requiring transfusion [Time frame: 30-Days Post-Procedure]
  • rate of postoperative ileus [Time frame: 30-Days Post-Procedure]
  • rate of reoperation [Time frame: 30-Days Post-Procedure]
  • reintervention [Time frame: 30-Days Post-Procedure]
  • rate of acute kidney injury or renal failure [Time frame: 30-Days Post-Procedure]
  • rate of reintubation or need for prolonged ventilation [Time frame: 30-Days Post-Procedure]
  • Rate of mortality [Time frame: 30-Days Post Procedure]

Eligibility criteria

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
  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Banner University Medical Center Phoenix — Phoenix

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28097305

Identifiers

NCT: NCT07176715 · STUDY00003441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗