Same-Day Colectomy: is it Safe for Patients?

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Hospital Readmission [Срок оценки: 30-Days post-procedure]

Вторичные конечные точки (10)

• rate of surgical site infection [Срок оценки: 30-days Post Procedure]
• rate of deep surgical infection [Срок оценки: 30-days Post Procedure]
• rate of anastomotic leak [Срок оценки: 30-days Post-procedure]
• rate of bleeding requiring transfusion [Срок оценки: 30-Days Post-Procedure]
• rate of postoperative ileus [Срок оценки: 30-Days Post-Procedure]
• rate of reoperation [Срок оценки: 30-Days Post-Procedure]
• reintervention [Срок оценки: 30-Days Post-Procedure]
• rate of acute kidney injury or renal failure [Срок оценки: 30-Days Post-Procedure]
• rate of reintubation or need for prolonged ventilation [Срок оценки: 30-Days Post-Procedure]
• Rate of mortality [Срок оценки: 30-Days Post Procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Banner University Medical Center Phoenix — Phoenix

Публикации

• 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

Идентификаторы

NCT: NCT07176715 · STUDY00003441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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