Clinical trial NCT03189550: Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
Official title: Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Surgery
Quality Improvement
Perioperative Care
ERAS
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2017-06-16
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center

Brief summary: Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

Detailed description: Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This large quality improvement project will compare outcomes after standard perioperative practice with those after the implementation of a multi-modal evidence based care pathway, including standardized preoperative preparation, perioperative goal-directed fluid therapy (GFDT), multi-modal perioperative pain management, post operative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.

Exclusion Criteria:

* Age \<18 years
* Weight \<40 kg

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: Up to 30 days postoperative
Secondary outcomes:
measure: ICU length of stay
timeFrame: Up to 30 days postoperative
measure: Time on ventilator
timeFrame: Up to 30 days postoperative
measure: Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS)
timeFrame: Up to 30 days postoperative
measure: Post operative anti emetic consumption
timeFrame: Up to 30 days postoperative
measure: Occurrence of postoperative complications
timeFrame: Up to 30 days postoperative
measure: Analgesia consumption
timeFrame: Up to 30 days postoperative
measure: Cardiac Index
timeFrame: 1 day
measure: Stroke volume
timeFrame: 1 day
measure: Systemic vascular resistance
timeFrame: 1 day
measure: Heart rate
timeFrame: 1 day
measure: Hospital Length of stay (days)
timeFrame: Up to 30 days post operative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew D McEvoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McEvoy MD, Wanderer JP, Shi Y, Ramanujan KS, Geiger TM, Shotwell MS, Shaw AD, Hawkins AT, Martin BJ, Mythen MG, Sandberg WS. The effect of adding goal-directed hemodynamic management for elective patients in an established enhanced recovery program for colorectal surgery: results of quasi-experimental pragmatic trial. Perioper Med (Lond). 2020 Nov 23;9(1):35. doi: 10.1186/s13741-020-00163-3.