Fasting vs Eating Before Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Irvine
Disqualifiers: Insulin-dependent diabetes, Allergy to anesthesia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine whether eating solid food prior to undergoing a wide awake local-only no tourniquet (WALANT) procedure reduces anxiety in patients or has any effect on outcomes. Patients will be split randomly into two groups and told whether to eat or fast before their procedure. We will then compare levels of anxiety and nausea on the day of the procedure as well as satisfaction with the procedure and other outcome measures at follow-up visits. Our hypothesis is that patients who are instructed to eat before their WALANT procedure will have less anxiety, nausea, and overall higher satisfaction compared to those who are instructed to fast prior to their procedure.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Fasting, Intermittent Fasting, Continuous Calorie Energy Reduction (CER), Weight Loss Interventions, Non-fasting, Non-fasting, No fasting, Eating before surgery?
Is it safe to eat before surgery instead of fasting?
How does fasting before surgery differ from other preoperative treatments?
Fasting before surgery is unique because it involves not eating or drinking for a period before the procedure, which can improve the body's response to surgical stress and potentially shorten hospital stays. Unlike other preoperative treatments that might involve medications or dietary changes, fasting focuses on temporarily abstaining from food and fluids to prepare the body for surgery.3591011
Eligibility Criteria
This trial is for patients undergoing WALANT procedures with the lead researcher. It aims to see if eating before surgery affects anxiety, nausea, and satisfaction. People can't join if they don't meet specific criteria set by the research team.Inclusion Criteria
I am having a surgery with only local anesthesia and no tourniquet.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person or virtual)
Preoperative Evaluation
Participants undergo preoperative evaluation and are assigned to either the fasting or eating group
1 day
1 visit (in-person or virtual)
Procedure
Participants undergo the WALANT procedure and are assessed for anxiety, pain, and nausea
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the procedure, with assessments at 2 weeks and 6 weeks
6 weeks
2 visits (in-person or virtual)
Long-term Follow-up
Data collection continues for complications and outcomes up to 6 months postoperatively
6 months
Treatment Details
Interventions
- Fasting (Behavioural Intervention)
- Non-fasting (Behavioural Intervention)
Trial OverviewThe study compares two groups: one that eats solid food before a WALANT procedure and another that fasts. The goal is to measure anxiety levels, nausea on the day of surgery, and patient satisfaction during follow-up visits.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Not FastingExperimental Treatment1 Intervention
The eating group will be told specifically to eat a light meal (equivalent to two slices of toasted bread with butter and jam and one cup of coffee or juice) the morning of their surgery, within two hours of their procedure start time.
Group II: FastingActive Control1 Intervention
Patients in the fasting group will be told to avoid any food past midnight the day before their surgery and any liquids 4 hours before their scheduled surgery.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCI Health Manchester PavilionOrange, CA
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
References
Impact of a dietitian-led very low calorie diet clinic on perioperative risk for patients with obesity awaiting elective, non-bariatric surgery: A retrospective cohort study. [2023]Despite a lack of evidence that intentional weight loss reduces the risk of postoperative complications, adults with obesity are commonly asked to lose weight before elective surgery. We hypothesized that patients undertaking dietitian-led preoperative, very low calorie diet treatment could reduce perioperative surgery risks, as per validated risk scoring systems. The purpose of this study was to measure the impact of a dietitian-led preoperative very low calorie diet clinic on the American Society of Anesthesiologists physical status scores and National Surgical Quality Improvement Program Surgical Risk Calculator scores for patients with obesity awaiting non-bariatric elective surgery.
Abbreviated perioperative fasting management for elective fresh fracture surgery: guideline adherence analysis. [2022]Long-term fasting for elective surgery has been proven unnecessary based on established guidelines. Instead, preoperative carbohydrate loading 2 h before surgery and recommencing oral nutrition intake as soon as possible after surgery is recommended. This study was performed to analyze the compliance with and effect of abbreviated perioperative fasting management in patients undergoing surgical repair of fresh fractures based on current guidelines.
FASTING IN ELECTIVE SURGICAL PATIENTS: COMPARISON AMONG THE TIME PRESCRIBED, PERFORMED AND RECOMMENDED ON PERIOPERATIVE CARE PROTOCOLS. [2023]Prolonged preoperative fasting may impair nutritional status of the patient and their recovery. In contrast, some studies show that fasting abbreviation can improve the response to trauma and decrease the length of hospital stay.
The impact and safety of preoperative oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized controlled trial. [2022]Increasing evidence suggests that preoperative fasting, as was the clinical practice for many decades, might be associated with untoward consequences and that a standardized preoperative intake of nutrients might be advantageous; this is a component of the enhanced recovery after surgery (ERAS) concept. Thus, in a randomized controlled trial we compared preoperative fasting with preoperative preparation with either oral or intravenous intake of carbohydrates, minerals and water. Biochemical, psychosomatic, echocardiographic and muscle-power parameters were assessed in surgical patients with colorectal diseases during the short-term perioperative period. We also assessed the safety of peroral intake shortly before surgery.
Effect of multidisciplinary interventions in perioperative management center on duration of preoperative fasting: A single-center before-and-after study. [2022]Our aims were to clarify the actual situation regarding preoperative fasting and determine whether multidisciplinary interventions in a perioperative management center shorten the duration of preoperative fasting.
Effects of a balanced energy and high protein formula diet (Vegestart complet®) vs. low-calorie regular diet in morbid obese patients prior to bariatric surgery (laparoscopic single anastomosis gastric bypass): a prospective, double-blind randomized study. [2013]Bariatric surgery is considered the only therapeutic alternative for morbid obesity and its comorbidities. High risks factors are usually linked with this kind of surgery. In order to reduce it, we consider that losing at least 10% of overweight in Morbid Obese (MO) and a minimum of 20% in Super- Obese patients (SO) before surgery, may reduce the morbidity of the procedure. The aim of our study is to demonstrate the effectiveness and tolerance of a balanced energy formula diet at the preoperative stage, comparing it against a low calorie regular diet.
[Preoperative fasting: Instructions to patients and length of fasting - a prospective, descriptive survey]. [2017]Fasting is an important safety precaution for patients before surgery but studies indicate that excessive fasting is common. Explanations for this, including patient education related factors, are not well known. The aim of this study was to explore how long patients fast before surgery and what instructions they received, one year after the introduction of new guidelines for patients and professionals.
Elective Surgery in Adult Patients with Excess Weight: Can Preoperative Dietary Interventions Improve Surgical Outcomes? A Systematic Review. [2023]This systematic review summarises the literature regarding the impact of preoperative dietary interventions on non-bariatric surgery outcomes for patients with excess weight/obesity, a known risk factor for poor surgical outcomes. Four electronic databases were searched for non-bariatric surgery studies that evaluated the surgical outcomes of a preoperative diet that focused on weight/fat loss or improvement of liver steatosis. Meta-analysis was unfeasible due to the extreme heterogeneity of variables. Fourteen studies, including five randomised controlled trials, were selected. Laparoscopic cholecystectomy, hernia repair, and liver resection were most studied. Diet-induced weight loss ranged from 1.4 kg to 25 kg. Preoperative very low calorie diet (≤800 kcal) or low calorie diet (≤900 kcal) for one to three weeks resulted in: reduction in blood loss for two liver resection and one gastrectomy study (-27 to -411 mL, p < 0.05), and for laparoscopic cholecystectomy, reduction of six minutes in operating time (p < 0.05) and reduced difficulty of aspects of procedure (p < 0.05). There was no difference in length of stay (n = 7 studies). Preoperative ≤ 900 kcal diets for one to three weeks could improve surgical outcomes for laparoscopic cholecystectomy, liver resection, and gastrectomy. Multiple randomised controlled trials with common surgical outcomes are required to establish impact on other surgeries.
The impact of discussing preoperative fasting with patients. [2018]Patients awaiting surgery are often fasted preoperatively well in excess of the recommended fasting times. Educated perioperative practitioners were asked to discuss preoperative starvation with patients. Preoperative starvation period for clear fluids was significantly reduced from a mean of 8 hours 30 minutes in the original audit, to 6 hours 10 minutes in this study of 113 patients (p
Preoperative weight loss in patients with indication of bariatric surgery: which is the best method? [2013]Surgery is the only effective treatment for people with a body mass index (BMI) greater than 40 Kg/m² or even greater than 35 Kg/m² when some diseases like diabetes or hypertension appear. In order to minimize surgical risk and improve postoperative results, preoperative preparation it's very important. "Acute" preoperative weight loss just before surgery plays a crucial role in that preparation and can be achieved through different ways like a low calorie diet, a very low calorie diet or with the use of an intragastric balloon. The advantages or particularities of every one of them will be summarized in this article.
[Use of the method of food deprivation in preoperative care of patients with concomitant obesity]. [2006]Alimentary deprivation was used in preoperative treatment of 86 surgical patients with obesity. Body mass was reduced by 10 to 20%, on an average, and the course of concomitant diseases was corrected. Findings of clinical, instrumental, and laboratory studies showed that alimentary deprivation was well tolerated by surgical patients, improving their resistance to surgical stress.