Fasting vs Eating Before Surgery

Overseen By Mikhail Pakvasa, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Insulin-dependent diabetes, Allergy to anesthesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

134 Participants Needed

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?

Some studies suggest that shortening fasting times before surgery can improve recovery and reduce hospital stays. Additionally, preoperative intake of nutrients, as part of enhanced recovery protocols, may be beneficial compared to traditional fasting. ^{1 2 3 4 5}

Is it safe to eat before surgery instead of fasting?

Research suggests that eating before surgery, instead of fasting, can be safe and might even improve recovery. Studies show that having nutrients before surgery can help reduce blood loss and improve surgical outcomes without increasing hospital stay. ^{3 4 6 7 8}

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. ^{3 5 9 10 11}

Research Team

Jesse Kaplan, MD

Principal Investigator

UCI School of Medicine

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.

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
• Non-fasting

Trial Overview The 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

Group I: Not Fasting Experimental Treatment 1 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: Fasting Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

A dietitian-led preoperative very low calorie diet resulted in clinically significant weight loss (average of 7.1 kg) for 141 patients with obesity, which improved their American Society of Anesthesiologists scores and reduced estimated surgical risks.

The median risk of serious postoperative complications decreased from 4.8% to 3.9% and the risk of any complications from 6% to 5.1%, indicating that this dietary intervention may enhance safety for patients undergoing non-bariatric elective surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

In a study of 306 patients undergoing surgery for fresh fractures, 71.6% complied with preoperative carbohydrate loading, and 93.5% started drinking clear liquids within 2 hours after surgery, indicating effective adherence to updated fasting guidelines.

The median fasting times were significantly reduced postoperatively, with 70.3% of patients reporting no thirst and 74.2% reporting no hunger, suggesting that the abbreviated fasting management improved patient comfort without any adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated perioperative fasting management for elective fresh fracture surgery: guideline adherence analysis. Sun, ZJ., Sun, X., Huo, Y., et al.[2022]

In a study of 65 patients undergoing elective digestive surgeries, the actual fasting time before surgery averaged 16 hours, which was significantly longer than the prescribed 11 hours, indicating a need for better adherence to fasting protocols.

Prolonged fasting led to increased discomfort from hunger and thirst, especially in the postoperative period, suggesting that implementing a preoperative fasting abbreviation protocol could enhance patient recovery and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FASTING IN ELECTIVE SURGICAL PATIENTS: COMPARISON AMONG THE TIME PRESCRIBED, PERFORMED AND RECOMMENDED ON PERIOPERATIVE CARE PROTOCOLS. Francisco, SC., Batista, ST., Pena, Gd.[2023]

In a study of 221 elective colorectal surgery patients, preoperative intake of a carbohydrate-rich solution (group C) significantly improved postoperative cardiac function and psychosomatic conditions compared to traditional fasting (group A).

Preoperative fasting was found to have no benefits and was associated with increased insulin resistance, while the oral intake shortly before surgery did not increase gastric residual volume, indicating it is safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact and safety of preoperative oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized controlled trial. Kaska, M., Grosmanová, T., Havel, E., et al.[2022]

A study involving 481 patients undergoing elective surgery showed that implementing a perioperative management center significantly reduced the duration of preoperative fasting compared to traditional protocols.

Patients in the perioperative management center (Group C) had a fasting duration of 180 minutes, which was shorter than both Group A (243 minutes) and Group B (213 minutes), indicating that multidisciplinary interventions can enhance compliance and efficiency in preoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary interventions in perioperative management center on duration of preoperative fasting: A single-center before-and-after study. Komatsu, S., Yamashita, C., Yatabe, T., et al.[2022]

A study of 120 morbidly obese patients showed that those on a balanced energy formula diet before bariatric surgery experienced greater improvements in weight loss, BMI, blood pressure, and glucose levels compared to those on a low-calorie regular diet.

The findings suggest that preoperative preparation with a balanced energy formula diet can significantly reduce surgical risks and improve overall health outcomes for morbidly obese patients, highlighting its efficacy in managing comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Carbajo, MA., Castro, MJ., Kleinfinger, S., et al.[2013]

In a study of 193 surgical patients, the average fasting time was found to be unnecessarily long, with 13.6 hours for solid food and 8.8 hours for clear fluids, indicating a need for better management of preoperative fasting guidelines.

Only 27% of patients received instructions that aligned with the new fasting guidelines, and those who received both verbal and written information fasted shorter on clear fluids, highlighting the importance of consistent patient education in reducing excessive fasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative fasting: Instructions to patients and length of fasting - a prospective, descriptive survey]. Ingadottir, B., Olafsdottir, AM., Sveinsdottir, H., et al.[2017]

Preoperative very low calorie diets (≤800 kcal) or low calorie diets (≤900 kcal) for one to three weeks can significantly improve surgical outcomes for patients with excess weight/obesity, including reduced blood loss and shorter operating times in procedures like laparoscopic cholecystectomy and liver resection.

The review included 14 studies, highlighting that while these dietary interventions can enhance certain surgical outcomes, more randomized controlled trials are needed to assess their impact on a broader range of surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective Surgery in Adult Patients with Excess Weight: Can Preoperative Dietary Interventions Improve Surgical Outcomes? A Systematic Review. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

A study involving 113 patients showed that educating perioperative practitioners about preoperative fasting significantly reduced the fasting time for clear fluids from an average of 8 hours and 30 minutes to 6 hours and 10 minutes (p < 0.001).

Enhancing patient understanding of preoperative fasting guidelines can lead to better compliance with recommended fasting times, which is important for patient safety and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of discussing preoperative fasting with patients. Khoyratty, S., Din, AH., Spendlove, R., et al.[2018]

A literature review involving 371 patients indicated that very low calorie diets and intragastric balloon placements resulted in greater weight loss compared to low calorie diets, although they were associated with slightly higher morbidity and costs.

Very low calorie diets were found to be more effective and quicker for preoperative weight loss than low calorie diets, while also being cheaper and having fewer side effects compared to the intragastric balloon option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative weight loss in patients with indication of bariatric surgery: which is the best method? Adrianzén Vargas, M., Cassinello Fernández, N., Ortega Serrano, J.[2013]

In a study involving 86 surgical patients with obesity, preoperative alimentary deprivation led to an average body mass reduction of 10 to 20%, which may enhance surgical outcomes.

The treatment was well tolerated by patients and contributed to improved management of concurrent health issues, indicating its potential to increase patients' resilience to surgical stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the method of food deprivation in preoperative care of patients with concomitant obesity]. Zhdanov, GG., Shubin, AG., Matveev, AD.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Abbreviated perioperative fasting management for elective fresh fracture surgery: guideline adherence analysis. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

FASTING IN ELECTIVE SURGICAL PATIENTS: COMPARISON AMONG THE TIME PRESCRIBED, PERFORMED AND RECOMMENDED ON PERIOPERATIVE CARE PROTOCOLS. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

The impact and safety of preoperative oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized controlled trial. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Effect of multidisciplinary interventions in perioperative management center on duration of preoperative fasting: A single-center before-and-after study. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

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]

7. Iceland pubmed.ncbi.nlm.nih.gov

[Preoperative fasting: Instructions to patients and length of fasting - a prospective, descriptive survey]. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Elective Surgery in Adult Patients with Excess Weight: Can Preoperative Dietary Interventions Improve Surgical Outcomes? A Systematic Review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The impact of discussing preoperative fasting with patients. [2018]

10. Spain pubmed.ncbi.nlm.nih.gov

Preoperative weight loss in patients with indication of bariatric surgery: which is the best method? [2013]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Use of the method of food deprivation in preoperative care of patients with concomitant obesity]. [2006]