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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating before a specific type of surgery, known as a WALANT procedure, can reduce anxiety and improve satisfaction. Patients will be divided into two groups: one will fast, avoiding all food and drink before surgery, while the other will eat a light meal. Researchers will compare anxiety, nausea, and satisfaction levels between the two groups. This trial is suitable for those scheduled for a WALANT procedure with the lead researcher and who do not have insulin-dependent diabetes or an allergy to local anesthesia. As an unphased trial, this study offers a unique opportunity to understand how pre-surgery eating habits might enhance patient experiences.

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 prior data suggests that this protocol is safe for patients undergoing WALANT procedures?

Research has shown that fasting before surgery might offer health benefits, such as improving certain body functions. For instance, fasting can lower Cystatin C, a protein linked to health issues. Other studies suggest that fasting or eating less can reduce blood pressure and aid in weight loss. However, these benefits do not directly relate to safety during surgery.

Fasting before surgery primarily aims to reduce risks during anesthesia. Strong evidence does not support the necessity of fasting, especially for surgeries where patients remain partially awake. Some experts argue against mandatory fasting, citing a lack of clear proof that it prevents complications.

Studies have not shown that not fasting is unsafe. Some findings suggest it might be acceptable to eat lightly before certain surgeries, though risks exist, such as inhaling food into the lungs, particularly if anesthesia is involved.

In summary, both fasting and not fasting have advantages and disadvantages, but neither approach has been proven unsafe for the type of surgery in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to pre-surgery preparation: fasting and non-fasting. Traditionally, fasting before surgery has been the norm to reduce the risk of complications like aspiration. However, this trial is investigating whether allowing patients to eat a light meal before surgery could be just as safe while potentially improving their comfort and energy levels. By comparing fasting with a non-fasting protocol, researchers aim to find out if there’s a better way to prepare patients for surgery that could enhance their overall experience and outcomes.

What evidence suggests that this trial's treatments could be effective for reducing anxiety before surgery?

This trial will compare fasting with eating before surgery. Research has shown that short-term fasting can lower levels of Cystatin C, a marker related to metabolic problems, and improve recovery after surgeries like weight-loss surgery. This suggests that fasting might help the body prepare for surgery by reducing certain risks. However, strong evidence does not support fasting as a way to reduce anxiety or increase satisfaction during minor surgeries. Participants in the non-fasting arm, who will eat before surgery, may experience benefits related to comfort and anxiety. Early findings suggest that having a light meal might reduce anxiety, but more research is needed to confirm this. ^{1 2 4 6 7}

Who Is on the Research Team?

Jesse Kaplan, MD

Principal Investigator

UCI School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5722208/

Is Overnight Fasting before Surgery Too Much or Not ... Current preoperative fasting is likely too short for benefits. Short-term fasting or restriction of food intake (days to a week) may be ...

2. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2642

Can caloric restriction improve outcomes of elective surgeries? Fasting has been shown to reduce Cystatin C, a biomarker elevated in patients with metabolic syndrome, and decreased after bariatric surgery.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10098946/

A meta‐analysis comparing the effectiveness of alternate day ... Our results ranked alternate day fasting/modified ADF as the regimen with the highest efficacy for weight loss compared with the 5:2 diet and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04526847

Intermittent Fasting Compared to Continuous Energy ... The primary outcome of this study will be the change in reduction of body weight between IER diet using 2-day severe energy-restricted with 5 days of habitual ...

5. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1748-4

Intermittent versus continuous energy restriction on weight ... Both intermittent and continuous energy restriction achieved a comparable effect in promoting weight-loss and metabolic improvements.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... Both time-restricted eating and daily calorie restriction were associated with reduced systolic and diastolic blood pressure over 12 months, ...

7. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/intermittent-fasting-what-is-it-and-how-does-it-work

Intermittent Fasting: What is it, and how does it work? In animals, intermittent fasting reduced tissue damage in surgery and improved results. Is intermittent fasting safe? Some people try intermitting fasting for ...