Early Feeding After Oral Cavity Surgery

Overseen By Catharine Kappauf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Prior oral surgery, Dysphagia, Brain injury, others

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

Compensation: Varies

Number of Visits: Unknown

89 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether individuals who have undergone oral cavity reconstructive surgery can safely begin eating immediately after surgery, a practice known as "Early Feeding." The primary goal is to determine if early eating affects the likelihood of developing an orocutaneous fistula (a small hole that can form between the mouth and skin) compared to waiting several days before eating. Researchers will monitor participants for 30 days to check for any signs of infection or issues with the surgery site. Individuals undergoing this type of surgery for the first time, without pre-existing swallowing issues, are suitable candidates for this trial. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance post-surgery recovery practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that early feeding after oral cavity surgery is safe?

Research has shown that starting to eat soon after surgery is usually safe and well-tolerated. In one study of patients who underwent stomach or intestinal surgeries, 79.6% were able to eat within the first four days post-operation. Another study found that early eating can speed up recovery and may reduce hospital stays.

Guidelines also indicate that early eating is safe for patients with certain surgeries. For those considering joining a trial like this, evidence suggests that early feeding is generally safe for most people and might even aid in quicker recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early feeding after oral cavity surgery because it could lead to faster recovery times compared to the traditional approach of delaying food intake. Typically, patients are kept on a restricted diet or fed via tube until they are well into their healing process, which can be uncomfortable and inconvenient. By allowing patients to eat sooner, this method might improve their nutritional intake and enhance healing, potentially reducing hospital stays and improving overall patient satisfaction. This approach challenges the existing norms and could represent a significant shift in post-surgical care for oral cavity operations.

What evidence suggests that early feeding is effective after oral cavity surgery?

Research has shown that starting to eat soon after oral cavity surgery can be safe and manageable. In one study, 79.6% of patients who underwent similar surgeries ate within the first four days without problems. Participants in this trial will join an Early Feeding Arm, beginning to eat soon after surgery. Early eating might also speed up the first bowel movement and reduce hospital stay length. Another study found that early eating is safe and beneficial for patients with upper digestive issues. These findings suggest that eating soon after surgery could aid recovery after oral cavity surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Mohemmed Khan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need reconstructive surgery in the oral cavity and can consent in English, Spanish, or Mandarin. It's not for those with prior major oral surgery, radiation to the mouth, unable to understand the study, or have swallowing issues.

Inclusion Criteria

Patients who have received surgery to rebuild their oral cavity using their own tissue can participate.

You speak either English, Spanish or Mandarin Chinese.

Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

Patients having undergone prior major oral cavity surgery or radiation to the oral cavity (also known as surgical salvage patients).

Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis.

Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, pregnant women, prisoners, pregnant women)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo oral cavity reconstructive surgery and are allowed to eat by mouth on post-operative day 1

1 week

Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness, including signs of surgical site infection, wound breakdown, and swallow function

30 days

Several clinical evaluations

What Are the Treatments Tested in This Trial?

Interventions

• Early Feeding

Trial Overview The study tests if eating right after oral cavity reconstruction is as safe as waiting several days before eating. Patients' healing and swallowing function are monitored for a month post-surgery at Mount Sinai Hospital locations.

How Is the Trial Designed?

Group I: Early Feeding Arm Experimental Treatment 1 Intervention

Early Feeding Group

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Early oral feeding after colorectal surgery is safe and well-tolerated by 75% of patients, leading to quicker recovery times for passing flatus and stool compared to traditional feeding methods.

Patients who started early feeding had a shorter hospital stay (6.2 days) compared to those who followed the traditional approach (6.9 days), although factors like operative time and blood loss affected how well patients tolerated early feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early oral feeding in patients undergoing elective colonic anastomosis. El Nakeeb, A., Fikry, A., El Metwally, T., et al.[2022]

In a study of 190 patients undergoing elective open colorectal surgery, early oral feeding was tolerated by 79.6% of patients within the first four days, demonstrating its feasibility and safety.

While early feeding led to a higher incidence of vomiting and nasogastric tube insertion (21.5%), overall complications were similar between early feeding and traditional methods, indicating that early oral intake can be a viable option post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is early postoperative feeding feasible in elective colon and rectal surgery? Ortiz, H., Armendariz, P., Yarnoz, C.[2022]

Early oral feeding is crucial for surgical patients, particularly those at nutritional risk, as it helps prevent malnutrition and reduces the likelihood of postoperative complications.

The guidelines emphasize starting nutritional therapy as soon as a nutritional risk is identified and re-establishing oral feeding promptly after surgery to support recovery and metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESPEN guideline: Clinical nutrition in surgery. Weimann, A., Braga, M., Carli, F., et al.[2022]

Early oral feeding is crucial for surgical patients to prevent malnutrition and underfeeding, which can lead to postoperative complications, especially in those at nutritional risk after major surgeries like upper gastrointestinal procedures.

The guidelines emphasize integrating nutrition into perioperative care, including minimizing preoperative fasting, starting oral feeding as soon as possible after surgery, and addressing nutritional risks immediately to enhance recovery and metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESPEN practical guideline: Clinical nutrition in surgery. Weimann, A., Braga, M., Carli, F., et al.[2023]

A meta-analysis of seven trials involving 587 patients found that early oral feeding after elective colorectal surgery significantly reduced the length of hospital stay by an average of 1.58 days compared to traditional feeding methods.

Early oral feeding also led to a decrease in total postoperative complications, with a relative risk reduction of 30%, while showing no significant differences in serious complications like anastomotic dehiscence or pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. Zhuang, CL., Ye, XZ., Zhang, CJ., et al.[2014]

In a study of 41 esophageal cancer patients who underwent minimally invasive surgery, early postoperative oral feeding (EOF) was found to significantly reduce the length of hospital stay and the time until patients could start liquid food compared to simple tube feeding (STF).

While EOF did not increase the risk of complications or mortality, it was associated with lower levels of C-reactive protein (CRP), indicating a potential benefit in reducing inflammation post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral feeding on esophageal cancer patients after esophageal resection and reconstruction. Liao, M., Xia, Z., Huang, P., et al.[2021]

Introducing oral intake within 6 days after surgery for oral cavity cancer patients significantly shortened their hospital stay compared to those who started feeding later, indicating a potential benefit for postoperative recovery.

Early oral feeding did not increase complications, such as orocutaneous fistula, suggesting it is a safe practice for patients undergoing resection and reconstruction with free flaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early oral intake after reconstruction with a free flap for cancer of the oral cavity. Guidera, AK., Kelly, BN., Rigby, P., et al.[2022]

A study involving 200 gynecologic oncology patients showed that early oral feeding after intra-abdominal surgery is safe and well tolerated, with no significant differences in major complications between early and traditional feeding groups.

Although more patients in the early feeding group experienced nausea, the overall recovery metrics, such as time to start clear liquids and regular diets, and length of hospital stay, were significantly better compared to those who followed traditional feeding protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery. Pearl, ML., Valea, FA., Fischer, M., et al.[2019]

In a study of 10 patients who underwent surgery for oral cancer, early oral feeding was safely initiated, with half of the patients able to tolerate clear fluids by the first postoperative day and most managing a pureed diet by day four.

Early oral feeding did not lead to any complications and resulted in a mean hospital stay of 11 days, suggesting that this approach could enhance recovery without increasing risks compared to traditional practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early feeding after free flap reconstruction for oral cancer. McAuley, D., Barry, T., McConnell, K., et al.[2022]

Immediate postoperative oral feeding of a regular diet after elective open colorectal surgery is safe, with a low morbidity rate of 12.5% and mortality rate of 2%.

The majority of patients (85%) tolerated early oral feeding well, and this approach also shortened the average postoperative hospital stay to 10.6 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early postoperative nutrition after elective colonic surgery]. Brönnimann, S., Studer, M., Wagner, HE.[2014]

Early postoperative oral feeding is becoming the standard of care for patients undergoing major surgeries, including gynecologic and colorectal procedures, despite limited randomized clinical trial support.

The shift towards allowing early oral feeding, even after upper gastrointestinal surgeries like hepatectomy and gastrectomy, is based on the belief that it is equally safe or potentially superior to traditional feeding regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new concept of the postoperative oral feeding regimen after upper gastrointestinal surgery in the laparoscopic era]. Fukushima, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10973317/

Early oral feeding and its impact on postoperative ... This study assessed the association between the timing of oral feeding (early vs. late) and postoperative complications and length of hospital stay among these ...

2. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2-2021-71528

Early Feeding After Oral Cavity Surgery In a study of 190 patients undergoing elective open colorectal surgery, early oral feeding was tolerated by 79.6% of patients within the first four days, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468785524004853

Immediate oral feeding after free-flap reconstruction of the ... Among patients in the SOF group, 35 (34 %) patients did not resume oral feeding within 10 post-operative days and were classed in the DOF group. Please refer to ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1369141/full

The effect of early oral postoperative feeding on ... In 34 trials, our findings suggest that early oral feeding may reduce the time to the first defecation and flatus while reducing the length of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0020748923002456/pdf

Optimal time to initiate early oral feeding in postoperative ... Early oral feeding is safe, tolerable, and effective in postoperative patients with upper gastrointestinal malignancies. •. The optimal time to initiate early ...

6. cureus.com cureus.com/articles/256285-the-outcome-of-early-oral-feeding-following-elective-gastrointestinal-surgery

The Outcome of Early Oral Feeding Following Elective ... In this study, we found EOF to enhance early recovery and reduce hospital stays in comparison to TOF. Nevertheless, there are certain ...