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

Trial Summary

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 data supports the effectiveness of the treatment Early Feeding, Immediate Postoperative Oral Feeding, Early Oral Intake after oral cavity surgery?

Research shows that starting oral feeding soon after surgery can shorten hospital stays and does not increase complications for patients who have had surgery for oral cavity cancer. Early feeding is also generally preferred for surgical patients to prevent underfeeding and related complications. ^{1 2 3 4 5}

Is early feeding after surgery safe?

Research suggests that early oral feeding after surgery is generally safe and can help prevent underfeeding, which is a risk for complications. Studies on colorectal surgery show that early feeding is feasible and well-tolerated by patients. ^{1 6 7 8 9}

How is the early feeding treatment after oral cavity surgery different from other treatments?

Early feeding after oral cavity surgery is unique because it allows patients to start eating by mouth within a few days after surgery, rather than waiting 6-12 days as traditionally done. This approach can lead to a shorter hospital stay without increasing the risk of complications, making it a promising option for faster recovery. ^{1 2 4 10 11}

What is the purpose of this trial?

This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.

Research Team

Mohemmed Khan, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

ESPEN practical guideline: Clinical nutrition in surgery. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

Is early postoperative feeding feasible in elective colon and rectal surgery? [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

Early oral intake after reconstruction with a free flap for cancer of the oral cavity. [2022]

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

A randomized controlled trial of early postoperative feeding in gynecologic oncology patients undergoing intra-abdominal surgery. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. [2014]

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

Early oral feeding in patients undergoing elective colonic anastomosis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

ESPEN guideline: Clinical nutrition in surgery. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Early postoperative nutrition after elective colonic surgery]. [2014]

10. Scotland pubmed.ncbi.nlm.nih.gov

Early feeding after free flap reconstruction for oral cancer. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Early enteral feeding on esophageal cancer patients after esophageal resection and reconstruction. [2021]