FastingNCT04266015
Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery
A study testing Enteral nutrition formula in people with Fasting and Feeding, Time Restricted, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
Perioperative fasting remains a common clinical practice in surgical patients to prevent the development of postoperative anesthesia- and surgical-related complications. Clinical observational studies indicated that the combination catabolic effects resulted from prolonged perioperative fasting and profound surgical… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Fasting, Feeding, Time Restricted, Stress-related Problem
- What is being tested?
- Enteral nutrition formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2020to 13 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced head-and-neck cancer
- Requires radical resection, tracheostomy and free flap reconstruction surgery
Who cannot join
- Anticipated total operation time < 6h
- Emergency operation
- Bowel obstruction
- Starts nasogastric feeding before operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Intraoperative Feeding to Ameliorate Catabolic Response in Free Flap Reconstruction Surgery for Head-and-neck Cancer Defect
Perioperative fasting remains a common clinical practice in surgical patients to prevent the development of postoperative anesthesia- and surgical-related complications. Clinical observational studies indicated that the combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase, leading to the development of severe complications. Furthermore, prolonged gastrointestinal fasting is associated with microbial translocation that deteriorates the early recovery after surgery. This clinical trial anticipates in determining the beneficial effect of intraoperative feeding to improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.
Read the detailed description
Perioperative fasting remains a common clinical practice in surgical patients, aiming to prevent pulmonary aspiration during anesthesia induction, improve bowel preparation, and ameliorate the development of postoperative nausea/vomiting or other surgical-related complications. Major head-and-neck tumor excision and reconstruction surgery is one of the most time-consuming surgeries that usually takes more than 12 h to complete. In addition to the preoperative fasting and postoperative recovery time periods, most of these patients will be fasted for more than 24-36 h before they are fed via nasogastric tubes in the postoperative care units. The combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase. These catabolic responses may lead to the development of post-operative surgical site infection, delayed wound healing, re-intervention, cardiac arrest, and death in diabetic and non-diabetic patients. Furthermore, prolonged gastrointestinal fasting is associated with dehydration, perturbed gut integrity/permeability (leaky gut) and microbial (bacterial) translocation that deteriorates the early recovery after reconstruction surgery. The aim of this clinical trial is to test the effect of intraoperative feeding in patients receiving head-and-neck tumor excision and reconstruction surgery, and anticipate that reduction of perioperative fasting time may improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.
This single-center clinical trial will be undertaken in a randomized, double-blind, placebo-controlled fashion, in which patients with advanced head-and-neck tumor who are scheduled for extended tumor resection and free-flap reconstruction will be randomly assigned to receive control (no intraoperative feeding) or intraoperative feeding group. Feeding via the nasogastric (NG) tube will start after the establishment of tracheostomy and completion of tumor resection at fusion rate of 10-30 ml/h (feeding diet 1 Kcal/ml and 0.04 g protein/ml). This trial anticipates in detecting differences in intraoperative hemodynamic stability and development of major postoperative complications, including delayed wound healing, surgical site infections and insulin-resistant hyperglycemia between controls and intraoperative feeding group. The outcomes of this clinical trial may provide fundamental evidence for vigorous enteric nutrition and energy support during prolonged high surgical stress operation.
- Conditions
- Fasting, Feeding, Time Restricted, Stress-related Problem, Head and Neck Neoplasms, Catabolic State, Hyperglycemia Stress
- Being tested
- Enteral nutrition formula
- Medical subject headings
- Fasting, Intermittent Fasting, Head and Neck Neoplasms, Muscular Atrophy, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutrition formulaDietary supplement
Intervention group will receive nasogastric feeding with commercially available liquid enteral diet (250 ml/can, Kcal/ml, 10.4 g protein/can) during free flap reconstruction at feeding rates 10-30 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients assigned to control group will not receive feeding via the nasogastric tube during operation |
| Intraoperative feeding group | Experimental | Patients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation Receives: Dietary Supplement: Enteral nutrition formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have reconstruction flap failure after operation
The definition of flap failure includes vascular occlusion of flap, surgical wound infection or poor healing that requires surgical reintervention
Measured: 7 days after free flap reconstruction
Secondary outcomes (1)
Number of participants that have perioperative complications
The definition of composite perioperative complications during and after operation, include intraoperative hemodynamic stability (hypotension and requirement of inotropes), postoperative insulin sensitivity, glycemic control, skeletal muscle wasting, inflammatory cytokine profiles, length of hospital stay, re-intervention, other postoperative complications, mortality during hospital stay
Measured: Start of free flap reconstruction surgery to 28 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start16 Apr 2020
- Primary completion10 Jan 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tu, Yuan-Kun, E-DA Hospital
- Investigators
- Chen-Fuh Lam, MD, PhD, Principal investigator, E-Da Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266015
- Sponsor's protocol ID
- EMRP71108N
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hwang TZ, Wang YM, Jeng SF, Lee YC, Chen TS, Su SY, Huang CC, Lam CF. Intraoperative Enteral Nutrition Feeding in Free-Flap Healing after Reconstruction Surgery for Head and Neck Cancers. Otolaryngol Head Neck Surg. 2023 Oct;169(4):843-851. doi: 10.1002/ohn.335. Epub 2023 Mar 24.
PubMed 36960779
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Intraoperative Feeding to Ameliorate Catabolic Response in Free Flap Reconstruction Surgery for Head-and-neck Cancer Defect
- ClinicalTrials.gov ID
- NCT04266015
- Acronym / sponsor ID
- EMRP71108N
- Conditions
- Fasting, Feeding, Time Restricted, Stress-related Problem, Head and Neck Neoplasms, Catabolic State, Hyperglycemia Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative fasting remains a common clinical practice in surgical patients to prevent the development of postoperative anesthesia- and surgical-related complications. Clinical observational studies indicated that the combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase, leading to the development of severe complications. Furthermore, prolonged gastrointestinal fasting is associated with microbial translocation that deteriorates the early recovery after surgery. This clinical trial anticipates in determining the beneficial effect of intraoperative feeding to improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.
Detailed description
Perioperative fasting remains a common clinical practice in surgical patients, aiming to prevent pulmonary aspiration during anesthesia induction, improve bowel preparation, and ameliorate the development of postoperative nausea/vomiting or other surgical-related complications. Major head-and-neck tumor excision and reconstruction surgery is one of the most time-consuming surgeries that usually takes more than 12 h to complete. In addition to the preoperative fasting and postoperative recovery time periods, most of these patients will be fasted for more than 24-36 h before they are fed via nasogastric tubes in the postoperative care units. The combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase. These catabolic responses may lead to the development of post-operative surgical site infection, delayed wound healing, re-intervention, cardiac arrest, and death in diabetic and non-diabetic patients. Furthermore, prolonged gastrointestinal fasting is associated with dehydration, perturbed gut integrity/permeability (leaky gut) and microbial (bacterial) translocation that deteriorates the early recovery after reconstruction surgery. The aim of this clinical trial is to test the effect of intraoperative feeding in patients receiving head-and-neck tumor excision and reconstruction surgery, and anticipate that reduction of perioperative fasting time may improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.
This single-center clinical trial will be undertaken in a randomized, double-blind, placebo-controlled fashion, in which patients with advanced head-and-neck tumor who are scheduled for extended tumor resection and free-flap reconstruction will be randomly assigned to receive control (no intraoperative feeding) or intraoperative feeding group. Feeding via the nasogastric (NG) tube will start after the establishment of tracheostomy and completion of tumor resection at fusion rate of 10-30 ml/h (feeding diet 1 Kcal/ml and 0.04 g protein/ml). This trial anticipates in detecting differences in intraoperative hemodynamic stability and development of major postoperative complications, including delayed wound healing, surgical site infections and insulin-resistant hyperglycemia between controls and intraoperative feeding group. The outcomes of this clinical trial may provide fundamental evidence for vigorous enteric nutrition and energy support during prolonged high surgical stress operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized double-blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients assigned to control group will not receive feeding via the nasogastric tube during operation |
| Intraoperative feeding group | Experimental | Dietary Supplement: Enteral nutrition formulaPatients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced head-and-neck cancer
- Requires radical resection, tracheostomy and free flap reconstruction surgery
Key exclusion criteria (4 listed)
- Anticipated total operation time < 6h
- Emergency operation
- Bowel obstruction
- Starts nasogastric feeding before operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutrition formulaIntervention group will receive nasogastric feeding with commercially available liquid enteral diet (250 ml/can, Kcal/ml, 10.4 g protein/can) during free flap reconstruction at feeding rates 10-30 ml/h. | Dietary supplement | Intraoperative feeding group |
Primary outcome
Number of participants that have reconstruction flap failure after operation
Time frame: 7 days after free flap reconstruction
The definition of flap failure includes vascular occlusion of flap, surgical wound infection or poor healing that requires surgical reintervention
1 secondary outcome
Number of participants that have perioperative complications
Time frame: Start of free flap reconstruction surgery to 28 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 36960779Hwang TZ, Wang YM, Jeng SF, Lee YC, Chen TS, Su SY, Huang CC, Lam CF. Intraoperative Enteral Nutrition Feeding in Free-Flap Healing after Reconstruction Surgery for Head and Neck Cancers. Otolaryngol Head Neck Surg. 2023 Oct;169(4):843-851. doi: 10.1002/ohn.335. Epub 2023 Mar 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Fuh Lam, MD, PhD principal investigator
E-Da Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition formula in people with Fasting and Feeding, Time Restricted, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have reconstruction flap failure after operation (time frame: 7 days after free flap reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.