NCT04266015

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

February 10, 2020

Last Update Submit

April 13, 2022

Conditions

FastingFeeding, Time RestrictedStress-related ProblemHead and Neck NeoplasmsCatabolic StateHyperglycemia StressMuscle WastingComplication,Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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

    7 days after free flap reconstruction

Secondary Outcomes (1)

  • Number of participants that have perioperative complications

    Start of free flap reconstruction surgery to 28 days after operation

Study Arms (2)

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

Dietary Supplement: Enteral nutrition formula

Interventions

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.

Intraoperative feeding group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced head-and-neck cancer
  • Requires radical resection, tracheostomy and free flap reconstruction surgery

You may not qualify if:

  • Anticipated total operation time \< 6h
  • Emergency operation
  • Bowel obstruction
  • Starts nasogastric feeding before operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-Da Hospital

Yanchao, Kaohsiung, 824, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 36960779DERIVED

MeSH Terms

Conditions

FastingIntermittent FastingHead and Neck NeoplasmsMuscular AtrophyPostoperative Complications

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeoplasms by SiteNeoplasmsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Chen-Fuh Lam, MD, PhD

    E-Da Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants: patients will receive general anesthesia before intervention Care providers: surgeons will be masked of the treatment group during operation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized double-blind controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Superintendent, professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

April 16, 2020

Primary Completion

January 10, 2022

Study Completion

April 13, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

TW(1)