Time to Feeding After PEG Tube Placement.

NCT04627844 | Unknown Phase 4

• 1 other identifier: 1656460-1
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trauma patients who require Percutaneous Endoscopic Gastrostomy (PEG) tube placement for feeding and who consent to be in the study will be randomized to receive feeding at either 6 hours after PEG placement as is routinely done or at 0 hours after PEG placement.

Conditions

Feeding Tube Complication

Outcome Measures

Primary Outcomes (1)

• Severe complication

  Number of patients with a complication requiring return to operating room

  Typically up to 4 weeks

Secondary Outcomes (1)

• Minor complication

  Through study completion, an expected average of one year

Study Arms (2)

Delayed Feeds

PLACEBO COMPARATOR

Patients will receive tube feeds beginning at 6 hours after PEG tube placement. This is our institutions current practice Intervention Type: Dietary

Dietary Supplement: Delayed Feeding

Immediate Feeds

EXPERIMENTAL

Patients will receive tube feeds beginning immediately after PEG tube placement. Intervention Type: Dietary

Dietary Supplement: Immediate Feeding

Interventions

Immediate Feeding DIETARY_SUPPLEMENT

Standard tube feeds begun at an earlier time point

Immediate Feeds

Delayed Feeding DIETARY_SUPPLEMENT

Standard tube feeds begun at delayed time point

Delayed Feeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who require PEG tube placement for feeding by the Trauma/Acute Care Surgery at our institution who are able to provide consent or whose legally authorized representative is able to provide consent for the patient.

You may not qualify if:

• Patients not receiving PEG placement
• Patients receiving PEG tube placement by a member of a different hospital service
• Patients under the age of 18 years old

Sponsors & Collaborators

• Augusta University: lead

Related Publications (7)

• Bechtold ML, Matteson ML, Choudhary A, Puli SR, Jiang PP, Roy PK. Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. Am J Gastroenterol. 2008 Nov;103(11):2919-24. doi: 10.1111/j.1572-0241.2008.02108.x. Epub 2008 Aug 21.

  PMID: 18721239 BACKGROUND

• Choudhry U, Barde CJ, Markert R, Gopalswamy N. Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding. Gastrointest Endosc. 1996 Aug;44(2):164-7. doi: 10.1016/s0016-5107(96)70134-7.

  PMID: 8858322 BACKGROUND

• Cristian D, Poalelungi A, Anghel A, Burcos T, Grigore R, Bertesteanu S, Richiteanu G, Grama F; -. Prophylactic Percutaneous Endoscopic Gastrostomy (PEG) - The Importance of Nutritonal Support in Patients with Head and Neck Cancers (HNCs) or Neurogenic Dysphagia (ND). Chirurgia (Bucur). 2015 Mar-Apr;110(2):129-36.

  PMID: 26011834 BACKGROUND

• Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013.

  PMID: 1616387 BACKGROUND

• McCarter TL, Condon SC, Aguilar RC, Gibson DJ, Chen YK. Randomized prospective trial of early versus delayed feeding after percutaneous endoscopic gastrostomy placement. Am J Gastroenterol. 1998 Mar;93(3):419-21. doi: 10.1111/j.1572-0241.1998.00419.x.

  PMID: 9517650 BACKGROUND

• Rahnemai-Azar AA, Rahnemaiazar AA, Naghshizadian R, Kurtz A, Farkas DT. Percutaneous endoscopic gastrostomy: indications, technique, complications and management. World J Gastroenterol. 2014 Jun 28;20(24):7739-51. doi: 10.3748/wjg.v20.i24.7739.

  PMID: 24976711 BACKGROUND

• Szary NM, Arif M, Matteson ML, Choudhary A, Puli SR, Bechtold ML. Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. J Clin Gastroenterol. 2011 Apr;45(4):e34-8. doi: 10.1097/MCG.0b013e3181eeb732.

  PMID: 20733512 BACKGROUND

Central Study Contacts

Andrew Lawson, DO

CONTACT

540-998-2212; andlawson@augusta.edu

Chase J Wehrle, BA

CONTACT

912-704-6536; cwehrle@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Trauma/Critical Care, General Surgery

Model Details: Patients will be randomized to receive feeding beginning at two time points.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: November 13, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share