NCT04249570

Brief Summary

Percutaneous endoscopic gastrostomy (PEG) was created to replace surgical gastrostomy in patients who are needed long-term tube feeding. PEG has less severe complication rate or mortality rate compared with traditional surgical gastrostomy. However, there are still some mild complications which cannot be completely prevented and peristomal infection is the most common one. Povidone-iodine (PVP-I) exhibits broad range of microbicidal activity via increasing the solubility of iodine. In our study, the gastrostomy feeding tube will be coated with a layer of Betadine before PEG technique. Investigators expect gastrostomy feeding tube coated with Betadine will reduce the oropharyngeal, esophageal and gastric bacteria colonization rate, followed by reducing peristomal infection rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
5.2 years until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

6.2 years

First QC Date

November 25, 2014

Last Update Submit

January 29, 2020

Conditions

Infection

Keywords

percutaneous endoscopic gastrostomyPovidone-iodineperistomal infection

Outcome Measures

Primary Outcomes (1)

  • Peristomal infection rate

    For each patient, the peristomal area was evaluated daily for 2 weeks after PEG placement. The presence of erythema and of exudate were scored on a scale of 0 to 4; induration was scored on a scale of 0 to 3. Criteria for infection were a maximum combined score of 8 or higher, or the presence of microscopic and microbiologic evidence of suppurating exudate.

    two weeks

Secondary Outcomes (2)

  • Pneumonia

    two weeks

  • Serum CRP level changes before and after PEG placement

    3 days

Study Arms (2)

Iodine

EXPERIMENTAL

gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique

Other: Povidone iodine

No iodine

NO INTERVENTION

gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique

Interventions

Povidone iodineOTHER
Also known as: Betadine
Iodine

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with central nervous system disorder, head and neck cancer, esophageal motility disorder or swallowing dysfunction related to face trauma, who are the candidates for percutaneous endoscopic gastrostomy under doctors' suggestion
  • Patients between 20 and 100 years old

You may not qualify if:

  • History of upper abdominal surgery
  • Intra-abdominal hemorrhage
  • Massive ascites
  • Severe coagulopathy
  • Malignancy infiltration to the stomach
  • Severe left lobe hypertrophy of liver
  • High position of transverse colon
  • Esophageal stricture
  • Thyroid disease
  • Allergy to Cephalosporin or Povidine iodine
  • Current antibiotics use or use antibiotics in recent 2 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital, Taiwan

Taipei, 11217, Taiwan

Location

Related Publications (1)

  • Chen YJ, Hou MC, Yang TC, Lee PC, Wang YP, Huang YH, Lee FY. Effectiveness of betadine-coating gastrostomy tube to reduce peristomal infection after percutaneous endoscopic gastrostomy: a randomized controlled trial. BMC Gastroenterol. 2023 May 15;23(1):155. doi: 10.1186/s12876-023-02702-w.

    PMID: 37189057DERIVED

MeSH Terms

Conditions

Infections

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ming-Chih Hou, MD

    Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

  • Yen-Po Wang

    Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

January 31, 2020

Study Start

April 1, 2014

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

TW(1)