Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy
New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial
1 other identifier
interventional
97
1 country
1
Brief Summary
Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter through the oropharynx so chances of infectious complications are negligible. It was not popular because of associated risks and complications. However the new introducer PEG gastropexy has been recently proved to be safe. To determine the incidence of peristomal wound infections during the immediate 7 day post procedure follow up period after the new introducer PEG gastropexy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2006
CompletedFirst Posted
Study publicly available on registry
September 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 7, 2007
May 1, 2007
September 12, 2006
May 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
peristomal infection rate over a period of 7 days after PEG-gastropexy
cross sectional
Interventions
Eligibility Criteria
You may qualify if:
- Patients having very tight stenotic malignant lesions of the upper GI tract (i.e. esophagus and or oropharynx) in whom routine pull PEG is not possible without dilatation/bougeinage of the UGI tract. The GI lumen in patients included in this study would have just sufficiently enough diameters to allow only the passage of thin (8.8 mm) endoscope.
You may not qualify if:
- Allergies to Ceftriaxone antibiotics,
- Patients receiving systemic antibiotics,
- Any contraindications to PEG like, severe coagulation disorders, peritonitis, peritoneal carcinomatosis, burns or inability to achieve transillumination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital,
Frankfurt am Main, D60590, Germany
Related Publications (1)
Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study. Gastrointest Endosc. 2008 Apr;67(4):620-8. doi: 10.1016/j.gie.2007.10.044.
PMID: 18374024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yogesh M Shastri, MD, DNB
JW Goethe University Hospital, Frankfurt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2006
First Posted
September 13, 2006
Study Start
October 1, 2003
Study Completion
April 1, 2007
Last Updated
May 7, 2007
Record last verified: 2007-05