- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375414
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:PEG can be performed by pull, push or introducer technique, pull method is the one most commonly used worldwide. PEG site infection is clearly the commonest procedure related complication of PEG placement and the routinely used pull technique has been shown to have quite high (4-30%), peristomal infectious complications. To curtail these infectious complications various gastroenterological societies have recommended giving intravenous prophylactic antibiotics 30 minutes prior to the procedure which has been shown to significantly reduce this complication. Despite this the incidence of peristomal infectious complications remains high post PEG. Another problem associated with the administration of prophylactic antibiotics is the emergence of resistant micro-organisms especially the Methicillin resistant Staphylococcus aureus (MRSA) at the PEG site. Introducer PEG is the technique of PEG placement which avoids the transit of PEG catheter through the oropharynx. Despite its introduction since 19 years back it has not become popular among endoscopists because of technical difficulties and complications associated with it. However the newer introducer PEG technique using endoscopic gastropexy has been shown to be quite safe and easy to perform in recent studies. We at our institute have been performing this procedure since January 2003 and on prospective follow up have found much lower incidence of peristomal infections with it. Recently Maetani et al have already demonstrated in a prospective randomised trial that the introducer type PEG results in fewer infectious complications as compared to conventional pull PEG. There is no study comparing introducer PEG technique with or without administration of prophylactic antibiotics. As in principal, the chances of infections are much lower in the introducer technique. We want to address this issue in a randomised double blind placebo controlled settings in those patients who will as it is unfit to undergo routine pull PEG because of upper gastrointestinal (UGI) malignant stenoses.
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 travel of PEG catheter through the oropharynx which is richly inhabitated with microorganisms so chances of infectious complications at the raw PEG wound are negligible. This technique was not popular because of associated risks and complications in the past which has shown it to result in complications like deflation of balloons, catheter dislodgement, leading to peritonitis etc. However the new introducer PEG gastropexy has been recently proved to be safe. At our institute about 200 PEG procedures are performed annually, out of these 10-12% have tight stenotic stricture in which pull PEG is not possible without dilatation of oropharyngeal tract. We plan to randomise these patients in to 2 groups with and without antibiotics (placebo). PEG will be done using the new introducer PEG, Freka® Pexact CH/FR 15 (Fresenius Kabi, Germany), in which the gastric wall is sutured non surgically to the anterior abdominal wall using 2 silk sutures. Peristomal wound would be assessed daily for 7 days using 2 types of point scores systems (given by Jain and by Gossner) by 2 members of nutrition support team independently. As these are the objective scoring systems, we intend to determine the grades of post procedure peristomal infections in these patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Frankfurt am Main, Germany, D60590
- Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
peristomal infection rate over a period of 7 days after PEG-gastropexy
Time Frame: cross sectional
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cross sectional
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gastropexy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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