Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375414
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2006-09-12
Brief Title:
Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics Prospective Randomised Double Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
BACKGROUNDPEG 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 CHFR 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
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 CHFR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None