Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy
Condition: Head and Neck Neoplasms; Wound Infection
MeSH terms: Wound Infection; Head and Neck Neoplasms
Study type: Interventional

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: 
      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.
    

Intervention name(s): PEG-Gastropexy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Enteral tube feeding,; endoscopic gastropexy,; percutaneous endoscopic gastrostomy,; PEG