Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques
Condition: Gastrostomy, Methods
Study type: Interventional
Phase: Phase 4

Summary: 
      Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well
      standardized technique. Two variants of this maneuver - the pull and the push techniques -
      are widespread worldwide. More recently different techniques, that allow the direct insertion
      of a gastrostomy tube has been described. The common characteristic shared by all these
      technique is the fact that the gastrostomy tube is inserted directly into the stomach
      (without passing through the pharynx), after the gastric and abdominal wall have been
      securely fasten together (gastropexy).

      Advantage of direct techniques are the followings:

        1. the tube can placed also in the case of an oesophageal stenosis

        2. studies suggest that the peristomal wound infection are less frequent using direct
           techniques

        3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be
           placed also in the case of first positioning. Both the balloon type tube and the button
           are easy to be changed also at the bed-side.

      Drawbacks of the direct techniques are:

        1. these technique are easy, but a little more cumbersome than classic push or pull
           maneuvers

        2. operators are often not familiar with direct insertion

        3. kits suited for direct insertion are generally more costly than available kits for push
           or pull placement of gastrostomy tube.

      The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a
      balloon type gastrostomy tube or of a button and it is interesting, because it makes simple
      to perform the gastropexy.

      The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement
      of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore
      if a balloon type gastrostomy tube or a button are positioned, they may be changed at the
      bed-side, without referral of the patient to the endoscopic unit or to an other sanitary
      facility.
    


Intervention name(s): A 20 Fr gastrostomy tube, placed using push/pull techniques.; A 20 Fr balloon type tube, placed after gastropexy.
Intervention type(s): Device; Device
Intervention description(s): In this group a 20 Fr gastrostomy tube will be placed, of the type in use at each centre, using the push or the pull method. Positioning of the gastrostomy tube will be carried out endoscopically in sedated patients, after antibiotic prophylaxis. Single dose ampicillin/sulbactam 1g/500 mg will be infused intravenously 30 minutes before positioning. In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis with ampicillin/sulbactam will be not given.; In this group a 20 Fr balloon type gastrostomy tube will be placed endoscopically, after gastropexy performed using the Kimberly Clarke MIC Introducer kit, according to the instructions suggested by the manufacturer. The kit includes 4 T-fasteners (only 3 are usually placed in clinical use) and a serial 24 Fr dilator with a pell-away sheath. All commercially available brands of balloon type gastrostomy tubes will be allowed for use in the study. Positioning of the gastrostomy tube will be carried out in sedated patients, after antibiotic prophylaxis (Single dose ampicillin/sulbactam 1g/500 mg ev.). In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis will be not given.
Other intervention name(s): Kimberly Clark MIC Introducer Kit Product CODE 98423.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enteral nutrition; Gastrostomy, adverse effects; Gastrostomy, nursing; Endoscopy,gastrointestinal; Surgical wound infection