Gastrostomy, Methods Clinical Trial
Official title:
A Multicentric, Randomised Clinical Trial Comparing Short and Long Time Outcome of Gastrostomy Tube Placed After Gastropexy, Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment