NCT01463540

Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrostomy, Methods

Interventions

Type	Name	Description
DEVICE	A 20 Fr gastrostomy tube, placed using push/pull techniques.	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.
DEVICE	A 20 Fr balloon type tube, placed after gastropexy.	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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2014-05-01
• First posted: 2011-11-02
• Last updated: 2025-06-25

Locations

3 sites across 1 country: Italy