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Completed

NCT Number: NCT01463540

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.

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Key information

Conditions

Gastrostomy, Methods Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Digestive Endoscopy Unit - Nuovo Ospedale Estense, Modena, MO, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study.

Exclusion criteria

  • age < 18
  • age > 85 years old
  • pregnancy
  • coagulation deficit or anti-coagulant oral therapy
  • total gastrectomy
  • absence of trans-illumination, verified during esophagogastroduodenoscopy
  • pharyngeal or esophageal stenosis, not allowing the passage of a standard scope;
  • ascitis
  • active gastric ulcer
  • the patient or his tutor do not consent to the study
  • documented allergy to penicillin
  • ASA V.

Treatment and study plan

A 20 Fr gastrostomy tube, placed using push/pull techniques.

Device

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.

A 20 Fr balloon type tube, placed after gastropexy.

Device

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 names: Kimberly Clark MIC Introducer Kit Product CODE 98423.

Primary outcomes

  1. Number of patients with peristomal wound infection.

    Time frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.

    Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates.

  2. Number of patients with major complication.

    Time frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.

    Major complications include: 1. perforation/peritonitis or hemoperitoneum, requiring surgery; 2. Clinically relevant gastrointestinal bleeding (loss of more than 2g Hb during 24 hours and/or requiring transfusion and/or endoscopic or surgical treatment); 3. aspiration pneumonia; 4. Burried bumper syndrome.

  3. Number of failures of positioning the gastrostomy tube.

    Time frame: From the start until the end of the endoscopic procedure.

    Gastrostomy tube positioning will be performed immediately after randomization.Patients will be randomised by the endoscopist, during EGD. Only one attempt of positioning the gastrostomy tube will be allowed. Further attempts of positioning a gastrostomy tube after a failure will be not relevant to the pourpose of the study. Failures do not include patients with uncorrect positioning of the tube, if the misplacement is diagnosed after the end of the endoscopic procedure.

Secondary outcomes

  1. Mean Jain's score.

    Time frame: Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days).

    Jain's score is a validated scoring system, proposed to evaluate peristomal infection.

  2. Number of gastrostomy tube substitutions for each patient.

    Time frame: From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months.

    The setting of the substitution will be recorded (at bed site, endoscopic unit, other sanitary facilities).

  3. Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube.

    Time frame: From date of randomization until the date of definitive removal of the tube or date of death from any cause, whichever came first, assessed up to 13 months

  4. Days of antibiotic therapy after gastrostomy tube positioning.

    Time frame: From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first.

  5. Mean time required for tube positioning, as measured in minutes.

    Time frame: From the start until the end of the endoscopic procedure.

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Nov 2, 2011
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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