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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:
Drawbacks of the direct techniques are:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Push/pull endoscopic gastrostomy | Active Comparator |
| |
| Gastrostomy after gastropexy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with peristomal wound infection. | Peristomal wound infection is defined as Jain score > 8, or presence of purulent exudates. | From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first. |
| Number of patients with major complication. | 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. | From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first. |
| Number of failures of positioning the gastrostomy tube. | 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. | From the start until the end of the endoscopic procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Jain's score. | Jain's score is a validated scoring system, proposed to evaluate peristomal infection. | Jain score will be measured at follow up visits during the first month after positioning of the gastrostomy tube (on 7th, 15th, 30th days). |
| Number of gastrostomy tube substitutions for each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Camellini, MD | Azienda USL Reggio Emilia - IRCCS | Principal Investigator |
| Vincenzo Mirante, MD | Nuovo Ospedale Estense - AUSL Modena | Study Chair |
| Veronica Iori, MD | Azienda USL Reggio Emilia - IRCCS | Study Chair |
| Angela Mazzocchi, MD | Artificial Nutrition Interdisciplinary Team - AUSL Reggio Emilia | Study Chair |
| Fabio Fabbian, MD | Endoscopy Unit - AUSL RE | Study Chair |
| Rita Conigliaro, MD | Nuovo Ospedale Estense - AUSL Modena | Study Chair |
| Romano Sassatelli, MD | Azienda USL Reggio Emilia - IRCCS | Study Chair |
| Giorgio Iori, Reg. Nurse | Azienda USL Reggio Emilia - IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Endoscopy Unit - Nuovo Ospedale Estense | Modena | MO | 41125 | Italy | ||
| Gastroenterology and Digestive Endoscopy Unit - Arcispedale Santa Maria Nuova |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12776029 | Background | Maetani I, Tada T, Ukita T, Inoue H, Sakai Y, Yoshikawa M. PEG with introducer or pull method: a prospective randomized comparison. Gastrointest Endosc. 2003 Jun;57(7):837-41. doi: 10.1016/s0016-5107(03)70017-0. | |
| 3318609 | Background | Jain NK, Larson DE, Schroeder KW, Burton DD, Cannon KP, Thompson RL, DiMagno EP. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy. A prospective, randomized, double-blind clinical trial. Ann Intern Med. 1987 Dec;107(6):824-8. doi: 10.7326/0003-4819-107-6-824. |
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|
| 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. |
|
|
The setting of the substitution will be recorded (at bed site, endoscopic unit, other sanitary facilities). |
| 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. |
| Number of episodes of referral to the hospital or to any sanitary facility (outpatient clinic visit included), due to gastrostomy tube. | 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 |
| Days of antibiotic therapy after gastrostomy tube positioning. | From the date of randomization up to 30 days, or until the date of death from any cause, whichever came first. |
| Mean time required for tube positioning, as measured in minutes. | From the start until the end of the endoscopic procedure. |
| Reggio Emilia |
| RE |
| 42125 |
| Italy |
| Endoscopic Unit "South Area" - AUSL Reggio Emilia | Scandiano | RE | 42019 | Italy |
| 18374024 | Background | Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study. Gastrointest Endosc. 2008 Apr;67(4):620-8. doi: 10.1016/j.gie.2007.10.044. |
| 18773341 | Background | Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama M. Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy. Endoscopy. 2008 Sep;40(9):722-6. doi: 10.1055/s-2008-1077490. Epub 2008 Sep 4. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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