New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study.
BACKGROUND
Peristomal infections are the most common complications of PEG, despite prophylactic antibiotics. The "introducer" PEG-placement technique avoids the sojourn of a PEG catheter through the oropharynx, and hence minimizes the chances of infectious complications. Despite the obvious potential advantage, this technique failed to gain popularity, mainly as a result of other associated risks and complications. Recently, a modified introducer endoscopic PEG-gastropexy technique was shown to be quite safe. The present study is the first study that evaluated the need of prophylactic antibiotics for "introducer" PEG.


OBJECTIVE
To determine the incidence of peristomal wound infections during the immediate 7-day postprocedure follow-up.


METHODS
Prospective, randomized, double-blind, placebo-controlled trial.


METHODS
Multicenter; a university tertiary-care hospital and a private practice endoscopy clinic.


METHODS
A total of 633 patients undergoing PEG were assessed for inclusion. Ninety-seven patients who had malignant stenotic oropharyngeal stricture were randomized: group I (49 patients) received prophylactic ceftriaxone, and group II (48 patients) received a placebo. Both groups were similar in patient characteristics.


METHODS
Introducer PEG was performed by using the Freka Pexact-15 CH/FR, with the gastric wall nonsurgically sutured to the anterior abdominal wall by use of an endoscope.


METHODS
The peristomal area was assessed daily for 7 days by using 2 different types of infection scores.


RESULTS
Clinically significant wound reaction was observed in 1 patient in each group. Wound infection scores were marginally higher in the placebo group, but the differences in the values of infection scores between both the groups were not statistically significant during the 7-day post-PEG follow-up.


CONCLUSIONS
The introducer gastropexy kit is 5 times more expensive than the "pull" PEG.


CONCLUSIONS
The new introducer PEG-gastropexy technique can be performed safely, without prophylactic antibiotics in patients potentially at high risk of peristomal infectious complications (those with advanced oropharyngeal malignancy) (ClinicalTrials.gov identifier NCT00375414).
Shastri
Yogesh M
YM
Division of Gastroenterology and Clinical Nutrition, Department of Medicine I-ZAFES, Johann Wolfgang Goethe-University Hospital, Bethanien, Frankfurt am Main, Germany.
Hoepffner
Nicolas
N
Tessmer
Angelika
A
Ackermann
Hans
H
Schroeder
Oliver
O
Stein
Jürgen
J
D000368:Aged; D019072:Antibiotic Prophylaxis; D000075202:Contraindications; D004311:Double-Blind Method; D004750:Enteral Nutrition / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D004940:Esophageal Stenosis / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D020699:Gastroscopes; D005774:Gastrostomy / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000517:prevention & control; D016896:Treatment Outcome