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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 . DESIGN Prospective , randomized , double-blind , placebo-controlled trial . SETTINGS Multicenter ; a university tertiary-care hospital and a private practice endoscopy clinic . PATIENTS 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 . INTERVENTIONS 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 . MAIN OUTCOME MEASUREMENTS 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 . LIMITATIONS 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 ) .
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Intervention_Pharmacological
New introducer PEG gastropexy
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Intervention_Pharmacological
prophylactic ceftriaxone
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
The new introducer PEG-gastropexy technique
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Outcome_Other
Clinically significant wound reaction
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Outcome_Other
Wound infection scores
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Outcome_Other
values of infection scores
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Participant_Sample-size
633 patients
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Participant_Sample-size
Ninety-seven
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Participant_Condition
malignant stenotic oropharyngeal stricture
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Participant_Condition
advanced oropharyngeal malignancy