Clinical trial · Interventional
Role of Prophylactic Antibiotics in New Introducer PEG-Gastropexy
New Introducer PEG-Gastropexy Does Not Need Prophylactic Antibiotics: Prospective Randomised Double Blind Placebo Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Peristomal infections are the commonest complications of PEG despite prophylactic antibiotics which may result in emergence of resistant micro-organisms like Methicillin resistant Staphylococcus aureus (MRSA). Introducer PEG technique avoids the sojourn of PEG catheter through the oropharynx so chances of infectious complications are negligible. It was not popular because of associated risks and complications. However the new introducer PEG gastropexy has been recently proved to be safe. To determine the incidence of peristomal wound infections during the immediate 7 day post procedure follow up period after the new introducer PEG gastropexy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-Gastropexy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- peristomal infection rate over a period of 7 days after PEG-gastropexy
- timeFrame
- cross sectional
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 88 Years
Show eligibility criteria text
Inclusion Criteria: * Patients having very tight stenotic malignant lesions of the upper GI tract (i.e. esophagus and or oropharynx) in whom routine pull PEG is not possible without dilatation/bougeinage of the UGI tract. The GI lumen in patients included in this study would have just sufficiently enough diameters to allow only the passage of thin (8.8 mm) endoscope. Exclusion Criteria: * Allergies to Ceftriaxone antibiotics, * Patients receiving systemic antibiotics, * Any contraindications to PEG like, severe coagulation disorders, peritonitis, peritoneal carcinomatosis, burns or inability to achieve transillumination.
References
Publications (1)
- DERIVEDShastri 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. PMID 18374024