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Clinical trial

Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study.

ID
Name
P-2021-27
Description
The PIPA trial is a prospective, multicentre, cluster randomized cluster crossover non-inferiority study. We aim to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days
Trial arms
Trial start
2021-05-01
Estimated PCD
2024-05-31
Trial end
2024-05-31
Status
Recruiting
Treatment
Antibiotic
The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.
Arms:
Arm 1- Postoperative Course, Arm 2 - Postoperative Course
Other names:
metronidazole intravenous, metronidazole oral, Piperacillin / Tazobactam, Amoxicillin / Clavulanic acid
Size
2631
Primary endpoint
Intra-abdominal abscess
Assessed at postoperative day 30
Eligibility criteria
Inclusion Criteria: * On cluster level, hospitals with emergency surgical admissions performing laparoscopic appendectomies are eligible for inclusion. * On an individual level, participants are eligible for inclusion if they undergo a laparoscopic appendectomy for appendicitis (both uncomplicated and complicated), are ≥ 18 years of age, and provide a signed written consent form. Exclusion Criteria: * Exclusion criteria are specifically related to the therapy and individual participants will be excluded if they undergo any other procedures than laparoscopic appendectomy during index surgery.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'An electronic randomization sequence in the program R will be applied to randomize centers (clusters) 1:1. After randomization the allocation will not be concealed'}}, 'enrollmentInfo': {'count': 2631, 'type': 'ESTIMATED'}}
Updated at
2024-04-10

1 organization

1 product

1 indication

Organization
Zealand University Hospital
Product
Antibiotic
Indication
Appendicitis