- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803422
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis. (PIPA)
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study.
Study Overview
Detailed Description
Complicated appendicitis increases the risk of postoperative intra-abdominal abscess. Treatment of complicated appendicitis are usually with a postoperative course of intravenous antibiotics. There is need for a study confirming the results of retrospective studies showing that a postoperative course of oral antibiotics is not inferior to intravenous antibiotics after laparoscopic surgery for complicated appendicitis.
The PIPA trial will be a prospective, multicenter, cluster randomized cluster crossover non-inferiority study designed 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. Participating hospitals will be randomized to either a 6-month period with a per oral antibiotic regime followed by a 6-month period with an intravenous antibiotic regime, or 6-month period with an intravenous antibiotic regime followed by a 6-month period with a per oral antibiotic regime for the postoperative treatment after laparoscopic surgery for complicated appendicitis. Primary outcome will be the incidence of intra-abdominal abscess by the postoperative day 30.
The study duration has been extended by three months in both arms, totaling six months, due to insufficient patient recruitment. By addressing this challenge, the research team seeks to achieve a more representative sample size to ensure robust and reliable research outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Abdirahman Mohamud, MD
- Phone Number: +45 23485194
- Email: ahmm@regionsjaelland.dk
Study Contact Backup
- Name: Jakob Kleif, MD, PhD
- Email: jakobkleif@icloud.com
Study Locations
-
-
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Slagelse, Denmark, 4200
- Recruiting
- Slagelse Hospital, Department of Surgery
-
Contact:
- Phone Number: 23485194
-
Slagelse, Denmark
- Recruiting
- Department of Surgery, Slagelse Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1- Postoperative Course
Pre-or intraoperative antibiotics (both uncomplicated and complicated) appendicits: Single-dose inj. Metronidazole and Pipperacillin/Tazobactam. In case of allergy to penicillin: Single-dose inj. Metronidazole and intravenous inj. Cefuroxim. First 6 month: Tablet Amoxicillin/Clavulanic Acid and Tablet Metronidazole.In case of allergy to Penicillin: Tablet Metronidazole and Tablet Ciprofloxacillin. Last 6 month: Intravenous Metronidazole and Intravenous Pipperacillin / Tazobactam. In case of allergy to penicillin: Intravenous Metronidazole and Intravenous Cefuroxim. |
The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.
Other Names:
|
Active Comparator: Arm 2 - Postoperative Course
Pre-or intraoperative antibiotics (both uncomplicated and complicated) appendicits: Single-dose inj. Metronidazole and Pipperacillin/Tazobactam. In case of allergy to penicillin: Single-dose inj. Metronidazole and intravenous inj. Cefuroxim. First 6 month: Intravenous Metronidazole and Intravenous Pipperacillin / Tazobactam. In case of allergy to penicillin: Intravenous Metronidazole and Intravenous Cefuroxim. Last 6 month: Tablet Amoxicillin/Clavulanic Acid and Tablet Metronidazole.In case of allergy to Penicillin: Tablet Metronidazole and Tablet Ciprofloxacillin. |
The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-abdominal abscess
Time Frame: Assessed at postoperative day 30
|
Primary outcome is defined as an imaging verified intraabdominal mass treated with drainage or antibiotics, or a surgically verified intra-abdominal abscess
|
Assessed at postoperative day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative stay
Time Frame: The event is assessed at postoperative day 30. The event is determnied beginning from the time the surgery ends till the time the patient is discharged from the hospital.
|
postoperative length of stay measured in hours
|
The event is assessed at postoperative day 30. The event is determnied beginning from the time the surgery ends till the time the patient is discharged from the hospital.
|
Complications according to Clavien-Dindo Classifcation
Time Frame: Assessed at postoperative day 30
|
complications according to the Clavien-Dindo classification at postoperative day 30, that require in- or outpatient treatment, complications grade ≥3a according to Clavien-Dindo Classification at postoperative day 30
|
Assessed at postoperative day 30
|
Costs
Time Frame: Assessed at postoperative day 30. Data for both in- and outpatient costs will be extracted from the Danish Health Authority
|
In- and outpatient costs and overall costs of both in-and- outpatient
|
Assessed at postoperative day 30. Data for both in- and outpatient costs will be extracted from the Danish Health Authority
|
Wound infection
Time Frame: Assessed postoperative day 30
|
Postoperative wound infection that require in-and - outpatient treatment.
A wound infection is defined as a clinically suspected wound infection which has been treated with an opening of the wound or where antibiotics has been administered for this indication
|
Assessed postoperative day 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Cecal Diseases
- Intraabdominal Infections
- Appendicitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- beta-Lactamase Inhibitors
- Metronidazole
- Anti-Bacterial Agents
- Amoxicillin
- Clavulanic Acid
- Clavulanic Acids
- Piperacillin
- Tazobactam
- Piperacillin, Tazobactam Drug Combination
Other Study ID Numbers
- P-2021-27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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