Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.

NCT04803422 | Completed

• 1 other identifier: P-2021-27
• Study Type: interventional
• Target: 3,193
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Complicated Appendicitis

Outcome Measures

Primary Outcomes (1)

• Intra-abdominal abscess

  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 Outcomes (4)

• postoperative stay

  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

  Assessed at postoperative day 30

• Costs

  Assessed at postoperative day 30. Data for both in- and outpatient costs will be extracted from the Danish Health Authority

• Wound infection

  Assessed postoperative day 30

Study Arms (2)

Arm 1- Postoperative Course

ACTIVE COMPARATOR

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.

Drug: Antibiotic

Arm 2 - Postoperative Course

ACTIVE COMPARATOR

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.

Drug: Antibiotic

Interventions

Antibiotic DRUG

The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.

Also known as: metronidazole intravenous, metronidazole oral, Piperacillin / Tazobactam, Amoxicillin / Clavulanic acid

Arm 1- Postoperative Course; Arm 2 - Postoperative Course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (2)

Slagelse Hospital, Department of Surgery

Slagelse, 4200, Denmark

Location

Department of Surgery, Slagelse Hospital

Slagelse, Denmark

Location

Related Publications (1)

• Mohamud AA, Zeyghami W, Kleif J, Gogenur I. Postoperative recovery in peroral versus intravenous antibiotic treatment following laparoscopic appendectomy for complicated appendicitis: a substudy of a cluster randomized cluster crossover non-inferiority study. Langenbecks Arch Surg. 2024 Oct 9;409(1):303. doi: 10.1007/s00423-024-03491-w.

  PMID: 39379540 DERIVED

MeSH Terms

Interventions

Anti-Bacterial Agents; Metronidazole; Piperacillin, Tazobactam Drug Combination; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Clavulanic Acid; Clavulanic Acids; Amoxicillin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 17, 2021
• Study Start: April 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)