Clinical trial NCT04803422: Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.
Official title: Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complicated Appendicitis
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 3193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Intra-abdominal abscess
timeFrame: Assessed at postoperative day 30
Secondary outcomes:
measure: postoperative stay
timeFrame: 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.
measure: Complications according to Clavien-Dindo Classifcation
timeFrame: Assessed at postoperative day 30
measure: Costs
timeFrame: Assessed at postoperative day 30. Data for both in- and outpatient costs will be extracted from the Danish Health Authority
measure: Wound infection
timeFrame: Assessed postoperative day 30
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Hospital, Department of Surgery
city: Slagelse
country: Denmark
facility: Department of Surgery, Slagelse Hospital
Study officials:
References: