Trial investigating duration of postoperative antibiotic treatment for complicated appendicitis (inflammation of the appendix)

Non-inferiority multicentre randomized controlled trial comparing short versus standard course postoperative antibiotic treatment for complex acute appendicitis - APPIC trial (Antibiotics following aPPendectomy In Complex appendicitis)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003428-21-NL

Enrollment

Unknown

Registered

2016-12-08

Start date

2017-03-14

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex appendicitis.

Interventions

Trade Name: Cefuroxime (Zinacef) Product Name: Cefuroxime (Zinacef) Product Code: RVG 20590 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: CEFUROXIME SODIUM CAS Number: 5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age minimum 8 years old (no upper limit) - patients with suspected acute appendicitis, awaiting appendectomy - written informed consent - intraoperative diagnosis of a complex appendicitis Are the trial subjects under 18? yes Number of subjects for this age range: 375 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 916 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: - appendectomy à froid - not able to give informed consent - severe sepsis, defined as sepsis-induced tissue hypoperfusion or organ dysfunction - conservative treatment of acute appendicitis - ASA score IV or not able to undergo surgery - known allergy or any other contraindication for the use of the study medication - immunocompromised patients - pregnancy - use of other antibiotics for other reason than mentioned in above. - simple acute appendicitis - intraoperative appendicular infiltration not amendable for appendectomy - inadequate source control during operation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The goal of this study is to evaluate efficacy and safety of stopping postoperative antibiotic treatment after 48 hours of intravenous therapy versus continuing for three more days (to complete a total of five days which is common practice), following appendectomy in patients suffering from complex appendicitis. ;Secondary Objective: Secondary objectives are to compare between both trial arms : - intra-abdominal abscess rate - superficial and/or deep surgical site infections rate - overall postoperative complication rate & severity - duration of postoperative antibiotic treatment - re-start of antibiotics - adverse events on antibiotics - hospital stay in hours from the operation - time to reach discharge criteria in hours from the operation - postoperative imaging for suspected complication - emergency room visits and readmission rate - cost-effectiveness All within 90 days after appendectomy.;Primary end point(s): Primary endpoint is a composite endpoint of mortality and postoperative infectious complications related to complex appendicitis, including intra-abdominal abscess and both deep and superficial surgical site infections within 90 days. A detailed definition of intra-abdominal abscess (IAA) and surgical site infection (SSI) according to the Center for Disease Control (CDC) criteria is given in chapter 8 of the studyprotocol.;Timepoint(s) of evaluation of this end point: Follow-up until 90 days after appendectomy.	—

Measure

Time frame

Main Objective: The goal of this study is to evaluate efficacy and safety of stopping postoperative antibiotic treatment after 48 hours of intravenous therapy versus continuing for three more days (to complete a total of five days which is common practice), following appendectomy in patients suffering from complex appendicitis. ;Secondary Objective: Secondary objectives are to compare between both trial arms : - intra-abdominal abscess rate - superficial and/or deep surgical site infections rate - overall postoperative complication rate & severity - duration of postoperative antibiotic treatment - re-start of antibiotics - adverse events on antibiotics - hospital stay in hours from the operation - time to reach discharge criteria in hours from the operation - postoperative imaging for suspected complication - emergency room visits and readmission rate - cost-effectiveness All within 90 days after appendectomy.;Primary end point(s): Primary endpoint is a composite endpoint of mortality and postoperative infectious complications related to complex appendicitis, including intra-abdominal abscess and both deep and superficial surgical site infections within 90 days. A detailed definition of intra-abdominal abscess (IAA) and surgical site infection (SSI) according to the Center for Disease Control (CDC) criteria is given in chapter 8 of the studyprotocol.;Timepoint(s) of evaluation of this end point: Follow-up until 90 days after appendectomy.

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Secondary

Measure	Time frame
Secondary end point(s): Secundary outcomes are amongst others: intra-abdominal abscess, superficial and/or deep surgical site infections, restart of antibiotics, hospital stay in hours, readmission rate and cost-effectiveness. Study variables are: age at time of diagnosis, location of operation, medical history (including diabetes mellitus, corticosteroid use), ASA score, gender, BMI, body temperature and laboratory results at time of presentation (CRP, WBC, eGFR), diagnostic radiological imaging, duration and severity of abdominal pain (VAS scale), antibiotic use prior to clinical diagnosis of acute appendicitis (type and dosage), prophylactic antibiotic use (type and dosage), laparoscopic or open appendectomy, duration of operation (skin-to-skin time), type of appendicitis (phlegmonous, gangrenous or perforated, with or without abscess), degree of peritonitis, level of expertise of surgeon, peritoneal irrigation and/or suction, wound management, use of (endo)loops or (endo)stapler, intraperitoneal drain placement, cultures of intra-abdominal fluid collections, histological type of appendicitis, (time to reach) discharge criteria, postoperative imaging for suspected complications, intra-abdominal abscess (IAA), deep and/or superficial surgical site infection (SSI), treatment of IAAs and SSIs, any other postoperative complication including severity, duration and doses of antibiotics received, restart of antibiotics and type, adverse events on antibiotics, type and resistance profile of cultured micro-organisms postoperatively, length of hospital stay, post-operative outpatient visit, readmission, re-interventions for complications (all within 90 days after appendectomy). ;Timepoint(s) of evaluation of this end point: Also follow-up until 90 days after appendectomy.	—

Measure

Time frame

Secondary end point(s): Secundary outcomes are amongst others: intra-abdominal abscess, superficial and/or deep surgical site infections, restart of antibiotics, hospital stay in hours, readmission rate and cost-effectiveness. Study variables are: age at time of diagnosis, location of operation, medical history (including diabetes mellitus, corticosteroid use), ASA score, gender, BMI, body temperature and laboratory results at time of presentation (CRP, WBC, eGFR), diagnostic radiological imaging, duration and severity of abdominal pain (VAS scale), antibiotic use prior to clinical diagnosis of acute appendicitis (type and dosage), prophylactic antibiotic use (type and dosage), laparoscopic or open appendectomy, duration of operation (skin-to-skin time), type of appendicitis (phlegmonous, gangrenous or perforated, with or without abscess), degree of peritonitis, level of expertise of surgeon, peritoneal irrigation and/or suction, wound management, use of (endo)loops or (endo)stapler, intraperitoneal drain placement, cultures of intra-abdominal fluid collections, histological type of appendicitis, (time to reach) discharge criteria, postoperative imaging for suspected complications, intra-abdominal abscess (IAA), deep and/or superficial surgical site infection (SSI), treatment of IAAs and SSIs, any other postoperative complication including severity, duration and doses of antibiotics received, restart of antibiotics and type, adverse events on antibiotics, type and resistance profile of cultured micro-organisms postoperatively, length of hospital stay, post-operative outpatient visit, readmission, re-interventions for complications (all within 90 days after appendectomy). ;Timepoint(s) of evaluation of this end point: Also follow-up until 90 days after appendectomy.

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Countries

Netherlands

Contacts

Public ContactDrs. E.M.L. de Wijkerslooth

Erasmus Medical Centre

e.dewijkerslooth@erasmusmc.nl0031107034519

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026