Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8+
SponsorSpaarne Gasthuis

About this trial

Appendicitis is one of the most common causes of acute surgical admission. Presently, two types of appendicitis are distinguished: complicated and uncomplicated (phlegmonous). Complicated appendicitis (CA) is defined as gangrenous and/or perforated appendicitis and/or appendicitis with an intra-abdominal or pelvic abscess. Laparoscopic appendectomy has become the preferential mode of surgical treatment. However, development of an intra-abdominal abscess (IAA) remains an important and clinically relevant complication following appendectomy, especially in complicated appendicitis. Although patients with complicated appendicitis receive postoperative intravenous antibiotics, the incidence of IAA remains considerable. The reported incidence of IAA in children and adults with CA is 7.9% - 24%. We recently reported an IAA rate of 12.3% after laparoscopic appendectomy for CA in our own institution. Patients with IAA are readmitted and treated with either antibiotics, image-guided percutaneous drainage, surgical reintervention, or a combination of these treatments. Furthermore, IAA represents a considerable burden for the healthcare system with high readmission rates and reinterventions, prolonged hospital stay, and therefore increased medical costs. Intra operative techniques aiming at more effective infection source control represent a clinically relevant area of investigation. Laparoscopic antibiotic lavage represents a promising concept in order to reduce intra-abdominal abscess formation. Antibiotic lavage is mainly known for the treatment of peritoneal dialysis associated peritonitis. Several studies show promising results of antibiotic peritoneal lavage on the incidence of surgical site infections (SSIs) including IAA in patients with CA. However, these studies were retrospective or conducted in a small number of patients who underwent an open appendectomy while high quality randomized controlled trials have not been performed yet.

The aim of the ALPACA study is to evaluate the effect of laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin for 3 minutes after appendectomy on the incidence of IAA in patients with CA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of CA undergoing a laparoscopic appendectomy for intra-operative confirmed CA that can provide a signed written consent form.

Disqualifiers

Age under 8 years;

Not able to give informed consent (language barrier, legally incapable)

Hypersensitivity to clindamycin or to any of the excipients benzyl alcohol, sodium edetate, water, or to lincomycin;

Hypersensitivity to gentamicin or to sodium metabisulfite: particularly in asthmatic patients, this may trigger bronchospasms and anaphylactic shock or to any of the excipients: disodium edetate, sodium hydroxide, sodium metabisulfite (E223), water for injections;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin

    Drug

    Peritoneal antibiotic lavage using a solution of gentamicin/clindamycin in NaCl 0.9%.

Treatment groups

752 Participants
are divided into 2 treatment groups
Group A: Laparoscopic antibiotic lavageExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence of intra-abdominal abscess (IAA)

Time frame
Within 30 days follow-up

Secondary outcomes

1

The number of participants with wound infections measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms

Time frame
Within 90-days follow-up
2

Number of participants receiving each type of treatment for the intra-abdominal abscess, consisting of percutaneous (radiological drainage), surgical drainage, antibiotic treatment or observation only

Time frame
Within 90-days follow-up
3

Microorganisms Identified in Intra-operative Aspirate Cultures

Time frame
Within 90-days follow-up
4

Operating time

Time frame
From the moment of start surgery (the incision) to wound closure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaarne Gasthuis

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator