Complicated AppendicitisPhase 3ALPACANCT06841003
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
A Phase 3 study testing Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin in people with Complicated Appendicitis and Intra-Abdominal Abscess, run by Spaarne Gasthuis at 11 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Complicated Appendicitis, Intra-Abdominal Abscess
- What is being tested?
- Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 11 sitesNetherlands
- Study dates
- 24 Feb 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age under 8 years;
- Not able to give informed consent (language barrier, legally incapable)
- Any contraindication for the use of the study medication:
- 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;
- Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection:
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- Sepsis-induced hypotension
- Lactate above upper limits laboratory normal
- Urine output <0.5 mL/kg/h for more than 2h despite adequate fluid resuscitation
- Acute lung injury with PaO2/FiO2 <250 in the absence of pneumonia as infection source
- Acute lung injury with PaO2/FiO2 <200 in the presence of pneumonia as infection source
- Creatinine >2.0 mg/dL (176.8 μmol/L)
- Bilirubin >2mg/dL (34.2 μmol/L)
- Platelet count < 100,000 μL
- Coagulopathy (international normalized ratio (INR) > 1.5);
- ASA IV score;
- Known malignancy;
- Renal dysfunction (i.e. eGFR ≤ 60);
- Immunocompromised patients (i.e. hematological malignancies, HIV/AIDS, bone marrow transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, chemotherapy, dialysis, solid organ transplant, and immunosuppressant use (such as corticosteroids in patients with rheumatoid arthritis));
- Pregnancy;
- Known allergies to either gentamicin or clindamycin;
- Known colonization of bacteria resistant to either gentamicin or clindamycin;
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815JD
Dr. Lopes Cardozo, 072 - 548 4444, alpaca@nwz.nl
- Recruiting
Ziekenhuisgroep Twente
Almelo, Overijssel, 7609PP
Dr. Harlaar, 088 708 7878, alpaca@zgt.nl
- Recruiting
Meander Medisch Centrum
Amersfoort, Utrecht, 3813TZ
Dr. Abis, 033 850 5050, alpaca@meandermc.nl
- Recruiting
Rode Kruis Ziekenhuis
Beverwijk, North Holland, 1942LE
Dr. van der Wielen, 0251 265 555, alpaca@rkz.nl
- Recruiting
Ijsselland Ziekenhuis
Capelle aan den IJssel, South Holland, 2906ZC
Dr. Menon, 010 258 5000, alpaca@ysl.nl
- Not yet recruiting
Zuyderland Medisch Centrum
Heerlen, Limburg, 6419PC
Dr. Boerma, 088 459 7777, alpaca@zuyderland.nl
- Recruiting
Spaarne Gasthuis
Hoofddorp, North Holland, 2134TM
Gebro, 023-2241685, alpaca@spaarnegasthuis.nl
- Recruiting
Dijklander Ziekenhuis
Hoorn, North Holland, 1624 NP
Dr. Sonneveld, 0229 257 257, alpaca@dijklander.nl
- Recruiting
Máxima MC
Veldhoven, North Brabant, 5504 DB
Dr. van den Broek, 040 888 8000, alpaca@mmc.nl
- Recruiting
Zaans Medisch Centrum
Zaandam, North Holland, 1502DV
Dr. Musters, 075 650 2911, alpaca@zmc.nl
- Recruiting
Isala
Zwolle, Overijssel, 8025AB
Dr. van Westreenen, 088 624 5000, alpaca@isala.nl
About this study
Official title: Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis (ALPACA), a Multicenter Single-blinded RCT.
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.
- Conditions
- Complicated Appendicitis, Intra-Abdominal Abscess
- Being tested
- Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin
- Medical subject headings
- Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycinDrug
Peritoneal antibiotic lavage using a solution of gentamicin/clindamycin in NaCl 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic antibiotic lavage | Experimental | Not described Receives: Drug: Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intra-abdominal abscess (IAA)
Measured: Within 30 days follow-up
Secondary outcomes (15)
The number of participants with wound infections measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms
Measured: Within 90-days follow-up
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
Measured: Within 90-days follow-up
Microorganisms Identified in Intra-operative Aspirate Cultures
Measured: Within 90-days follow-up
Operating time
Measured: From the moment of start surgery (the incision) to wound closure.
Readmission rate
Measured: Within 90-days follow-up
Reoperation rate
Measured: Within 90-days follow-up
Length of stay (including readmission)
Measured: Within 90-days follow-up
Adverse events of antibiotic peritoneal lavage
Measured: Within 90-days follow-up
Surgical complications according to the Clavien-Dindo classification
Measured: Within 90-days follow-up
Mortality
Measured: Within 90-days follow-up
Quality of life
Measured by digital questionnaire of EuroQol-5 Dimension (EQ-5D)
Measured: Within 90-days follow-up
The number of postoperative consultations will be measured by tracking any postoperative consultation that these patients have and comparing the incidence between treatment arms
Including emergency department visits, telephone consultations and outpatient consultations
Measured: Within 90-days follow-up
Cost-effectivity (in Euros) Measured Using the Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ)
Cost-effectivity will be determined by IMTA Productivity Cost Questionnaire (iPCQ)
Measured: Within 90-days follow-up
Microbial cultures of postoperative intra-abdominal asbcess, based on cultures
Measured: Within 90-days follow-up
Healthcare Costs (in Euros) Measured Using the Institute for Medical Technology Assessment Medical Consumption Questionnaire (iMCQ)
The cost-effectivity will be determined by iMTA Medical Consumption Questionnaire
Measured: Within 90-days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start24 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841003
- Sponsor's protocol ID
- 2024-514850-59-00
- Acronym
- ALPACA
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis (ALPACA), a Multicenter Single-blinded RCT.
- ClinicalTrials.gov ID
- NCT06841003
- Acronym / sponsor ID
- ALPACA / 2024-514850-59-00
- Conditions
- Complicated Appendicitis, Intra-Abdominal Abscess
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic antibiotic lavage | Experimental | Drug: Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin |
| Control group | No intervention | – |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (22 listed)
- Age under 8 years;
- Not able to give informed consent (language barrier, legally incapable)
- Any contraindication for the use of the study medication:
- Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection:
- ASA IV score;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycinPeritoneal antibiotic lavage using a solution of gentamicin/clindamycin in NaCl 0.9%. | Drug | Laparoscopic antibiotic lavage |
Primary outcome
The incidence of intra-abdominal abscess (IAA)
Time frame: Within 30 days follow-up
15 secondary outcomes
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
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
Microorganisms Identified in Intra-operative Aspirate Cultures
Time frame: Within 90-days follow-up
Operating time
Time frame: From the moment of start surgery (the incision) to wound closure.
Readmission rate
Time frame: Within 90-days follow-up
Reoperation rate
Time frame: Within 90-days follow-up
Length of stay (including readmission)
Time frame: Within 90-days follow-up
Adverse events of antibiotic peritoneal lavage
Time frame: Within 90-days follow-up
Surgical complications according to the Clavien-Dindo classification
Time frame: Within 90-days follow-up
Mortality
Time frame: Within 90-days follow-up
Quality of life
Time frame: Within 90-days follow-up
The number of postoperative consultations will be measured by tracking any postoperative consultation that these patients have and comparing the incidence between treatment arms
Time frame: Within 90-days follow-up
Cost-effectivity (in Euros) Measured Using the Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ)
Time frame: Within 90-days follow-up
Microbial cultures of postoperative intra-abdominal asbcess, based on cultures
Time frame: Within 90-days follow-up
Healthcare Costs (in Euros) Measured Using the Institute for Medical Technology Assessment Medical Consumption Questionnaire (iMCQ)
Time frame: Within 90-days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic antibiotic peritoneal lavage with gentamicin / clindamycin in people with Complicated Appendicitis and Intra-Abdominal Abscess, run by Spaarne Gasthuis at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emeline Gebro, Master of science degree (+31(0)23 2241685, alpaca@spaarnegasthuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intra-abdominal abscess (IAA) (time frame: Within 30 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.