Laparoscopic Antibiotic Lavage to Prevent intra-abdominal Abscess formation in Complicated Appendicitis (ALPACA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC, Spaarne Gasthuis Stichting

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Feb 2025 → ongoing

Decision date (initial)

2025-01-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

ZonMw - Goed Gebruik Geneesmiddelen - Grote Trials Ronde 6 · Spaarne Gasthuis Science Fund

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

The aim of the study is to evaluate the effect of laparoscopic antibiotic peritoneal lavage with gentamicin and clindamycin for 3 minutes after appendectomy on the incidence of intra-abdominal abscess (IAA) in patients with complicated appendicitis (CA). Our hypothesis is that laparoscopic antibiotic peritoneal lavage will result in a decrease of at least 50% in the incidence of IAA.

Secondary objectives 13

1. Wound infections
2. Treatment of IAA
3. Microbial cultures of intra-operative aspirate and of postoperative IAA
4. Operating time (time from incision to wound closure)
5. Readmission rate
6. Reoperation rate
7. Hospital length-of-stay (including readmission)
8. Surgical complications according to the Clavien-Dindo classification
9. Mortality
10. Adverse events of antibiotic peritoneal lavage
11. Quality of life
12. Postoperative consultations
13. Cost-effectivity

Conditions and MedDRA coding

Appendicitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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

Exclusion criteria 15

1. Age under 8 years
2. Uncomplicated appendicitis
3. A larger resection (e.g. ileocaecal resection)
4. Conversion to open appendectomy
5. Any contraindication for the use of the study medication
6. Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection: • 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);
7. ASA IV score
8. Current malignancy treated with a form of immunomodulation
9. Renal insufficiency (i.e., eGFR < 60) in adults (≥18 years of age)
10. Immunocompromised patients (i.e. haematological 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))
11. Pregnancy
12. Known allergies to either gentamicin or clindamycin
13. Known colonization of bacteria resistant to either gentamicin or clindamycin
14. Not able to give informed consent (language barrier, legally incapable)
15. Appendix not removed

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of postoperative intra-abdominal abscess within 30 days follow-up

Secondary endpoints 13

1. Wound infections (90 days)
2. Treatment of IAA (90 days)
3. Microbial cultures of intra-operative aspirate and of postoperative IAA (90 days)
4. Operating time (time from incision to wound closure - 90 days)
5. Readmission rate (90 days)
6. Reoperation rate (90 days)
7. Hospital length-of-stay (including readmission - 90 days)
8. Surgical complications according to the Clavien-Dindo classification (90 days)
9. Mortality (90 days)
10. Adverse events of antibiotic peritoneal lavage (90 days)
11. Quality of life (90 days)
12. Postoperative consultations (90 days)
13. Cost-effectivity (90 days)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Jaap Bonjer

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Jaap Bonjer

Spaarne Gasthuis Stichting

Sponsor organisation

Spaarne Gasthuis Stichting

Address

Spaarnepoort 1

City

Hoofddorp

Postcode

2134 TM

Country

Netherlands

Scientific contact point

Organisation

Spaarne Gasthuis Stichting

Contact name

Steven Oosterling (PI)

Public contact point

Organisation

Spaarne Gasthuis Stichting

Contact name

Steven Oosterling (PI)

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications