AppendicitisNCT01356641
Antibiotic Treatment Alone for Acute Simple Appendicitis in Children
A study testing Antibiotic treatment alone and Appendectomy in people with Appendicitis, run by Ramon R. Gorter at 4 sites in Netherlands.
Trial summary
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Antibiotic treatment alone and Appendectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesNetherlands
- Study dates
- Sep 2012to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-17 years
- Radiologically confirmed simple appendicitis, defined as:
- Clinical findings: i. Unwell, but not generally ill ii. Localized tenderness in the right iliac fossa region iii. Normal/hyperactive bowel sounds iv. No guarding v. No mass palpable b. Ultrasonography: i. Incompressible appendix with an outer diameter of ≥6 mm ii. Hyperaemia within the appendiceal wall iii. Without fecalith iv. Infiltration of surrounding fat v. No signs of perforation vi. No signs of intra abdominal abscess/phlegmon
Who cannot join
- Patients with severe general illness at time of presentation:
- Generalized peritonitis defined as:
- Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus
- Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference [39]. See attachment 1.
- Signs of complex appendicitis
- Children with a fecalith on ultrasonography.
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- Patients with serious associated conditions or malformations such as:
- Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
- Immunodeficiency
- Malignancy
- Homozygous sickle cell disease
- Metabolic disorders
- Patient with documented type 1 allergy to the antibiotics used
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Flevoziekenhuis
Almere Stad
Academic medical center of Amsterdam
Amsterdam
VU University medical center
Amsterdam
Red Cross Hospital
Beverwijk
About this study
Official title: Antibiotic Treatment Alone for Acute Simple Appendicitis in Children; a Prospective Cohort Study Part of the Antibiotic Versus Primary Appendectomy in Children (APAC) Trial
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:
Read the detailed description
Primary Objective:
What is the complication rate of the initial antibiotic treatment strategy (IATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Secondary Objective:
What is the complication rate of the direct appendectomy treatment strategy (DATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Study design:
Prospective multi-centre pilot cohort study.
Study population:
Children (7-17years old) with radiologically proven simple appendicitis.
Intervention:
Initial antibiotic treatment strategy (IATS): Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily will be given for 48 hours. If possible the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days. If after 72 hours, the patient does not meet the predefined criteria, an appendectomy will be performed.
Control group:
The control group will consist of patients, who do not want the antibiotic treatment. Their medical files will be monitored prospectively. In addition they will be scheduled for an extra outpatient clinic follow up (8 weeks after discharge), extra telephone contact one year after discharge and asked to fill out quality of life questionnaires.
Primary parameters/endpoints:
Safety of initial antibiotic treatment defined as:
Occurrence of major complications, such as:
- Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy
Secondary outcome parameters Major complications associated with appendectomy
- Stumpleakage
- Intra-abdominal abscess (IAA)
- Secondary bowel obstruction (SBO)
- Superficial site infection (SSI)
- Need for secondary operation
- Need for other re-intervention
- Re-admission
- Anaesthesia related complication
- Pneumonia
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Risks of participation: Need for delayed operation, recurrent appendicitis. Risks that are also present in case of non-participation: Allergic reaction to antibiotics, known appendectomy associated complications.
- Burden of participation: Extra admission day (in comparison with appendectomy), ultrasonography after 48 hours (extra procedure), outpatient follow up (two extra visits), filling out QOL questionnaires. Burden also present in case of non-participation: Intravenous access (normal procedure), daily blood samples (normal procedure). Regarding the control group, the burden will consist of an extra outpatient clinic follow up (8 weeks after discharge), extra telephone contact one year after discharge and fill out quality of life questionnaires.
- Benefit of participation: Avoidance of surgery and its related early and late morbidity, potential better quality of life.
- Conditions
- Appendicitis
- Being tested
- Antibiotic treatment alone, Appendectomy
- Keywords
- Antibiotic treatment, Non perforated appendicitis, Children
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatment aloneDrug
Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg
AppendectomyProcedure or surgery
Appendectomy either open or laparoscopic depending on the surgeon's preference
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment alone | Experimental | Intravenous administration:
Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7mg/kg once daily
Oral administration of:
Amoxicillin/clavulanic acid 50/12.5 mg/kg/day (in three doses) Receives: Drug: Antibiotic treatment alone |
| Appendectomy | Active comparator | Routine appendectomy either laparoscopic or open depending on the surgeon's preference Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of initial antibiotic treatment strategy
Occurrence of major complications, such as:
- Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy
Measured: 0-12 months
Secondary outcomes (1)
Safety of the direct appendectomy treatment strategy
Major complications associated with appendectomy
- Stumpleakage
- Intra-abdominal abscess (IAA)
- Secondary bowel obstruction (SBO)
- Superficial site infection (SSI)
- Need for secondary operation
- Need for other re-intervention
- Re-admission
- Anaesthesia related complication
- Pneumonia
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startSep 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramon R. Gorter
- Sponsor type
- University, hospital or other
- Collaborators
- Red Cross Hospital Beverwijk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), St. Antonius Hospital, Flevoziekenhuis
- Responsible party
- Sponsor-investigator, Ramon R. Gorter, VU University of Amsterdam
- Investigators
- Ramon R Gorter, MD, Principal investigator, Amsterdam UMC, location VUmcHugo A Heij, MD, PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356641
- Sponsor's protocol ID
- KCA2011/APAC
- Status last verified
- Jan 2017
- First submitted
- 18 Apr 2011
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment Alone for Acute Simple Appendicitis in Children; a Prospective Cohort Study Part of the Antibiotic Versus Primary Appendectomy in Children (APAC) Trial
- ClinicalTrials.gov ID
- NCT01356641
- Acronym / sponsor ID
- KCA2011/APAC
- Conditions
- Appendicitis
- Keywords
- Antibiotic treatment, Non perforated appendicitis, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ramon R. GorterUniversity, hospital or other
- Collaborators
- Red Cross Hospital Beverwijk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), St. Antonius Hospital, Flevoziekenhuis
- Study start
- Sep 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 May 2011 (estimated)
- 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.
Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:
Detailed description
Primary Objective:
What is the complication rate of the initial antibiotic treatment strategy (IATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Secondary Objective:
What is the complication rate of the direct appendectomy treatment strategy (DATS) for acute simple appendicitis (radiological proven) in children aged 7-17 years old?
Study design:
Prospective multi-centre pilot cohort study.
Study population:
Children (7-17years old) with radiologically proven simple appendicitis.
Intervention:
Initial antibiotic treatment strategy (IATS): Intravenous administration of amoxicillin/clavulanic acid 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) and gentamicin 7mg/kg once daily will be given for 48 hours. If possible the antibiotics will be switched to oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days. If after 72 hours, the patient does not meet the predefined criteria, an appendectomy will be performed.
Control group:
The control group will consist of patients, who do not want the antibiotic treatment. Their medical files will be monitored prospectively. In addition they will be scheduled for an extra outpatient clinic follow up (8 weeks after discharge), extra telephone contact one year after discharge and asked to fill out quality of life questionnaires.
Primary parameters/endpoints:
Safety of initial antibiotic treatment defined as:
Occurrence of major complications, such as:
- Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy
Secondary outcome parameters Major complications associated with appendectomy
- Stumpleakage
- Intra-abdominal abscess (IAA)
- Secondary bowel obstruction (SBO)
- Superficial site infection (SSI)
- Need for secondary operation
- Need for other re-intervention
- Re-admission
- Anaesthesia related complication
- Pneumonia
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Risks of participation: Need for delayed operation, recurrent appendicitis. Risks that are also present in case of non-participation: Allergic reaction to antibiotics, known appendectomy associated complications.
- Burden of participation: Extra admission day (in comparison with appendectomy), ultrasonography after 48 hours (extra procedure), outpatient follow up (two extra visits), filling out QOL questionnaires. Burden also present in case of non-participation: Intravenous access (normal procedure), daily blood samples (normal procedure). Regarding the control group, the burden will consist of an extra outpatient clinic follow up (8 weeks after discharge), extra telephone contact one year after discharge and fill out quality of life questionnaires.
- Benefit of participation: Avoidance of surgery and its related early and late morbidity, potential better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment alone | Experimental | Drug: Antibiotic treatment aloneIntravenous administration: Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7mg/kg once daily Oral administration of: Amoxicillin/clavulanic acid 50/12.5 mg/kg/day (in three doses) |
| Appendectomy | Active comparator | Procedure: AppendectomyRoutine appendectomy either laparoscopic or open depending on the surgeon's preference |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 7-17 years
- Radiologically confirmed simple appendicitis, defined as:
Key exclusion criteria (13 listed)
- Patients with severe general illness at time of presentation:
- Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus
- Children with a fecalith on ultrasonography.
- Patients with serious associated conditions or malformations such as:
- Patient with documented type 1 allergy to the antibiotics used
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 |
|---|---|---|
| Antibiotic treatment aloneAmoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg | Drug | Antibiotic treatment alone |
| AppendectomyAppendectomy either open or laparoscopic depending on the surgeon's preference | Procedure or surgery | Appendectomy |
Primary outcome
Safety of initial antibiotic treatment strategy
Time frame: 0-12 months
Occurrence of major complications, such as: A. Anaphylactic shock and other allergic reaction to antibiotics administered b. Recurrent appendicitis within 8 weeks c. Recurrent appendicitis within one year after discharge d. Development of perforated appendicitis e. Occurrence of major complaints after delayed appendectomy such as intra-abdominal abscess (IAA), stumpleakage, superficial site infection (SSI), anaesthesia related complications, secondary bowel obstruction (SBO), re-admission, need for re-intervention f. Re-admission g. Re-intervention other than delayed appendectomy
1 secondary outcome
Safety of the direct appendectomy treatment strategy
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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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. This study is not recruiting at the moment.
Ramon R Gorter, MD principal investigator
Amsterdam UMC, location VUmc
Hugo A Heij, MD, PhD study chair
Amsterdam UMC, location VUmc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic treatment alone and Appendectomy in people with Appendicitis, run by Ramon R. Gorter at 4 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of initial antibiotic treatment strategy (time frame: 0-12 months). 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 13 Jan 2017.