AppendicitisCAPPNCT04755179
Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
An observational study of Appendicitis and Appendix Mass, run by Ramon Gorter at 32 sites in Netherlands.
Trial summary
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in children (<18 years old). Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Appendicitis, Appendix Mass, Appendicitis Perforated
- What is being tested?
- Laparoscopic appendectomy, Open appendectomy and Non-operative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,308 participants
- Where
- 32 sitesNetherlands
- Study dates
- 12 Aug 2019to 3 Jul 2024
- Phase
- Observational
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children that present with a preoperative suspicion of complex appendicitis. This suspicion is based on 4 points or more on the abovementioned complex appendicitis scoring system OR a high index of suspicion of complex appendicitis by the treating physician.
Who may be able to join
- Eligible for inclusion are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria:
- 4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are:
- Diffuse abdominal guarding (3 points)
- CRP level more than 38 mg/L (2 points)
- Signs on ultrasound / imaging indicative for complex appendicitis (2 points)
- More than one day abdominal pain (2 points)
Show all 9Show fewer
- Temperature more than 37.5 degrees Celsius (1 point)
- Or
- High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based.
Who cannot join
- Adult patients (=18 years old)
- Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Netherlands32 sites
Northwest hospital group
Alkmaar
Flevoziekenhuis
Almere Stad
Meander MC
Amersfoort
Hospital Amstelland
Amstelveen
Amsterdam UMC - Location AMC
Amsterdam
Amsterdam UMC - Location VUmc
Amsterdam
OLVG
Amsterdam
Gelre hospital
Apeldoorn
Rijnstate
Arnhem
Bravis Hospital
Bergen op Zoom
Red Cross Hospital
Beverwijk
Tergooi
Blaricum
Amphia
Breda
IJsselland Hospital
Capelle aan den IJssel
Albert Schweitzer Hospital
Dordrecht
Catharina hospital
Eindhoven
Admiraal de Ruyter Hospital
Goes
UMCG
Groningen
Spaarne Gasthuis
Haarlem
Zuyderland MC
Heerlen
Dijklander
Hoorn
Sint Antonius Hospital
Nieuwegein
Radboud UMC
Nijmegen
Laurentius
Roermond
Erasmus MC
Rotterdam
Franciscus Gasthuis & Vlietland
Rotterdam
Ikazia
Rotterdam
Maasstad Hospital
Rotterdam
Haga/JKZ
The Hague
Maxima Medical Centre
Veldhoven
Zaans Medical Centre
Zaandam
Isala
Zwolle
About this study
Official title: The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in children (<18 years old).
Main research questions: What is the difference in overall complications at three months between:
Subgroup 1 (complex appendicitis without abscess/mass formation): Laparoscopic (LA) and open appendectomy (OA) Subgroup 2: (complex appendicitis with abscess/mass formation): Non-operative treatment (NOT) and direct appendectomy
Read the detailed description
Up till now initiated research projects worldwide mainly focus on simple appendicitis (questioning the necessity of an appendectomy). However, complex appendicitis is associated with significant morbidity (up to 30%), prolonged hospital stay and high costs. Identification of the optimal treatment strategy for children with complex appendicitis is therefore essential. Heterogeneity in the treatment of complex appendicitis still exists in daily practice and reflects the lack of high-quality data and emphasizes the need for well-designed studies. Complex appendicitis can be divided into two subtypes:
- Complex appendicitis without mass/abscess. (subgroup 1) Although (inter)national guidelines agree that appendectomy should be usual care, the optimal approach (open or laparoscopy) is unclear. Laparoscopic appendectomy (LA) is increasingly applied both in adults (80%) and children (60%). Benefits reported for LA in children are, but not limited to, less superficial site infection (SSI), reduced length of hospital stay and significant less postoperative bowel obstruction compared with open appendectomy (OA). Reluctance for usage of LA in this specific subgroup, however, remains due to the potential higher incidence of post-appendectomy abscess formation (PAA) reported. However, the quality of studies on this topic is low and there is considerable inconsistency in results.
- Complex appendicitis with mass/abscess. (subgroup 2) The recommendation made in our national guideline (to perform direct appendectomy in this subgroup) is not in line with the available literature. A recent Cochrane review on this topic could only include two trials and stated that no firm conclusions could be drawn. An older systematic review, including 7 studies in children, concluded that non-operative treatment (NOT) led to fewer complications, specifically SSI and PAA, when compared to direct appendectomy. Still the recommendation from our national guideline is to perform a direct appendectomy based upon good experiences in the pediatric academic centers.
In order to investigate the optimal treatment for children with complex appendicitis we will perform a nationwide, multi-center, comparative, prospective cohort study. For the purpose of this study, treatment strategies will be standardized among the participating hospitals in order to reduce heterogeneity. Prospectively derived, high quality data will be sufficient to answer the research questions regarding the optimal treatment strategy for each subtype of complex appendicitis in the pediatric population. As it is a non-randomized prospective cohort study, propensity score matching technique will be performed in order to estimate the effect of the treatments adjusted for potential confounders.
- Conditions
- Appendicitis, Appendix Mass, Appendicitis Perforated
- Being tested
- Laparoscopic appendectomy, Open appendectomy, Non-operative treatment, Direct appendectomy
- Keywords
- Complex appendicitis, Children, Treatment
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
Laparoscopic appendectomy is performed according to daily practice but with the following standardized key points:
- Conventional laparoscopy (three-trocar technique)
- In case of purulent fluid: Suction and no peritoneal lavage procedure
- Skelletizing of the mesoappendix (coagulation/clips according to routine practice locally)
- Appendiceal stump closure: with two endoloops and dissected between the endoloops. In case of involvement of the appendiceal base, the use of endostapler is recommended.
- Withdrawal of appendix: principle of abdominal wall protection is followed (trocar technique / endobag)
- No drain placement, no nasogastric tube, and no urinary catheter routinely, only on indication.
- Closure of wounds as appropriate
Open appendectomyProcedure or surgery
Open appendectomy will be performed according to the following standardized key points:
- Gridiron incision at the right lower quadrant. (McBurney's point)
- After obtaining access to the abdominal cavity the principle of abdominal wall protection will be followed.
- The appendiceal stump will be closed by ligation, not a purse string suture.
- Closure of wounds as appropriate
Non-operative treatmentProcedure or surgery
Non-operative treatment consisting of administration of intravenous antibiotics with or without drainage procedures (in case of an abscess), reserving an appendectomy for those not responding or with recurrent disease.
One of the two antibiotic regiments:
- Combination A:
- Amoxicillin/clavulanic acid 25/2.5mg/kg 6 hourly (total 100/10 mg/kg daily. Maximum 6000/600mg a day) for children <40 kg OR Amoxicillin/clavulanic acid 1000/200mg/kg 8 hourly (total 3000/6000 mg/kg daily) for children > 40 kg
- Gentamicin 7mg/kg once daily
- Combination B:
- Cefuroxim 25 mg/kg 6 hourly (total 100 mg/kg/day. Maximum 6gram/day)
- Metronidazole 10mg/kg 8hourly (total 30 mg/kg/day. Maximum 4000 mg/day) In case of peri-appendicular abscess the decision can be made to perform a drainage procedure either percutaneously or surgical.
Direct appendectomyProcedure or surgery
laparoscopic or open appendectomy as described
| Study group | Role | What they receive |
|---|---|---|
| Complex appendicitis without abscess or mass formation | All children (<18 years old) that present with a suspicion of complex appendicitis without clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. Receives: Procedure: Laparoscopic appendectomy; Procedure: Open appendectomy | |
| Complex appendicitis with abscess or mass formation | All children (<18 years old) that present with a suspicion of complex appendicitis with clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. Receives: Procedure: Non-operative treatment; Procedure: Direct appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complications
The proportion of patients experiencing any complication within 3 months after inclusion
Measured: 3 months
Secondary outcomes (19)
Postappendectomy abscess
Proportion patients with a postappendectomy abscess
Measured: 3 months
Superficial Site Infection
Proportion of patients with a superficial site infection
Measured: 3 months
Secondary bowel obstruction
Proportion of patients with a secondary/prolonged bowel obstruction
Measured: 3 months
Days absent from school, social or sports events
Number of days absent from school, social or sports events
Measured: 30 days, 3 months
Number of days absent from work
Number of days that parents are absent from work
Measured: 30 days, 3 months
Total number of extra visits
Total number of extra visits to the outpatient clinic, general pratctitioner's office or emergency department
Measured: 30 days, 3 months
Length of hospital stay
Total length of hospital stay during follow-up due to trategy related treatment or complications
Measured: 3 months
Level of pain
Level of pain measured according to the Visual Analogue Scale (0-10 points, higher scores indicating worse outcomes)
Measured: at inclusion/baseline (=day 0), 3 days, 5 days, 30 days, 3 months
Pain medication utilization
Pain medication utilization during admission
Measured: 30 days, 3 months
Need for appendectomy
Proportion of patients not having to undergo appendectomy within 3 months after start of non-operative treatment
Measured: 3 months
Recurrent appendicitis
Proportion of patients experiencing recurrent appendicitis within 3 months after inclusion
Measured: 3 months
Early failure of non-operative treatment
Proportion of patients experiencing early failure of initial non-operative treatment
Measured: 3 months
Quality of Life questionnaire (EQ-5d-Youth/EQ-5d-Proxy)
QoL measured by the validated EQ-5d-Youth / EQ-5d-Proxy questionnaire (0-1 point, higher scores indicating better outcome)
Measured: at inclusion/baseline (=day 0), 30 days, 3 months
Quality of Life questionnaire (PedsQL 4.0)
QoL measured by the validated Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) (0-100 points, higher scores indicating better outcome) Labor Questionnaire (HLQ), Medical Consumption Questionnaire (iMCQ) and Productivity Consumption Questionnaire (iPCQ) and gathered actual health care cost
Measured: at inclusion/baseline (=day 0), 30 days, 3 months
Medical costs (iMCQ)
Medical costs measured by the iMedical Consumption Questionnaire
Measured: at inclusion/baseline (=day 0), 30 days, 3 months
Non-medical / indirect costs (iPCQ)
Non-medical / indirect costs measured by the iProductivity Cost Questionnaire
Measured: at inclusion/baseline (=day 0), 30 days, 3 months
Quality adjusted life months (QALM's)
Quality adjusted life months calculated using outcomes 14 -17
Measured: 3 months
Patient satisfaction questionnaire (PSQ-18)
Patient satisfaction measured by the Patient Satisfaction Questionnaire (PSQ) (0-100, higher scores indicating better outcome)
Measured: 3 months
Patient satisfaction questionnaire (Net promotor score)
Patient satisfaction measured by the NET PROMOTOR SCORE (0-10, higher scores indicating better outcome)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start12 Aug 2019
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramon Gorter
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor-investigator, Ramon Gorter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Ramon Gorter, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755179
- Sponsor's protocol ID
- W18_302#18.348
- Acronym
- CAPP
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Amstel P, Bakx R, van der Lee JH, van der Weide MC, Eekelen RV, Derikx JPM, van Heurn ELW, Gorter RR; CAPP collaborative study group. Identification of the optimal treatment strategy for complex appendicitis in the paediatric population: a protocol for a multicentre prospective cohort study (CAPP study). BMJ Open. 2022 Feb 17;12(2):e054826. doi: 10.1136/bmjopen-2021-054826.
PubMed 35177453
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
- ClinicalTrials.gov ID
- NCT04755179
- Acronym / sponsor ID
- CAPP / W18_302#18.348
- Conditions
- Appendicitis, Appendix Mass, Appendicitis Perforated
- Keywords
- Complex appendicitis, Children, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,308 participants (actual)
- Lead sponsor
- Ramon GorterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC, location VUmc
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 16 Feb 2021 (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.
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in children (<18 years old).
Main research questions: What is the difference in overall complications at three months between:
Subgroup 1 (complex appendicitis without abscess/mass formation): Laparoscopic (LA) and open appendectomy (OA) Subgroup 2: (complex appendicitis with abscess/mass formation): Non-operative treatment (NOT) and direct appendectomy
Detailed description
Up till now initiated research projects worldwide mainly focus on simple appendicitis (questioning the necessity of an appendectomy). However, complex appendicitis is associated with significant morbidity (up to 30%), prolonged hospital stay and high costs. Identification of the optimal treatment strategy for children with complex appendicitis is therefore essential. Heterogeneity in the treatment of complex appendicitis still exists in daily practice and reflects the lack of high-quality data and emphasizes the need for well-designed studies. Complex appendicitis can be divided into two subtypes:
- Complex appendicitis without mass/abscess. (subgroup 1) Although (inter)national guidelines agree that appendectomy should be usual care, the optimal approach (open or laparoscopy) is unclear. Laparoscopic appendectomy (LA) is increasingly applied both in adults (80%) and children (60%). Benefits reported for LA in children are, but not limited to, less superficial site infection (SSI), reduced length of hospital stay and significant less postoperative bowel obstruction compared with open appendectomy (OA). Reluctance for usage of LA in this specific subgroup, however, remains due to the potential higher incidence of post-appendectomy abscess formation (PAA) reported. However, the quality of studies on this topic is low and there is considerable inconsistency in results.
- Complex appendicitis with mass/abscess. (subgroup 2) The recommendation made in our national guideline (to perform direct appendectomy in this subgroup) is not in line with the available literature. A recent Cochrane review on this topic could only include two trials and stated that no firm conclusions could be drawn. An older systematic review, including 7 studies in children, concluded that non-operative treatment (NOT) led to fewer complications, specifically SSI and PAA, when compared to direct appendectomy. Still the recommendation from our national guideline is to perform a direct appendectomy based upon good experiences in the pediatric academic centers.
In order to investigate the optimal treatment for children with complex appendicitis we will perform a nationwide, multi-center, comparative, prospective cohort study. For the purpose of this study, treatment strategies will be standardized among the participating hospitals in order to reduce heterogeneity. Prospectively derived, high quality data will be sufficient to answer the research questions regarding the optimal treatment strategy for each subtype of complex appendicitis in the pediatric population. As it is a non-randomized prospective cohort study, propensity score matching technique will be performed in order to estimate the effect of the treatments adjusted for potential confounders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex appendicitis without abscess or mass formation | – | Procedure: Laparoscopic appendectomy, Procedure: Open appendectomyAll children (<18 years old) that present with a suspicion of complex appendicitis without clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. |
| Complex appendicitis with abscess or mass formation | – | Procedure: Non-operative treatment, Procedure: Direct appendectomyAll children (<18 years old) that present with a suspicion of complex appendicitis with clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children that present with a preoperative suspicion of complex appendicitis. This suspicion is based on 4 points or more on the abovementioned complex appendicitis scoring system OR a high index of suspicion of complex appendicitis by the treating physician.
Key inclusion criteria (9 listed)
- Eligible for inclusion are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria:
- 4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are:
- Diffuse abdominal guarding (3 points)
- CRP level more than 38 mg/L (2 points)
- Signs on ultrasound / imaging indicative for complex appendicitis (2 points)
Key exclusion criteria (2 listed)
- Adult patients (=18 years old)
- Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
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 appendectomyLaparoscopic appendectomy is performed according to daily practice but with the following standardized key points: 1. Conventional laparoscopy (three-trocar technique) 2. In case of purulent fluid: Suction and no peritoneal lavage procedure 3. Skelletizing of the mesoappendix (coagulation/clips according to routine practice locally) 4. Appendiceal stump closure: with two endoloops and dissected between the endoloops. In case of involvement of the appendiceal base, the use of endostapler is recommended. 5. Withdrawal of appendix: principle of abdominal wall protection is followed (trocar technique / endobag) 6. No drain placement, no nasogastric tube, and no urinary catheter routinely, only on indication. 7. Closure of wounds as appropriate | Procedure or surgery | Complex appendicitis without abscess or mass formation |
| Open appendectomyOpen appendectomy will be performed according to the following standardized key points: 1. Gridiron incision at the right lower quadrant. (McBurney's point) 2. After obtaining access to the abdominal cavity the principle of abdominal wall protection will be followed. 3. The appendiceal stump will be closed by ligation, not a purse string suture. 4. Closure of wounds as appropriate | Procedure or surgery | Complex appendicitis without abscess or mass formation |
| Non-operative treatmentNon-operative treatment consisting of administration of intravenous antibiotics with or without drainage procedures (in case of an abscess), reserving an appendectomy for those not responding or with recurrent disease. One of the two antibiotic regiments: 1. Combination A: 1. Amoxicillin/clavulanic acid 25/2.5mg/kg 6 hourly (total 100/10 mg/kg daily. Maximum 6000/600mg a day) for children <40 kg OR Amoxicillin/clavulanic acid 1000/200mg/kg 8 hourly (total 3000/6000 mg/kg daily) for children > 40 kg 2. Gentamicin 7mg/kg once daily 2. Combination B: 1. Cefuroxim 25 mg/kg 6 hourly (total 100 mg/kg/day. Maximum 6gram/day) 2. Metronidazole 10mg/kg 8hourly (total 30 mg/kg/day. Maximum 4000 mg/day) In case of peri-appendicular abscess the decision can be made to perform a drainage procedure either percutaneously or surgical. | Procedure or surgery | Complex appendicitis with abscess or mass formation |
| Direct appendectomylaparoscopic or open appendectomy as described | Procedure or surgery | Complex appendicitis with abscess or mass formation |
Primary outcome
Overall complications
Time frame: 3 months
The proportion of patients experiencing any complication within 3 months after inclusion
19 secondary outcomes
Postappendectomy abscess
Time frame: 3 months
Superficial Site Infection
Time frame: 3 months
Secondary bowel obstruction
Time frame: 3 months
Days absent from school, social or sports events
Time frame: 30 days, 3 months
Number of days absent from work
Time frame: 30 days, 3 months
Total number of extra visits
Time frame: 30 days, 3 months
Length of hospital stay
Time frame: 3 months
Level of pain
Time frame: at inclusion/baseline (=day 0), 3 days, 5 days, 30 days, 3 months
Pain medication utilization
Time frame: 30 days, 3 months
Need for appendectomy
Time frame: 3 months
Recurrent appendicitis
Time frame: 3 months
Early failure of non-operative treatment
Time frame: 3 months
Quality of Life questionnaire (EQ-5d-Youth/EQ-5d-Proxy)
Time frame: at inclusion/baseline (=day 0), 30 days, 3 months
Quality of Life questionnaire (PedsQL 4.0)
Time frame: at inclusion/baseline (=day 0), 30 days, 3 months
Medical costs (iMCQ)
Time frame: at inclusion/baseline (=day 0), 30 days, 3 months
Non-medical / indirect costs (iPCQ)
Time frame: at inclusion/baseline (=day 0), 30 days, 3 months
Quality adjusted life months (QALM's)
Time frame: 3 months
Patient satisfaction questionnaire (PSQ-18)
Time frame: 3 months
Patient satisfaction questionnaire (Net promotor score)
Time frame: 3 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 30 Jul 2024.
- Derived from this study: PubMed 35177453van Amstel P, Bakx R, van der Lee JH, van der Weide MC, Eekelen RV, Derikx JPM, van Heurn ELW, Gorter RR; CAPP collaborative study group. Identification of the optimal treatment strategy for complex appendicitis in the paediatric population: a protocol for a multicentre prospective cohort study (CAPP study). BMJ Open. 2022 Feb 17;12(2):e054826. doi: 10.1136/bmjopen-2021-054826.
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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 Gorter, MD PhD principal investigator
Amsterdam UMC
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Appendix Mass, run by Ramon Gorter at 32 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 9 inclusion and 2 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 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Overall complications (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755179, which also lists 1 linked publication.
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 30 Jul 2024.