Appendix DiseasesCALAPNCT07385261
Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery
A study testing laparoscopic appendectomy in people with Appendix Diseases and Surgery, run by Mohammad Daboos at 1 site in Egypt.
Trial summary
Observational retrospective study included 765 children with Operative management by laparoscopic appendectomy, conservative management for appendicular mass and drainage of abscess by IR should be tried first. Interval appendectomy is reserved only for patients with recurrent symptoms. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Appendix Diseases, Surgery
- What is being tested?
- laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 1 Jan 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- laparoscopic management of Complicated Appendicitis with mass formation
- laparoscopic management of Complicated appendicitis with abscess formation:
- laparoscopic management of Complicated appendicitis with free intraperitoneal collection
Who cannot join
- Open surgery cases
- Patients received incomplete antibiotic therapy
- Accidental discovery coexistent pathology that necessitates open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery. Ten Years of Multicenter Cohort Study
Observational retrospective study included 765 children with Operative management by laparoscopic appendectomy, conservative management for appendicular mass and drainage of abscess by IR should be tried first. Interval appendectomy is reserved only for patients with recurrent symptoms. the study collect the Diagnostic data ,intraoperative and post operative data to submit the strategies of laparoscopic management in limited resources setting.
Read the detailed description
Background and study aims: In children with complicated appendicitis significant morbidity exists with prolonged hospitalization and increased costs. The management strategy for complicated pediatric appendicitis differs depending on facility resources together with surgeon's experience. Various studies investigated the usefulness of laparoscopic than open surgery even in complicated appendicitis. However, the treatment strategy remains controversial, especially in appendicular mass as well as appendicular abscess.
Methods: This observational study included 765 children with complicated appendicitis. over 10 years period. Patients' demographics, clinical criteria for different presentations of complicated appendicitis, diagnostic work up, plans of treatment based on laparoscopic management were reviewed and analyzed regarding different variables and postoperative outcomes.
- Conditions
- Appendix Diseases, Surgery
- Being tested
- laparoscopic appendectomy
- Keywords
- laparoscopic surgery, complicated appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
Based on clinical findings, imaging studies and laboratory findings, after resuscitation, the decision of urgent surgery was according to the presentation Free peritoneal perforation (FPA) Perforated appendicitis with free peritoneal fluid were managed by urgent laparoscopic exploration Appendicular mass (AM) In patients presented by early mass formation lap exploration was carried out but trial of conservative management was planned for cases presented late with expected difficulty in lap dissection depending on surgical team and parental consultation, this accomplished by (nothing per mouth, I V fluid, I V antibiotic, temperature chart with U/S and biomarker follow up)
Appendicular abscess (AAbs) Percutaneous drainage by availability IR team was the first choice however lap exploration and /or lap assisted extraperitoneal drainage was the second choice if IR failed or not available.
| Study group | Role | What they receive |
|---|---|---|
| Complicated Appendicitis | Experimental | Complicated appendicitis: refer to acute appendicitis with perforation or gangrene, appendicular mass with or without abdominal abscess formation submitted for laparoscopic management with appendectomy and intraperitoneal suction of pus over the last 10 years Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes
postoperative outcomes any alarming symptoms of intestinal obstruction developed (vomiting, fever, or severe abdominal pain, intraperitoneal collections
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jan 2015
- Primary completion1 Jan 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendix DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Pediatric patients aged less than 18 years, with Complicated appendicitis (with mass, appendicular abscess, and free collection) received surgical intervention with laparoscopy
- Masking
- None (open label)
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Daboos
- Sponsor type
- University, hospital or other
- Collaborators
- South Valley University, Tanta University
- Responsible party
- Sponsor-investigator, Mohammad Daboos, Al-Azhar University
- Investigators
- Mohammad Daboos, Dr, Principal investigator, Department of pediatric surgery, faculty of medicine , Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385261
- Sponsor's protocol ID
- SUV-MED- SUR011-4-25-3-2
- Acronym
- CALAP
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery. Ten Years of Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07385261
- Acronym / sponsor ID
- CALAP / SUV-MED- SUR011-4-25-3-2
- Conditions
- Appendix Diseases, Surgery
- Keywords
- laparoscopic surgery, complicated appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Mohammad DaboosUniversity, hospital or other
- Collaborators
- South Valley University, Tanta University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 4 Feb 2026 (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.
Observational retrospective study included 765 children with Operative management by laparoscopic appendectomy, conservative management for appendicular mass and drainage of abscess by IR should be tried first. Interval appendectomy is reserved only for patients with recurrent symptoms. the study collect the Diagnostic data ,intraoperative and post operative data to submit the strategies of laparoscopic management in limited resources setting.
Detailed description
Background and study aims: In children with complicated appendicitis significant morbidity exists with prolonged hospitalization and increased costs. The management strategy for complicated pediatric appendicitis differs depending on facility resources together with surgeon's experience. Various studies investigated the usefulness of laparoscopic than open surgery even in complicated appendicitis. However, the treatment strategy remains controversial, especially in appendicular mass as well as appendicular abscess.
Methods: This observational study included 765 children with complicated appendicitis. over 10 years period. Patients' demographics, clinical criteria for different presentations of complicated appendicitis, diagnostic work up, plans of treatment based on laparoscopic management were reviewed and analyzed regarding different variables and postoperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Pediatric patients aged less than 18 years, with Complicated appendicitis (with mass, appendicular abscess, and free collection) received surgical intervention with laparoscopy
| Arm | Type | Receives |
|---|---|---|
| Complicated Appendicitis | Experimental | Procedure: laparoscopic appendectomyComplicated appendicitis: refer to acute appendicitis with perforation or gangrene, appendicular mass with or without abdominal abscess formation submitted for laparoscopic management with appendectomy and intraperitoneal suction of pus over the last 10 years |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- laparoscopic management of Complicated Appendicitis with mass formation
- laparoscopic management of Complicated appendicitis with abscess formation:
- laparoscopic management of Complicated appendicitis with free intraperitoneal collection
Key exclusion criteria (3 listed)
- Open surgery cases
- Patients received incomplete antibiotic therapy
- Accidental discovery coexistent pathology that necessitates open surgery
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 appendectomyBased on clinical findings, imaging studies and laboratory findings, after resuscitation, the decision of urgent surgery was according to the presentation Free peritoneal perforation (FPA) Perforated appendicitis with free peritoneal fluid were managed by urgent laparoscopic exploration Appendicular mass (AM) In patients presented by early mass formation lap exploration was carried out but trial of conservative management was planned for cases presented late with expected difficulty in lap dissection depending on surgical team and parental consultation, this accomplished by (nothing per mouth, I V fluid, I V antibiotic, temperature chart with U/S and biomarker follow up) Appendicular abscess (AAbs) Percutaneous drainage by availability IR team was the first choice however lap exploration and /or lap assisted extraperitoneal drainage was the second choice if IR failed or not available. | Procedure or surgery | Complicated Appendicitis |
Primary outcome
Primary outcomes
Time frame: 4 years
postoperative outcomes any alarming symptoms of intestinal obstruction developed (vomiting, fever, or severe abdominal pain, intraperitoneal collections
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 4 Feb 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. This study is not recruiting at the moment.
Mohammad Daboos, Dr principal investigator
Department of pediatric surgery, faculty of medicine , Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic appendectomy in people with Appendix Diseases and Surgery, run by Mohammad Daboos at 1 site in Egypt.
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 3 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Primary outcomes (time frame: 4 years). 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 4 Feb 2026.