NCT07385261

Brief 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. the study collect the Diagnostic data ,intraoperative and post operative data to submit the strategies of laparoscopic management in limited resources setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
765

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

laparoscopic surgerycomplicated appendicitis

Outcome Measures

Primary Outcomes (1)

  • Primary outcomes

    postoperative outcomes any alarming symptoms of intestinal obstruction developed (vomiting, fever, or severe abdominal pain, intraperitoneal collections

    4 years

Study Arms (1)

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

Procedure: laparoscopic appendectomy

Interventions

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.

Complicated Appendicitis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Open surgery cases
  • Patients received incomplete antibiotic therapy
  • Accidental discovery coexistent pathology that necessitates open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammad Daboos

Cairo, 115678, Egypt

Location

Study Officials

  • ‪Mohammad Daboos‬, Dr

    Department of pediatric surgery, faculty of medicine , Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of pediatric surgery, Faculty of Medicine, Al-Azhar University

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

January 1, 2015

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations