NCT06834958

Brief Summary

The aim of this study is to describe the proportion of pa-tients with normal preoperative inflammatorymarkers among patients with histopathologically proven acute appendicitis

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress36%
Jan 2025Oct 2028

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

January 31, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Clinical diagnosis of acute appendicitis

Outcome Measures

Primary Outcomes (1)

  • Surgery done if needed

    Patient with acute appendicitis and normal WBCS count will be under observation for while but people with evidence on imaging and high inflammatory markers will go under surgery

    Days of hospital reservation

Study Arms (1)

Patient included who have acute appendicitis clinically and normal WBCS count

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

Open surgery for appendix which is inflamed

Patient included who have acute appendicitis clinically and normal WBCS count

Eligibility Criteria

Age14 Days - 60 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study not need special type of people

You may qualify if:

  • Male or female patients é clinically diagnosed acute appendicitis with normal WBCS

You may not qualify if:

  • complicated AA (perforation, peri appendicular abscess or suspicion of a tumor.
  • \_inflammatory bowel diseases 3\_inability to co-operate and give informed consent 4\_diffuse peritonitis 5\_Patients with serious comorbid conditions DM \& renal insufficiency, serum creatinine \> 150 μmol/l 6\_Pregnant \& lactating patient 7\_Patients with advanced malignancies \& pt on immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 19, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Locations