ClinicalTrials.gg
Not yet recruitingNCT06828952appendicitisUpdated Feb 17, 2025

Risk Factors of Failure of Conservative Treatment in Acute Non Complicated Appendicitis

An observational study in Conservative Management, sponsored by Ahmed Mohammed Hussein Sayed. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Ahmed Mohammed Hussein Sayed · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years to 60 Years
Sex
All
01

Study summary

From this study, it can be concluded that patients who meet the following criteria are more likely to fail expectant management and thus should not be considered for the NOM of uncomplicated acute appendicitis. These include the duration of symptoms before presenting to a surgical emergency , the presence of fever within 24 hours of presenting to a surgical emergency, TLC cells/dL, CRP mg/L, appendix diameter mm, modified Alvarado score , and adult appendicitis score .

Read the detailed description

Expectant management with intravenous antibiotic therapy alone has emerged as an effective alternative to appendectomy for the treatment of uncomplicated acute appendicitis . It is important to identify patients at the onset of the disease who are likely to have successful outcomes for conservative management.

02

Conditions studied

  • Conservative Management

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Keywords

  • Appendicitis
03

In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 151 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

This is the only study on the registry with Ahmed Mohammed Hussein Sayed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Male or female patients é diagnosis of acute appendicitis Patients with ages: from 16 to 60 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patients é diagnosis of acute appendicitis .
  • Patients with ages: from 16 to 60 years old.

Exclusion criteria

Exclusion Criteria:

  • complicated AA (appendicolith, perforation, peri appendicular abscess or suspicion of a tumor).
  • inflammatory bowel disease.
  • inability to co-operate and give .
  • diffuse peritonitis.
  • antibiotic documented allergy \& allergy to contrast media .
  • Patients with serious comorbid conditions DM \& renal insufficiency, serum creatinine > 150 μmol/l .
  • Pregnant \& lactating patient.
  • Patients with bleeding diathesis and those on anticoagulants.
  • Patients with advanced \& patient on drugs .
  • Patients with previous appendectomy.
  • Extreme of age.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
2 Days
Patient registry
Yes

Groups and cohorts

  • (1) Male or female patients é diagnosis of acute appendicitis.

    Patients who presented with complaints of right lower quadrant pain with symptoms and signs strongly suggestive of uncomplicated acute appendicitis that was confirmed on ultrasonography, were included. The modified Alvarado score and adult appendicitis score were calculated.

    Drug: ceftriaxone · Drug: ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

Interventions

  • ceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

  • Drugceftriaxone 1 gm/12 hourly and IV metronidazole 500 mg/8 hourly

    Conservative management

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What researchers measure

Primary outcomes

  1. Risk factors of failure of conservative treatment in acute non complicated appendicitis

    modified Alvarado score and adult appendicitis score

    Time frame: One year

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Study locations

1 site
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References and documents

Publications

  • Shindoh J, Niwa H, Kawai K, Ohata K, Ishihara Y, Takabayashi N, Kobayashi R, Hiramatsu T. Predictive factors for negative outcomes in initial non-operative management of suspected appendicitis. J Gastrointest Surg. 2010 Feb;14(2):309-14. doi: 10.1007/s11605-009-1094-1. PubMed 19936849 ↗
  • Hansson J, Khorram-Manesh A, Alwindawe A, Lundholm K. A model to select patients who may benefit from antibiotic therapy as the first line treatment of acute appendicitis at high probability. J Gastrointest Surg. 2014 May;18(5):961-7. doi: 10.1007/s11605-013-2413-0. Epub 2013 Nov 22. PubMed 24263678 ↗
  • Walker C, Moosavi A, Young K, Fluck M, Torres D, Widom K, Wild J. Factors Associated with Failure of Nonoperative Management for Complicated Appendicitis. Am Surg. 2019 Aug 1;85(8):865-870. PubMed 31560305 ↗
  • Loftus TJ, Brakenridge SC, Croft CA, Stephen Smith R, Efron PA, Moore FA, Mohr AM, Jordan JR. Successful nonoperative management of uncomplicated appendicitis: predictors and outcomes. J Surg Res. 2018 Feb;222:212-218.e2. doi: 10.1016/j.jss.2017.10.006. Epub 2017 Nov 13. PubMed 29146455 ↗
  • Cervellin G, Mora R, Ticinesi A, Meschi T, Comelli I, Catena F, Lippi G. Epidemiology and outcomes of acute abdominal pain in a large urban Emergency Department: retrospective analysis of 5,340 cases. Ann Transl Med. 2016 Oct;4(19):362. doi: 10.21037/atm.2016.09.10. PubMed 27826565 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2025, 5 months later.

Of 54 non-industry observational studies under Appendicitis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 5 months is below that.

Counting every sponsor, half of 56 studies reached it within 23 months; a quarter within 7 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2024
First posted
Feb 17, 2025
StartEst.
Jun 22, 2025
Primary completionEst.
Dec 1, 2025
CompletionEst.
Dec 2, 2025
Last update
Feb 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06828952
Lead sponsor
Ahmed Mohammed Hussein Sayed
Collaborators
Assiut University
Responsible party
Ahmed Mohammed Hussein Sayed (Principal investigator, Assiut University) — Sponsor-investigator
First posted
Feb 17, 2025
Start date
Jun 22, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 2, 2025 (estimated)
Last update
Feb 17, 2025

Study contacts

Ahmed Mohammed Hussein Sayed Ahmed Razeen, MBBCh
Contact
Ahmed.16266245@med.aun.edu.eg
+2001099414358
Mohamed Taher Gamal Amin Taher, MBBCh &MD &PHD
Contact
mohamedamin022@aun.edu.eg
+2001091289046

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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