MedDataX Logo

Conservative Treatment of Acute Appendicitis in Children

NCT ID: NCT01572558

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis Child

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Appendectomy Nonsurgical treatment with antibiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Appendectomy

Standard surgical treatment, appendectomy

Group Type ACTIVE_COMPARATOR

Appendectomy

Intervention Type PROCEDURE

Standard surgical treatment, normally laparoscopic appendectomy

Conservative, non-surgical treatment

Non-operative treatment with intravenous and oral antibiotics

Group Type EXPERIMENTAL

Conservative, non-surgical treatment

Intervention Type DRUG

Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Appendectomy

Standard surgical treatment, normally laparoscopic appendectomy

Intervention Type PROCEDURE

Conservative, non-surgical treatment

Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Open appendectomy Laparoscopic appendectomy Meronem® Meropenem Flagyl® Metronidazol Ciproxin® Ciprofloxacin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention

Exclusion Criteria

* Suspicion of perforated appendicitis on the basis of generalized peritonitis
* An appendiceal mass, diagnosed either by palpation or with radiology
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jan Svensson

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan F Svensson, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Astrid Lindgren Children´s Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646.

Reference Type DERIVED
PMID: 31800496 (View on PubMed)

Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835.

Reference Type DERIVED
PMID: 25072441 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EA2011/4:8

Identifier Type: -

Identifier Source: org_study_id