Conservative Treatment of Acute Appendicitis in Children

NCT ID: NCT01572558

Last Updated: 2012-10-17

Basic Information

• 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

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.

Conditions

Appendicitis; Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

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

Eligibility Criteria

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

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan Svensson

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan F Svensson, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Astrid Lindgren Children´s Hospital

Stockholm, , Sweden

Countries

Sweden

References

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

EA2011/4:8

Identifier Type: -

Identifier Source: org_study_id