Conservative Treatment of Acute Appendicitis in Children

NCT01572558 | Completed

• 1 other identifier: EA2011/4:8
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Appendectomy; Nonsurgical treatment with antibiotics

Outcome Measures

Primary Outcomes (1)

• Resolution of symptoms without significant complications

  This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus \>5 days, length of stay \>7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.

  30 days

Secondary Outcomes (5)

• Time in hospital

  7 days

• Time to resolution of symptoms

  7 days

• Abscess formation

  7 days

• Early complications

  7 days

• Pain

  48 hours

Study Arms (2)

Appendectomy

ACTIVE COMPARATOR

Standard surgical treatment, appendectomy

Procedure: Appendectomy

Conservative, non-surgical treatment

EXPERIMENTAL

Non-operative treatment with intravenous and oral antibiotics

Drug: Conservative, non-surgical treatment

Interventions

Appendectomy PROCEDURE

Standard surgical treatment, normally laparoscopic appendectomy

Also known as: Open appendectomy, Laparoscopic appendectomy

Appendectomy

Conservative, non-surgical treatment 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.

Also known as: Meronem®, Meropenem, Flagyl®, Metronidazol, Ciproxin®, Ciprofloxacin

Conservative, non-surgical treatment

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Astrid Lindgren Children´s Hospital

Stockholm, 17176, Sweden

Location

Related Publications (2)

• 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.

  PMID: 31800496 DERIVED

• 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.

  PMID: 25072441 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy; Meropenem; Metronidazole; Benchmarking; Ciprofloxacin

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Jan F Svensson, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: April 6, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

SE (1)