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Completed

NCT Number: NCT01572558

Conservative Treatment of Acute Appendicitis in Children

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.

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Key information

Conditions

Appendicitis Cecal Diseases Child Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astrid Lindgren Children´s Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Appendectomy

Procedure

Standard surgical treatment, normally laparoscopic appendectomy

Other names: Open appendectomy, Laparoscopic 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.

Other names: Meronem®, Meropenem, Flagyl®, Metronidazol, Ciproxin®, Ciprofloxacin

Primary outcomes

  1. Resolution of symptoms without significant complications

    Time frame: 30 days

    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.

Secondary outcomes

  1. Time in hospital

    Time frame: 7 days

    Number of days as inpatients after initiation of allocated treatment, ea. after randomization.

  2. Time to resolution of symptoms

    Time frame: 7 days

    In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.

  3. Abscess formation

    Time frame: 7 days

    As noted either in hospital or during follow up.

  4. Early complications

    Time frame: 7 days

    Wound infections, wound dehiscence, diarrhea etc.

  5. Pain

    Time frame: 48 hours

    Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Conservative Treatment of Acute Appendicitis in Children Pilot Trial

Acronym: CONSAPP Pilot

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2012
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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