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Completed

NCT Number: NCT00414375

Early Versus Delayed Operation for Perforated Appendicitis

The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.

The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

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Key information

Conditions

Appendiceal Abscess Abscess Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Suppuration

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.

Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.

Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
  • Children of any age will be included.

Exclusion criteria

  • Patients with immune deficiency
  • Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
  • Acute sepsis or severe pain from perforation not allowing for delayed management.

Treatment and study plan

Operation on Admission

Procedure

Laparoscopic appendectomy on admission

Drainage and Interval Appendectomy

Procedure

drainage with interval appendectomy

Primary outcomes

  1. Pilot

    Time frame: 3 months

Secondary outcomes

  1. PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 21, 2006
Registry last updated
Mar 3, 2009

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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