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Early Versus Delayed Operation for Perforated Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00414375
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : March 3, 2009
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Appendiceal Abscess Procedure: Operation on Admission Procedure: Drainage and Interval Appendectomy

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study
Study Start Date : December 2006
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Appendicitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Drainage with interval appendectomy
Procedure: Drainage and Interval Appendectomy
drainage with interval appendectomy
Experimental: 2
appendectomy on presentation
Procedure: Operation on Admission
Laparoscopic appendectomy on admission

Outcome Measures

Primary Outcome Measures :
  1. Pilot [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414375

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital
More Information

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00414375     History of Changes
Other Study ID Numbers: 06 11 164
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009

Keywords provided by Children's Mercy Hospital Kansas City:
Perforated Appendicitis

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Pathologic Processes