Early Versus Delayed Operation for Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00414375
First received: December 19, 2006
Last updated: March 2, 2009
Last verified: March 2009
  Purpose

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 Intervention
Appendiceal Abscess
Procedure: Operation on Admission
Procedure: Drainage and Interval Appendectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Pilot [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00414375

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

No publications provided

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00414375     History of Changes
Other Study ID Numbers: 06 11 164
Study First Received: December 19, 2006
Last Updated: March 2, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Abscess
Appendicitis
Suppuration
Infection
Inflammation
Pathologic Processes
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 01, 2014