Early Versus Delayed Operation for Perforated Appendicitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Appendiceal Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Drainage with interval appendectomy

Group Type ACTIVE_COMPARATOR

Drainage and Interval Appendectomy

Intervention Type PROCEDURE

drainage with interval appendectomy

2

appendectomy on presentation

Group Type EXPERIMENTAL

Operation on Admission

Intervention Type PROCEDURE

Laparoscopic appendectomy on admission

Interventions

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Operation on Admission

Laparoscopic appendectomy on admission

Intervention Type PROCEDURE

Drainage and Interval Appendectomy

drainage with interval appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No