Perforated Appendicitis With Delayed Presentation

Study Overview
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Brief Summary
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There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.

Detailed Description
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The ability of clinical practice guidelines to improve clinical practice and optimize resource utilization continues to be substantiated in the literature. To be effective, clinical practice guidelines must be developed from reliable and reproducible data. This trial prospectively compares expectant management versus immediate laparoscopic or open appendectomy for perforated appendicitis in children with a delayed diagnosis. The primary outcome measure is length of hospital stay.

Official Title
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Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: Laparoscopic or open appendectomy
* Procedure: Expectant Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started. Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon. Consent to participate Exclusion Criteria: Uncertainty about the diagnosis. The need for laparotomy for another reason. Free intraperitoneal air on imaging. Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis. Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expectant Management<br>Expectant Management | Procedure: Expectant Management<br>* A consult to Interventional Radiology will be made at the time of admission to determine whether percutaneous drainage is feasible, and if it is the abscess will be drained by Interventional Radiology. Ultrasound and/or CT scan will be used to follow the abscess collections and/or phlegmons and guide the removal of drains. For patients with a fecalith on imaging, a laparoscopic interval appendectomy will be performed 6-12 weeks following discharge from hospital. For those without a fecalith on imaging, a decision will be made by the family, with the guidance of the surgeon, whether or not to undergo a laparoscopic interval appendectomy.<br>|
| Experimental: Operative management<br>Operative management | Procedure: Laparoscopic or open appendectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications recurrent abscess, recurrent admissions related to the disease,small bowel obstruction, injury to bowel, blood loss and transfusion requirement, failure of the conservative approach |  | Daily until hospital discharge | 
| Time to full parenteral intake. |  | Daily until hospital discharge, 6 weeks, 12 months | 
| Duration of narcotics |  | Daily until hospital discharge, 6 months, 12 months | 
| Duration of antibiotics |  | Daily until hospital discharge, 6 weeks, 12 months | 
| Total dose or radiation exposure |  | All hospital visits until 12 months following initial discharge | 
| Time to return to usual activity |  | Daily until hospital discharge, 12 months | 
| Cost |  | 12 months following initial discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic appendectomy, open appendectomy, expectant management, paediatric