Clinical trial NCT01068288: Perforated Appendicitis With Delayed Presentation
Official title: Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Appendicitis
Keywords: laparoscopic appendectomy
open appendectomy
expectant management
paediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of stay in hospital
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: Daily until hospital discharge
measure: Time to full parenteral intake.
timeFrame: Daily until hospital discharge, 6 weeks, 12 months
measure: Duration of narcotics
timeFrame: Daily until hospital discharge, 6 months, 12 months
measure: Duration of antibiotics
timeFrame: Daily until hospital discharge, 6 weeks, 12 months
measure: Total dose or radiation exposure
timeFrame: All hospital visits until 12 months following initial discharge
measure: Time to return to usual activity
timeFrame: Daily until hospital discharge, 12 months
measure: Cost
timeFrame: 12 months following initial discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jacob Langer, MD
role: PRINCIPAL_INVESTIGATOR
References: