Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Length of stay in hospital
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Expectant Management
Expectant Management
Intervention: Expectant Management (Procedure)
Operative management
Operative management
Intervention: Laparoscopic or open appendectomy (Procedure)
Outcomes
Primary Outcomes
Length of stay in hospital
Time Frame: 2 years
Secondary Outcomes
- Total dose or radiation exposure(All hospital visits until 12 months following initial discharge)
- 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)
- Time to return to usual activity(Daily until hospital discharge, 12 months)
- Cost(12 months following initial discharge)
Investigators
Jacob Langer
Staff Surgeon
The Hospital for Sick Children