NCT01068288

Perforated Appendicitis With Delayed Presentation

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic or open appendectomy
PROCEDURE	Expectant Management	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-02-12
• Last updated: 2018-06-07

Locations

1 site across 1 country: Canada