Perforated Appendicitis With Delayed Presentation
Recruitment status was Recruiting
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.
Procedure: Laparoscopic or open appendectomy
Procedure: Expectant Management
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)|
- Length of stay in hospital [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Daily until hospital discharge ] [ Designated as safety issue: No ]
- Time to full parenteral intake. [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ] [ Designated as safety issue: No ]
- Duration of narcotics [ Time Frame: Daily until hospital discharge, 6 months, 12 months ] [ Designated as safety issue: No ]
- Duration of antibiotics [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ] [ Designated as safety issue: No ]
- Total dose or radiation exposure [ Time Frame: All hospital visits until 12 months following initial discharge ] [ Designated as safety issue: No ]
- Time to return to usual activity [ Time Frame: Daily until hospital discharge, 12 months ] [ Designated as safety issue: No ]
- Cost [ Time Frame: 12 months following initial discharge ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Expectant Management||
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.
|Experimental: Operative management||Procedure: Laparoscopic or open appendectomy|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068288
|Contact: Aimee Pastor, RN||416-813-7654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Principal Investigator: Jacob Langer, MD|
|Sub-Investigator: Ahmed Nasr, MD|
|Sub-Investigator: Aimee Pastor, RN|
|Principal Investigator:||Jacob Langer, MD||The Hospital for Sick Children|