Perforated Appendicitis With Delayed Presentation
|ClinicalTrials.gov Identifier: NCT01068288|
Recruitment Status : Unknown
Verified May 2015 by Jacob Langer, The Hospital for Sick Children.
Recruitment status was: Recruiting
First Posted : February 12, 2010
Last Update Posted : June 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Procedure: Laparoscopic or open appendectomy Procedure: Expectant Management||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
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|
- Length of stay in hospital [ Time Frame: 2 years ]
- 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 ]
- Time to full parenteral intake. [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ]
- Duration of narcotics [ Time Frame: Daily until hospital discharge, 6 months, 12 months ]
- Duration of antibiotics [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ]
- Total dose or radiation exposure [ Time Frame: All hospital visits until 12 months following initial discharge ]
- Time to return to usual activity [ Time Frame: Daily until hospital discharge, 12 months ]
- Cost [ Time Frame: 12 months following initial discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068288
|Contact: Eveline Lapidus-Krol, RN, MScfirstname.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|