Perforated Appendicitis With Delayed Presentation

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Appendicitis	Procedure: Laparoscopic or open appendectomy; Procedure: Expectant Management	Phase 2

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Expectant Management; 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; Operative management	Procedure: Laparoscopic or open appendectomy

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Length of stay in hospital [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. 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 ]
2. Time to full parenteral intake. [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ]
3. Duration of narcotics [ Time Frame: Daily until hospital discharge, 6 months, 12 months ]
4. Duration of antibiotics [ Time Frame: Daily until hospital discharge, 6 weeks, 12 months ]
5. Total dose or radiation exposure [ Time Frame: All hospital visits until 12 months following initial discharge ]
6. Time to return to usual activity [ Time Frame: Daily until hospital discharge, 12 months ]
7. Cost [ Time Frame: 12 months following initial discharge ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Eveline Lapidus-Krol, RN, MSc	416-813-306542	eveline.lapidus-krol@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada
Principal Investigator: Jacob Langer, MD
Sub-Investigator: Ahmed Nasr, MD
Sub-Investigator: Aimee Pastor, RN

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:	Jacob Langer, MD	The Hospital for Sick Children

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jacob Langer, Staff Surgeon, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT01068288 History of Changes
Other Study ID Numbers:	1000013658
First Posted:	February 12, 2010
Last Update Posted:	June 1, 2015
Last Verified:	May 2015

Keywords provided by Jacob Langer, The Hospital for Sick Children:

laparoscopic appendectomy; open appendectomy; expectant management; paediatric

Additional relevant MeSH terms:

Appendicitis; Intraabdominal Infections; Infection; Gastroenteritis	Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases