Perforated Appendicitis With Delayed Presentation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01068288
First received: February 11, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention Phase
Appendicitis
Procedure: Laparoscopic or open appendectomy
Procedure: Expectant Management
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Length of stay in hospital [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068288

Contacts
Contact: Aimee Pastor, RN 416-813-7654 ext 6542 aimee.pastor@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

No publications provided

Responsible Party: Jacob Langer, MD, The Hospital For Sick Children
ClinicalTrials.gov Identifier: NCT01068288     History of Changes
Other Study ID Numbers: 1000013658
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
laparoscopic appendectomy
open appendectomy
expectant management
paediatric

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014