Perforated Appendicitis With Delayed Presentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068288
Recruitment Status : Terminated (Unable to recruit adequate number of patients)
First Posted : February 12, 2010
Last Update Posted : June 7, 2018
Information provided by (Responsible Party):
Jacob Langer, The Hospital for Sick Children

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 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)
Actual Study Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

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

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 ]

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068288

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Jacob Langer, MD The Hospital for Sick Children

Responsible Party: Jacob Langer, Staff Surgeon, The Hospital for Sick Children Identifier: NCT01068288     History of Changes
Other Study ID Numbers: 1000013658
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Keywords provided by Jacob Langer, The Hospital for Sick Children:
laparoscopic appendectomy
open appendectomy
expectant management

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases