Perforated Appendicitis With Delayed Presentation

Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)

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.

Study Overview

• Status: Terminated
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: Expectant 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of stay in hospital	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Daily until hospital discharge
Time to full parenteral intake.	Daily until hospital discharge, 6 weeks, 12 months
Duration of narcotics	Daily until hospital discharge, 6 months, 12 months
Duration of antibiotics	Daily until hospital discharge, 6 weeks, 12 months
Total dose or radiation exposure	All hospital visits until 12 months following initial discharge
Time to return to usual activity	Daily until hospital discharge, 12 months
Cost	12 months following initial discharge

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: paediatric; laparoscopic appendectomy; expectant management; open appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 1000013658