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Perforated Appendicitis With Delayed Presentation

Primary Purpose

Appendicitis

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Laparoscopic or open appendectomy

Expectant Management

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring laparoscopic appendectomy, open appendectomy, expectant management, paediatric

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Expectant Management

Operative management

Arm Description

Expectant Management

Operative management

Outcomes

Primary Outcome Measures

Length of stay in hospital

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 to full parenteral intake.

Duration of narcotics

Duration of antibiotics

Total dose or radiation exposure

Time to return to usual activity

Cost

Full Information

NCT ID

NCT01068288

First Posted

February 11, 2010

Last Updated

June 5, 2018

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT01068288

Brief Title

Perforated Appendicitis With Delayed Presentation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit adequate number of patients

Study Start Date

July 2009 (Actual)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis

Keywords

laparoscopic appendectomy, open appendectomy, expectant management, paediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Expectant Management

Arm Type

Experimental

Arm Description

Expectant Management

Arm Title

Operative management

Arm Type

Experimental

Arm Description

Operative management

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic or open appendectomy

Intervention Type

Procedure

Intervention Name(s)

Expectant Management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Length of stay in hospital

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Title

Time to full parenteral intake.

Time Frame

Daily until hospital discharge, 6 weeks, 12 months

Title

Duration of narcotics

Time Frame

Daily until hospital discharge, 6 months, 12 months

Title

Duration of antibiotics

Time Frame

Daily until hospital discharge, 6 weeks, 12 months

Title

Total dose or radiation exposure

Time Frame

All hospital visits until 12 months following initial discharge

Title

Time to return to usual activity

Time Frame

Daily until hospital discharge, 12 months

Title

Cost

Time Frame

12 months following initial discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob Langer, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

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Perforated Appendicitis With Delayed Presentation

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