Perforated Appendicitis With Delayed Presentation

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01068288
• Other study ID #: 1000013658
• Status: Terminated
• Phase: N/A
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Laparoscopic or open appendectomy

• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in hospital		2 years
Secondary	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
Secondary	Time to full parenteral intake.		Daily until hospital discharge, 6 weeks, 12 months
Secondary	Duration of narcotics		Daily until hospital discharge, 6 months, 12 months
Secondary	Duration of antibiotics		Daily until hospital discharge, 6 weeks, 12 months
Secondary	Total dose or radiation exposure		All hospital visits until 12 months following initial discharge
Secondary	Time to return to usual activity		Daily until hospital discharge, 12 months
Secondary	Cost		12 months following initial discharge