Perforated Appendicitis With Delayed Presentation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2015 by Jacob Langer, The Hospital for Sick Children.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Jacob Langer, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT01068288

First received: February 11, 2010

Last updated: May 29, 2015

Last verified: May 2015

History of Changes

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 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:

MedlinePlus related topics: Appendicitis

U.S. FDA Resources

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

Primary Outcome Measures:

Length of stay in hospital [ Time Frame: 2 years ]

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


Estimated Enrollment:	60
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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 (Child, Adult)
Sexes Eligible for Study:	All
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: Eveline Lapidus-Krol, RN, MSc	416-813-306542	eveline.lapidus-krol@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


Responsible Party:	Jacob Langer, Staff Surgeon, 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:	May 29, 2015

Keywords provided by Jacob Langer, The Hospital for Sick Children:


laparoscopic appendectomy open appendectomy expectant management paediatric

Additional relevant MeSH terms:


Appendicitis Intraabdominal Infections Infection Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases

ClinicalTrials.gov processed this record on July 27, 2017

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