Perforated Appendicitis With Delayed Presentation

NCT01068288 | Terminated DMC

• 1 other identifier: 1000013658
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

laparoscopic appendectomy; open appendectomy; expectant management; paediatric

Outcome Measures

Primary Outcomes (1)

• Length of stay in hospital

  2 years

Secondary Outcomes (7)

• 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

Study Arms (2)

Expectant Management

EXPERIMENTAL

Expectant Management

Procedure: Expectant Management

Operative management

EXPERIMENTAL

Operative management

Procedure: Laparoscopic or open appendectomy

Interventions

Laparoscopic or open appendectomy PROCEDURE

Operative management

Expectant Management PROCEDURE

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.

Expectant Management

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Laparoscopy; Watchful Waiting

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Jacob Langer, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

CA (1)