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Perforated Appendicitis With Delayed Presentation

T

The Hospital for Sick Children

Status

Terminated

Conditions

Appendicitis

Treatments

Procedure: Expectant Management
Procedure: Laparoscopic or open appendectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01068288
1000013658

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Expectant Management
Experimental group
Description:
Expectant Management
Treatment:
Procedure: Expectant Management
Operative management
Experimental group
Description:
Operative management
Treatment:
Procedure: Laparoscopic or open appendectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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