AppendicitisNCT01068288
Perforated Appendicitis With Delayed Presentation
A study testing Laparoscopic or open appendectomy and Expectant Management in people with Appendicitis, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Laparoscopic or open appendectomy and Expectant Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)
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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- Laparoscopic or open appendectomy, Expectant Management
- Keywords
- laparoscopic appendectomy, open appendectomy, expectant management, paediatric
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or open appendectomyProcedure or surgery
Expectant ManagementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Expectant Management | Experimental | Expectant Management Receives: Procedure: Expectant Management |
| Operative management | Experimental | Operative management Receives: Procedure: Laparoscopic or open appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in hospital
Measured: 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
Measured: Daily until hospital discharge
Time to full parenteral intake.
Measured: Daily until hospital discharge, 6 weeks, 12 months
Duration of narcotics
Measured: Daily until hospital discharge, 6 months, 12 months
Duration of antibiotics
Measured: Daily until hospital discharge, 6 weeks, 12 months
Total dose or radiation exposure
Measured: All hospital visits until 12 months following initial discharge
Time to return to usual activity
Measured: Daily until hospital discharge, 12 months
Cost
Measured: 12 months following initial discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Unable to recruit adequate number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Langer, The Hospital for Sick Children
- Investigators
- Jacob Langer, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068288
- Sponsor's protocol ID
- 1000013658
- Status last verified
- Jun 2018
- First submitted
- 11 Feb 2010
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforated Appendicitis With Delayed Presentation: Laparoscopic Appendectomy vs Expectant Management. A Randomized Clinical Trial (The PADLE Trial)
- ClinicalTrials.gov ID
- NCT01068288
- Acronym / sponsor ID
- 1000013658
- Conditions
- Appendicitis
- Keywords
- laparoscopic appendectomy, open appendectomy, expectant management, paediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit adequate number of patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectant Management | Experimental | Procedure: Expectant ManagementExpectant Management |
| Operative management | Experimental | Procedure: Laparoscopic or open appendectomyOperative management |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic or open appendectomy | Procedure or surgery | Operative management |
| Expectant ManagementA 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. | Procedure or surgery | Expectant Management |
Primary outcome
Length of stay in hospital
Time frame: 2 years
7 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Unable to recruit adequate number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Langer, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic or open appendectomy and Expectant Management in people with Appendicitis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit adequate number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in hospital (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.