Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2018-11-05
2023-03-30
Brief Summary
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Detailed Description
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Early appendectomy in patients diagnosed with acute appendicitis has been a mainstay of treatment. Timely intervention is recommended to avoid the risks associated with perforated appendicitis, which has been shown to increase the risk of post-operative complications compared to non-perforated appendicitis. However, some studies have suggested that delaying appendectomy does not increase complications. Several studies have also assessed the safety of nighttime operating with conflicting results. Some suggest that delaying surgery until daytime is safe.
This study is a prospective, randomized controlled trial with blinding of the outcome assessors. Eligible participants will be adult patients diagnosed with acute appendicitis with an expected operative start time between 2000-0400. Patients randomized to the intervention group will have delayed surgery after 0530 the following morning to avoid nighttime operating. Patients randomized to the control group will receive immediate surgery within 6 hours of the decision to operate. The follow up period will be a minimum of 30 days. Independent outcome assessors will assess patients during their postoperative course in hospital as well as in the outpatient follow up clinic.
The primary outcome for this study is complication occurring within 30 days of surgery. Complication includes any of the following: mortality, readmission to hospital, emergency department (ED) visit, percutaneous drain insertion, reoperation, prolonged hospital stay greater than 7 days, and a predefined list of postoperative complications. Secondary outcomes include perforated appendicitis, operative time, and length of stay.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Delayed Appendectomy
Patients will undergo appendectomy the morning following the decision to operate. This group will have an anticipated delay between 3 - 14 hours from the decision to operate, with a surgical start time between 0530 - 0900.
Appendectomy
Appendectomy is the surgical removal of the appendix.
Immediate Appendectomy
Patients will undergo appendectomy within 6 hours of the decision to operate. Surgery will take place between 2000 - 0400.
Appendectomy
Appendectomy is the surgical removal of the appendix.
Interventions
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Appendectomy
Appendectomy is the surgical removal of the appendix.
Eligibility Criteria
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Inclusion Criteria
* Imaging confirmed diagnosis of appendicitis (ultrasound or CT or MRI)
* Expected time of operation between 2200 - 0400 and occurs within 6 hours of the decision to operate
Exclusion Criteria
* Patients with suspected sepsis
* Unknown diagnosis
* Presence of abscess on CT Scan
* Diagnosis of missed appendicitis
* Pregnancy
* Patients who are not surgical candidates
* Patients who are not competent to sign consent
18 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
Queen's University
OTHER
Responsible Party
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Sunil Patel
Associate Professor
Locations
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Kingston Health Sciences Centre
Kingston, Ontario, Canada
Countries
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References
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Patel SV, Zhang L, Mir ZM, Lemke M, Leeper WR, Allen LJ, Walser E, Vogt K. Delayed Versus Early Laparoscopic Appendectomy for Adult Patients With Acute Appendicitis: A Randomized Controlled Trial. Ann Surg. 2024 Jan 1;279(1):88-93. doi: 10.1097/SLA.0000000000005996. Epub 2023 Jul 13.
Other Identifiers
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SURG-402-17
Identifier Type: -
Identifier Source: org_study_id
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