An interventional study of Appendectomy in Appendicitis, sponsored by Kingston Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Kingston Health Sciences Centre · Not applicable, Interventional, and Treatment
The DELAY Trial will compare immediate (\< 6 hours from decision to operate) to delayed (Surgery to take place the following morning) appendectomy in adult patients presenting to the emergency department with suspected acute appendicitis. The primary outcome will be 30 day postoperative complications.
This randomized controlled trial is designed to assess the effect of timing of surgery on surgical complications in patients undergoing appendectomy for acute appendicitis at one of two participating institutions.
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.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 127 is above the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Kingston Health Sciences Centre is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Appendectomy
Patients will undergo appendectomy within 6 hours of the decision to operate. Surgery will take place between 2000 - 0400.
Procedure: Appendectomy
Appendectomy is the surgical removal of the appendix.
30 Day Post Operative Complications
Time frame: within 30 days of surgery
Perforated Appendicitis
Time frame: At time of surgery
Operative Time
Time frame: At time of surgery
Length of Stay - Index Admission
Time frame: Index Admission
Length of Stay - Index admission plus any additional admissions within 30 days of surgery
Time frame: 30 Days
Plan to share: Undecided
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Kingston Health Sciences Centre