(D)Elayed vs. (E)Arly (L)Aparoscopic (A)Ppendectom(Y)

Appendicitis Clinical Trial

— DELAY  

Official title:

Delayed vs. Early Laparoscopic Appendectomy : A Randomized Controlled Trial (The DELAY Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524573
• Other study ID #: SURG-402-17
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients = 18 years of age

• 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 hemodynamic instability

• 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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Appendectomy
Appendectomy is the surgical removal of the appendix.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Patel SV, Zhang L, Mir ZM, Lemke M, Leeper WR, Allen LJ, Walser E, Vogt K. Delayed vs. Early Laparoscopic Appendectomy (DELAY) for Adult Patients with Acute Appendicitis: A randomized controlled trial. Ann Surg. 2023 Jul 13. doi: 10.1097/SLA.0000000000005996. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 Day Post Operative Complications		within 30 days of surgery
Secondary	Perforated Appendicitis		At time of surgery
Secondary	Operative Time		At time of surgery
Secondary	Length of Stay - Index Admission		Index Admission
Secondary	Length of Stay - Index admission plus any additional admissions within 30 days of surgery		30 Days