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

November 14, 2023 updated by: Sunil Patel, Queen's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Kingston Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Appendectomy
Appendectomy is the surgical removal of the appendix.
Active Comparator: Immediate 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30 Day Post Operative Complications
Time Frame: within 30 days of surgery
within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Perforated Appendicitis
Time Frame: At time of surgery
At time of surgery
Operative Time
Time Frame: At time of surgery
At time of surgery
Length of Stay - Index Admission
Time Frame: Index Admission
Index Admission
Length of Stay - Index admission plus any additional admissions within 30 days of surgery
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2018

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURG-402-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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