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

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Appendectomy
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delayed Appendectomy

Immediate Appendectomy

Arm Description

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.

Patients will undergo appendectomy within 6 hours of the decision to operate. Surgery will take place between 2000 - 0400.

Outcomes

Primary Outcome Measures

30 Day Post Operative Complications

Secondary Outcome Measures

Perforated Appendicitis
Operative Time
Length of Stay - Index Admission
Length of Stay - Index admission plus any additional admissions within 30 days of surgery

Full Information

First Posted
May 2, 2018
Last Updated
September 13, 2021
Sponsor
Queen's University
Collaborators
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03524573
Brief Title
(D)Elayed vs. (E)Arly (L)Aparoscopic (A)Ppendectom(Y)
Acronym
DELAY
Official Title
Delayed vs. Early Laparoscopic Appendectomy : A Randomized Controlled Trial (The DELAY Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
London Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to the intervention.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Delayed Appendectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Immediate Appendectomy
Arm Type
Active Comparator
Arm Description
Patients will undergo appendectomy within 6 hours of the decision to operate. Surgery will take place between 2000 - 0400.
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Intervention Description
Appendectomy is the surgical removal of the appendix.
Primary Outcome Measure Information:
Title
30 Day Post Operative Complications
Time Frame
within 30 days of surgery
Secondary Outcome Measure Information:
Title
Perforated Appendicitis
Time Frame
At time of surgery
Title
Operative Time
Time Frame
At time of surgery
Title
Length of Stay - Index Admission
Time Frame
Index Admission
Title
Length of Stay - Index admission plus any additional admissions within 30 days of surgery
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil Patel, MD
Phone
613-549-6666
Email
Sunil.Patel@kingstonhsc.ca
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie E Taylor
Phone
613-544-3400
Ext
3320
Email
connie.taylor2@kingstonhsc.ca
First Name & Middle Initial & Last Name & Degree
Sunil V Patel, MD BSc
Phone
613-548-3232
Ext
7995
Email
Sunil.Patel@kingstonhsc.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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