NCT03524573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.4 years

First QC Date

May 2, 2018

Last Update Submit

November 14, 2023

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • 30 Day Post Operative Complications

    within 30 days of surgery

Secondary Outcomes (4)

  • Perforated Appendicitis

    At time of surgery

  • Operative Time

    At time of surgery

  • Length of Stay - Index Admission

    Index Admission

  • Length of Stay - Index admission plus any additional admissions within 30 days of surgery

    30 Days

Study Arms (2)

Delayed Appendectomy

EXPERIMENTAL

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

Immediate Appendectomy

ACTIVE COMPARATOR

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

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

Appendectomy is the surgical removal of the appendix.

Delayed AppendectomyImmediate Appendectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37436871BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 15, 2018

Study Start

November 5, 2018

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

CA(1)