AppendicitisDELAYNCT03524573
(D)Elayed vs. (E)Arly (L)Aparoscopic (A)Ppendectom(Y)
A study testing Appendectomy in people with Appendicitis, run by Queen's University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2018to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Appendicitis
- Being tested
- Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Appendectomy is the surgical removal of the appendix.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day Post Operative Complications
Measured: within 30 days of surgery
Secondary outcomes (4)
Perforated Appendicitis
Measured: At time of surgery
Operative Time
Measured: At time of surgery
Length of Stay - Index Admission
Measured: Index Admission
Length of Stay - Index admission plus any additional admissions within 30 days of surgery
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start5 Nov 2018
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Principal investigator, Sunil Patel, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524573
- Sponsor's protocol ID
- SURG-402-17
- Acronym
- DELAY
- Status last verified
- Nov 2023
- First submitted
- 2 May 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37436871
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed vs. Early Laparoscopic Appendectomy : A Randomized Controlled Trial (The DELAY Trial)
- ClinicalTrials.gov ID
- NCT03524573
- Acronym / sponsor ID
- DELAY / SURG-402-17
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Delayed Appendectomy | Experimental | Procedure: AppendectomyPatients 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. |
| Immediate Appendectomy | Active comparator | Procedure: AppendectomyPatients will undergo appendectomy within 6 hours of the decision to operate. Surgery will take place between 2000 - 0400. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with hemodynamic instability
- Patients with suspected sepsis
- Unknown diagnosis
- Presence of abscess on CT Scan
- Diagnosis of missed appendicitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomyAppendectomy is the surgical removal of the appendix. | Procedure or surgery | Delayed Appendectomy, Immediate Appendectomy |
Primary outcome
30 Day Post Operative Complications
Time frame: within 30 days of surgery
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 37436871Patel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy in people with Appendicitis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day Post Operative Complications (time frame: within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.