Appendicitis AcuteNCT04707339
Management of Acute Appendicitis at District General Hospital
An observational study of Appendicitis Acute and Covid19, run by Princess Alexandra Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The Investigators aim to assess; 1. whether the changes in managing patients during COVID has reduced the negative appendicectomy rate? 2. compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis? 3. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Appendicitis Acute, Covid19
- What is being tested?
- Appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2020to 30 Jan 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients with a diagnosis of Acute Appendicitis will be included
Who may be able to join
- All participants reporting in accident and emergency with a diagnosis of acute appendicitis irrespective of age above 5 years, gender and morbidities (this group for conservative management)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Princess Alexandra Hospital NHS Trust
Harlow, Essex, CM20 1EL
Adeel A Dhahri, MRCS, 07936636920, adeelabbas.dhahri@nhs.net
Naveed Kirmani, FRCS, 01279444455, naveed.kirmani@nhs.net
About this study
The Investigators aim to assess;
- whether the changes in managing patients during COVID has reduced the negative appendicectomy rate?
- compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis?
- Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
- Whether the incidence of complicated appendicitis has increased?
Read the detailed description
As acute appendicitis is the most commonly managed emergency presentation for surgeons, the investigators aim to assess whether the changes in managing patients during COVID has reduced the negative appendicectomy rate, to compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis? to assess whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? to assess whether the incidence of complicated appendicitis has increased? This will be a single centre retrospective observational study. All the patients presenting in A\&E department with a diagnosis of acute appendicitis to be included. the only exclusion criteria are the age of participants for less than 5 years. The data will be analysed and calculated using SPSS version 23.
- Conditions
- Appendicitis Acute, Covid19
- Being tested
- Appendicectomy
- Keywords
- Acute Appendicitis, COVID-19 pandemic, Management
- Medical subject headings
- Appendicitis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendicectomyProcedure or surgery
Laparoscopic or Open Appendicectomy
| Study group | Role | What they receive |
|---|---|---|
| Acute Appendicitis pre-COVID management | Audit of Acute appendicitis management in 2017-18 Receives: Procedure: Appendicectomy | |
| Acute Appendicitis during COVID management | Audit of Acute appendicitis management in 2020 Receives: Procedure: Appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Appendicectomy Rate
Negative appendicectomy rate will be calculated to define the benefits of increasing the preoperative scanning in the form of ultrasound, CT scan or both.
Measured: 8 months
Outcomes of Conservative vs Operative Management
The outcomes of both conservatively and operatively managed patients will be assessed to define the best management approach.
Measured: 8 months
Increased Open Appendicectomy Rate
The rate of laparoscopic to open and open appendicectomy rate will be calculated to understand if the surgical practice has been changed during COVID-19 pandemic?
Measured: 8 months
Surgical site infection in patients on antibiotics
The rate of incidence of superficial and deep wound infection will be calculated to define the applicability of use of Antibiotics
Measured: 8 months
Secondary outcomes (1)
Length of Stay
The number of days of postoperative admission in hospital will be assessed while comparing the type of surgery and co-morbidities.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start30 Jan 2020
- Primary completion31 Oct 2020
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Alexandra Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveed Kirmani, Princess Alexandra Hospital NHS Trust
- Investigators
- Naveed Kirmani, FRCS, Principal investigator, The Princess Alexandra Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707339
- Sponsor's protocol ID
- 3810
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hori T, Machimoto T, Kadokawa Y, Hata T, Ito T, Kato S, Yasukawa D, Aisu Y, Kimura Y, Sasaki M, Takamatsu Y, Kitano T, Hisamori S, Yoshimura T. Laparoscopic appendectomy for acute appendicitis: How to discourage surgeons using inadequate therapy. World J Gastroenterol. 2017 Aug 28;23(32):5849-5859. doi: 10.3748/wjg.v23.i32.5849.
PubMed 28932077van den Boom AL, de Wijkerslooth EML, van Rosmalen J, Beverdam FH, Boerma EG, Boermeester MA, Bosmans JWAM, Burghgraef TA, Consten ECJ, Dawson I, Dekker JWT, Emous M, van Geloven AAW, Go PMNYH, Heijnen LA, Huisman SA, Jean Pierre D, de Jonge J, Kloeze JH, Koopmanschap MA, Langeveld HR, Luyer MDP, Melles DC, Mouton JW, van der Ploeg APT, Poelmann FB, Ponten JEH, van Rossem CC, Schreurs WH, Shapiro J, Steenvoorde P, Toorenvliet BR, Verhelst J, Versteegh HP, Wijnen RMH, Wijnhoven BPL. Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):263. doi: 10.1186/s13063-018-2629-0.
PubMed 29720238Ferguson DM, Parker TD, Arshad SA, Garcia EI, Hebballi NB, Tsao K. Standardized Discharge Antibiotics May Reduce Readmissions in Pediatric Perforated Appendicitis. J Surg Res. 2020 Nov;255:388-395. doi: 10.1016/j.jss.2020.05.086. Epub 2020 Jun 29.
PubMed 32615311Javanmard-Emamghissi H, Boyd-Carson H, Hollyman M, Doleman B, Adiamah A, Lund JN, Clifford R, Dickerson L, Richards S, Pearce L, Cornish J, Hare S, Lockwood S, Moug SJ, Tierney GM; COVID: HAREM (Had Appendicitis, Resolved/Recurred Emergency Morbidity/Mortality) Collaborators Group. The management of adult appendicitis during the COVID-19 pandemic: an interim analysis of a UK cohort study. Tech Coloproctol. 2021 Apr;25(4):401-411. doi: 10.1007/s10151-020-02297-4. Epub 2020 Jul 15.
PubMed 32671661RIFT Study Group on behalf of the West Midlands Research Collaborative. Appendicitis risk prediction models in children presenting with right iliac fossa pain (RIFT study): a prospective, multicentre validation study. Lancet Child Adolesc Health. 2020 Apr;4(4):271-280. doi: 10.1016/S2352-4642(20)30006-7. Epub 2020 Feb 13.
PubMed 32200936
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Appendicitis at District General Hospital
- ClinicalTrials.gov ID
- NCT04707339
- Acronym / sponsor ID
- 3810
- Conditions
- Appendicitis Acute, Covid19
- Keywords
- Acute Appendicitis, COVID-19 pandemic, Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Princess Alexandra Hospital NHS TrustUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 13 Jan 2021 (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 Investigators aim to assess;
- whether the changes in managing patients during COVID has reduced the negative appendicectomy rate?
- compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis?
- Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
- Whether the incidence of complicated appendicitis has increased?
Detailed description
As acute appendicitis is the most commonly managed emergency presentation for surgeons, the investigators aim to assess whether the changes in managing patients during COVID has reduced the negative appendicectomy rate, to compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis? to assess whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? to assess whether the incidence of complicated appendicitis has increased? This will be a single centre retrospective observational study. All the patients presenting in A\&E department with a diagnosis of acute appendicitis to be included. the only exclusion criteria are the age of participants for less than 5 years. The data will be analysed and calculated using SPSS version 23.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Appendicitis pre-COVID management | – | Procedure: AppendicectomyAudit of Acute appendicitis management in 2017-18 |
| Acute Appendicitis during COVID management | – | Procedure: AppendicectomyAudit of Acute appendicitis management in 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a diagnosis of Acute Appendicitis will be included
Key inclusion criteria (1 listed)
- All participants reporting in accident and emergency with a diagnosis of acute appendicitis irrespective of age above 5 years, gender and morbidities (this group for conservative management)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AppendicectomyLaparoscopic or Open Appendicectomy | Procedure or surgery | Acute Appendicitis during COVID management, Acute Appendicitis pre-COVID management |
Primary outcome
Negative Appendicectomy Rate
Time frame: 8 months
Negative appendicectomy rate will be calculated to define the benefits of increasing the preoperative scanning in the form of ultrasound, CT scan or both.
Outcomes of Conservative vs Operative Management
Time frame: 8 months
The outcomes of both conservatively and operatively managed patients will be assessed to define the best management approach.
Increased Open Appendicectomy Rate
Time frame: 8 months
The rate of laparoscopic to open and open appendicectomy rate will be calculated to understand if the surgical practice has been changed during COVID-19 pandemic?
Surgical site infection in patients on antibiotics
Time frame: 8 months
The rate of incidence of superficial and deep wound infection will be calculated to define the applicability of use of Antibiotics
1 secondary outcome
Length of Stay
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 28932077Hori T, Machimoto T, Kadokawa Y, Hata T, Ito T, Kato S, Yasukawa D, Aisu Y, Kimura Y, Sasaki M, Takamatsu Y, Kitano T, Hisamori S, Yoshimura T. Laparoscopic appendectomy for acute appendicitis: How to discourage surgeons using inadequate therapy. World J Gastroenterol. 2017 Aug 28;23(32):5849-5859. doi: 10.3748/wjg.v23.i32.5849.
- Background: PubMed 29720238van den Boom AL, de Wijkerslooth EML, van Rosmalen J, Beverdam FH, Boerma EG, Boermeester MA, Bosmans JWAM, Burghgraef TA, Consten ECJ, Dawson I, Dekker JWT, Emous M, van Geloven AAW, Go PMNYH, Heijnen LA, Huisman SA, Jean Pierre D, de Jonge J, Kloeze JH, Koopmanschap MA, Langeveld HR, Luyer MDP, Melles DC, Mouton JW, van der Ploeg APT, Poelmann FB, Ponten JEH, van Rossem CC, Schreurs WH, Shapiro J, Steenvoorde P, Toorenvliet BR, Verhelst J, Versteegh HP, Wijnen RMH, Wijnhoven BPL. Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):263. doi: 10.1186/s13063-018-2629-0.
- Background: PubMed 32615311Ferguson DM, Parker TD, Arshad SA, Garcia EI, Hebballi NB, Tsao K. Standardized Discharge Antibiotics May Reduce Readmissions in Pediatric Perforated Appendicitis. J Surg Res. 2020 Nov;255:388-395. doi: 10.1016/j.jss.2020.05.086. Epub 2020 Jun 29.
- Background: PubMed 32671661Javanmard-Emamghissi H, Boyd-Carson H, Hollyman M, Doleman B, Adiamah A, Lund JN, Clifford R, Dickerson L, Richards S, Pearce L, Cornish J, Hare S, Lockwood S, Moug SJ, Tierney GM; COVID: HAREM (Had Appendicitis, Resolved/Recurred Emergency Morbidity/Mortality) Collaborators Group. The management of adult appendicitis during the COVID-19 pandemic: an interim analysis of a UK cohort study. Tech Coloproctol. 2021 Apr;25(4):401-411. doi: 10.1007/s10151-020-02297-4. Epub 2020 Jul 15.
- Background: PubMed 32200936RIFT Study Group on behalf of the West Midlands Research Collaborative. Appendicitis risk prediction models in children presenting with right iliac fossa pain (RIFT study): a prospective, multicentre validation study. Lancet Child Adolesc Health. 2020 Apr;4(4):271-280. doi: 10.1016/S2352-4642(20)30006-7. Epub 2020 Feb 13.
- Individual participant dataSharing planned: No
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
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.
Naveed Kirmani, FRCS principal investigator
The Princess Alexandra Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute and Covid19, run by Princess Alexandra Hospital NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeel A Dhahri, MRCS (+447936636920, adeelabbas.dhahri@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Appendicectomy Rate (time frame: 8 months). The study lists 4 primary outcomes in all. 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 NCT04707339, which also lists 5 linked publications.
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 14 Jan 2021.