Clinical trial NCT04707339: Management of Acute Appendicitis at District General Hospital
Official title: Management of Acute Appendicitis at District General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appendicitis Acute
Covid19
Keywords: Acute Appendicitis
COVID-19 pandemic
Management
Lead sponsor: Princess Alexandra Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of Acute Appendicitis will be included

Brief 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. Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* None

Primary outcomes:
measure: Negative Appendicectomy Rate
timeFrame: 8 months
measure: Outcomes of Conservative vs Operative Management
timeFrame: 8 months
measure: Increased Open Appendicectomy Rate
timeFrame: 8 months
measure: Surgical site infection in patients on antibiotics
timeFrame: 8 months
Secondary outcomes:
measure: Length of Stay
timeFrame: 8 months
Other outcomes:
Locations:
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital NHS Trust
state: Essex
Study officials:
affiliation: The Princess Alexandra Hospital NHS Trust
name: Naveed Kirmani, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: van 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.
citation: Ferguson 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.
citation: Javanmard-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.
citation: RIFT 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.