Management of Acute Appendicitis at District General Hospital

Covid19 Clinical Trial

Official title:

Management of Acute Appendicitis at District General Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707339
• Other study ID #: 3810
• Status: Recruiting
• Start date: January 30, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2021
• Source: Princess Alexandra Hospital NHS Trust
• Contact: Adeel A Dhahri, MRCS
• Phone: +447936636920
• Email: adeelabbas.dhahri[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? 4. Whether the incidence of complicated appendicitis has increased?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute
• Covid19

Intervention

Procedure:
• Appendicectomy
Laparoscopic or Open Appendicectomy

Locations

Country	Name	City	State
United Kingdom	The Princess Alexandra Hospital NHS Trust	Harlow	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Princess Alexandra Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. Review. — View 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. 2020 Jul 15. doi: 10.1007/s10151-020-02297-4. [Epub ahead of print] Erratum in: Tech Coloproctol. 2020 Sep 25;:. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months
Primary	Outcomes of Conservative vs Operative Management	The outcomes of both conservatively and operatively managed patients will be assessed to define the best management approach.	8 months
Primary	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?	8 months
Primary	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	8 months
Secondary	Length of Stay	The number of days of postoperative admission in hospital will be assessed while comparing the type of surgery and co-morbidities.	8 months