NCT04707339

Brief Summary

The Investigators aim to assess;

  1. 1.whether the changes in managing patients during COVID has reduced the negative appendicectomy rate?
  2. 2.compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis?
  3. 3.Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
  4. 4.Whether the incidence of complicated appendicitis has increased?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 30, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 11, 2021

Last Update Submit

January 12, 2021

Conditions

Keywords

Acute AppendicitisCOVID-19 pandemicManagement

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Length of Stay

    8 months

Study Arms (2)

Acute Appendicitis pre-COVID management

Audit of Acute appendicitis management in 2017-18

Procedure: Appendicectomy

Acute Appendicitis during COVID management

Audit of Acute appendicitis management in 2020

Procedure: Appendicectomy

Interventions

Laparoscopic or Open Appendicectomy

Acute Appendicitis during COVID managementAcute Appendicitis pre-COVID management

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a diagnosis of Acute Appendicitis will be included

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Princess Alexandra Hospital NHS Trust

Harlow, Essex, CM20 1EL, United Kingdom

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28932077BACKGROUND
  • 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.

    PMID: 29720238BACKGROUND
  • 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.

    PMID: 32615311BACKGROUND
  • 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.

    PMID: 32671661BACKGROUND
  • 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.

    PMID: 32200936BACKGROUND

MeSH Terms

Conditions

AppendicitisCOVID-19

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Naveed Kirmani, FRCS

    The Princess Alexandra Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeel A Dhahri, MRCS

CONTACT

Naveed Kirmani, FRCS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

January 30, 2020

Primary Completion

October 31, 2020

Study Completion

January 30, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations