Impact of SARS-Cov2 Pandemic on Severity of Perioperative Complications in Patients Undergoing Appendectomy

NCT05178251 | Completed DMC

• 1 other identifier: 2021PI185
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

There are 2 types of surgical procedures to remove the appendix : open appendectomy or laparoscopic appendectomy. About 60000 appendectomies are performed every year in France. Early diagnosis of acute appendicitis is essential to prevent the risk of disease progression, leading to complicated appendicitis and an increased risk for mortality. Data regarding appendicitis management in the literature are numerous. However, the impact of COVID-19 pandemic on the management of those patients has led to a decrease in the number of visits for acute appendicitis (ER), but a higher proportion of complicated appendicitis, probably due to the patient's delayed decision to go to emergency department at the onset of clinical symptoms. Complicated appendicitis may also lead to an overuse of antibiotics, a longer hospital stay, and a higher global cost for the health system. This aim of this study was to evaluate whether this hypothesis was valid for the regional NANCY-METZ area (CHR Metz and CHRU Nancy). The main research hypothesis was that the pandemic caused by SARS-COVID 19 was significantly linked to an increased incidence of perioperative complications in patients who underwent an appendectomy for acute appendicitis in this region (North-east part of France).

Conditions

Postoperative Complications; Appendicitis; COVID-19 Pandemic; Appendicitis With Peritonitis

Keywords

appendectomy; postoperative complications; covid 19

Outcome Measures

Primary Outcomes (2)

• Perioperative complications after appendectomy

  validated classification (Gomes classification)

  from March 17 to December 14 (2020-2021 versus 2019-2018)

• Postoperative complications after appendectomy

  validated classification (Clavien Dindo classification)

  from March 17 to December 14 (2020-2021 versus 2019-2018)

Secondary Outcomes (6)

• Delay before surgery

  from March 17 to December 14 (2020-2021 versus 2019-2018)

• Hospitalization duration

  from March 17 to December 14 (2020-2021 versus 2019-2018)

• Antibiotherapy duration

  from March 17 to December 14 (2020-2021 versus 2019-2018)

• Biological inflammatory syndrom

  from March 17 to December 14 (2020-2021 versus 2019-2018)

• Type of hospitalisation

  from March 17 to December 14 (2020-2021 versus 2019-2018)

Study Arms (2)

Control group without Covid 19 pandemic

\- Patients who underwent an appendectomy from March 17, 2018 to December 14, 2018 and from March 17, 2019 to December 14, 2019

Procedure: appendectomy

Test group with Covid 19 pandemic

\- Patients who underwent an appendectomy from March 17, 2020 to December 14, 2020

Procedure: appendectomy

Interventions

appendectomy PROCEDURE

appendectomy for acute appendicitis

Control group without Covid 19 pandemic; Test group with Covid 19 pandemic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients managed at : * CHR Mercy * CHRU nancy and who underwent appendectomy during the study period

You may qualify if:

• patients who underwent appendectomy

You may not qualify if:

• pregnancy
• protection of vulnerable adults
• disability

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Centre Hospitalier Régional Metz-Thionville: collaborator

Study Sites (1)

CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Nancy, 54511, France

Location

Related Publications (3)

• Bhangu A; RIFT Study Group on behalf of the West Midlands Research Collaborative. Evaluation of appendicitis risk prediction models in adults with suspected appendicitis. Br J Surg. 2020 Jan;107(1):73-86. doi: 10.1002/bjs.11440. Epub 2019 Dec 3.

  PMID: 31797357 BACKGROUND

• Gomes CA, Nunes TA, Fonseca Chebli JM, Junior CS, Gomes CC. Laparoscopy grading system of acute appendicitis: new insight for future trials. Surg Laparosc Endosc Percutan Tech. 2012 Oct;22(5):463-6. doi: 10.1097/SLE.0b013e318262edf1.

  PMID: 23047394 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Appendicitis; COVID-19

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• laurent brunaud

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 5, 2022
• Study Start: March 17, 2018
• Primary Completion: December 14, 2020
• Study Completion: October 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)