Impact of SARS-Cov2 Pandemic on Severity of Perioperative Complications in Patients Undergoing Appendectomy (SAP-19)

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Appendicitis; COVID-19 Pandemic; Appendicitis With Peritonitis
• Intervention / Treatment: Procedure: appendectomy

Detailed Description

Appendix is a finger-like, blind-ended tube connected to the cecum. The most frequent disease regarding the appendix is appendicitis. Appendicitis is an inflammation of the appendix caused by an obstruction of the lumen of the appendix. This obstruction is most commonly due to an appendicolith (calcified "stone" made of feces). Inflamed lymphoid tissue from a viral infection, parasites, gallstone, or tumors may also cause the blockage. This blockage leads to an increased pressure in the appendix, leading to a decreased blood flow to the tissues of the appendix, and bacterial growth inside the appendix causing inflammation. The combination of inflammation, reduced blood flow to the appendix and distention of the appendix causes tissue injury and lead to infection and potentially necrosis. If this process is left untreated, the appendix may burst, releasing bacteria into the abdominal cavity, leading to a peritonitis with a potential impact on mortality rate. Appendicitis symptoms include right lower abdominal pain, nausea, vomiting, and decreased appetite. Complicated appendicitis is defined as perforated appendicitis, peri-appendicular abscess or peritonitis. Consequently, acute appendicitis is considered to be a surgical emergency.

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).

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54511
    • CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients managed at :

• CHR Mercy
• CHRU nancy

and who underwent appendectomy during the study period

Description

Inclusion Criteria:

• patients who underwent appendectomy

Exclusion Criteria:

• pregnancy
• protection of vulnerable adults
• disability

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; appendectomy for acute appendicitis
Test group with Covid 19 pandemic; - Patients who underwent an appendectomy from March 17, 2020 to December 14, 2020	Procedure: appendectomy; appendectomy for acute appendicitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay before surgery	Time duration from Symptoms onset and appendectomy	from March 17 to December 14 (2020-2021 versus 2019-2018)
Hospitalization duration	Hospitalization duration	from March 17 to December 14 (2020-2021 versus 2019-2018)
Antibiotherapy duration	Total antibiotherapy duration	from March 17 to December 14 (2020-2021 versus 2019-2018)
Biological inflammatory syndrom	Hyperleucocytosis > 10000/mm3 and/or PCR > 100 mg/L	from March 17 to December 14 (2020-2021 versus 2019-2018)
Type of hospitalisation	ward / ICU	from March 17 to December 14 (2020-2021 versus 2019-2018)
Delay between appedectomy and postoperative complications	< 7 days; 7-30 days; > 30 days	from March 17 to December 14 (2020-2021 versus 2019-2018)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: laurent brunaud, Chru Nancy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2018
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: covid 19; postoperative complications; appendectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Gastroenteritis; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Peritoneal Diseases; Cecal Diseases; Intraabdominal Infections; COVID-19; Postoperative Complications; Appendicitis; Peritonitis
• Other Study ID Numbers: 2021PI185 (Other Identifier: DRCI CHRU Nancy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No