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

NCT ID: NCT05178251

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-17
• Study Completion Date: 2024-10-01

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).

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

appendectomy

Intervention Type: PROCEDURE

appendectomy for acute appendicitis

Test group with Covid 19 pandemic

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

appendectomy

Intervention Type: PROCEDURE

appendectomy for acute appendicitis

Interventions

appendectomy

appendectomy for acute appendicitis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients who underwent appendectomy

Exclusion Criteria

• pregnancy
• protection of vulnerable adults
• disability

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Laurent BRUNAUD

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

laurent brunaud

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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

Nancy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 31797357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23047394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19638912 (View on PubMed)

Other Identifiers

2021PI185

Identifier Type: OTHER

Identifier Source: secondary_id

2021PI185

Identifier Type: -

Identifier Source: org_study_id