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Completed

NCT Number: NCT05178251

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who underwent appendectomy

Exclusion criteria

  • pregnancy
  • protection of vulnerable adults
  • disability

Treatment and study plan

Appendectomy

Procedure

appendectomy for acute appendicitis

Primary outcomes

  1. Perioperative complications after appendectomy

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

    validated classification (Gomes classification)

  2. Postoperative complications after appendectomy

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

    validated classification (Clavien Dindo classification)

Secondary outcomes

  1. Delay before surgery

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

    Time duration from Symptoms onset and appendectomy

  2. Hospitalization duration

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

    Hospitalization duration

  3. Antibiotherapy duration

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

    Total antibiotherapy duration

  4. Biological inflammatory syndrom

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

    Hyperleucocytosis > 10000/mm3 and/or PCR > 100 mg/L

  5. Type of hospitalisation

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

    ward / ICU

  6. Delay between appedectomy and postoperative complications

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

    < 7 days; 7-30 days; > 30 days

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Centre Hospitalier Régional Metz-Thionville

Registry information

Acronym: SAP-19

Important dates

Study start
2018
Primary completion
2020
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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