ClinicalTrials.gg
CompletedNCT05178251SAP-19Updated Feb 13, 2025

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

An observational study in Postoperative Complications, Appendicitis and COVID-19 Pandemic, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

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

Keywords

  • appendectomy
  • postoperative complications
  • covid 19
03

In context

Postoperative Complications

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's enrollment of 300 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who underwent appendectomy

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • protection of vulnerable adults
  • disability
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedureappendectomy

    appendectomy for acute appendicitis

06

What researchers measure

Primary outcomes

  1. Perioperative complications after appendectomy

    validated classification (Gomes classification)

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

  2. Postoperative complications after appendectomy

    validated classification (Clavien Dindo classification)

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

Secondary outcomes

  1. Delay before surgery

    Time duration from Symptoms onset and appendectomy

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

  2. Hospitalization duration

    Hospitalization duration

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

  3. Antibiotherapy duration

    Total antibiotherapy duration

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

  4. Biological inflammatory syndrom

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

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

  5. Type of hospitalisation

    ward / ICU

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

  6. Delay between appedectomy and postoperative complications

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

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

07

Study locations

1 site
  • CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)
    Nancy, 54511, France
08

References and documents

Publications

  • 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. PubMed 31797357 ↗
  • 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. PubMed 23047394 ↗
  • 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. PubMed 19638912 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05178251
Responsible party
Laurent BRUNAUD (Professor of Surgery, Central Hospital, Nancy, France) — Principal investigator
First posted
Jan 5, 2022
Start date
Mar 17, 2018
Primary completion
Dec 14, 2020
Completion
Oct 1, 2024
Last update
Feb 13, 2025

Study contacts

laurent brunaud
principal investigator · CHRU Nancy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion