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

Postoperative Complications Clinical Trial

— SAP-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05178251
• Other study ID #: 2021PI185
• Secondary ID: 2021PI185
• Status: Active, not recruiting
• Start date: March 17, 2018
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who underwent appendectomy

Exclusion Criteria:

• pregnancy

• protection of vulnerable adults

• disability

Related Conditions & MeSH terms

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

Intervention

Procedure:
• appendectomy
appendectomy for acute appendicitis

Locations

Country	Name	City	State
France	CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

References & 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. Review. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative complications after appendectomy	validated classification (Gomes classification)	from March 17 to December 14 (2020-2021 versus 2019-2018)
Primary	Postoperative complications after appendectomy	validated classification (Clavien Dindo classification)	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Delay before surgery	Time duration from Symptoms onset and appendectomy	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Hospitalization duration	Hospitalization duration	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Antibiotherapy duration	Total antibiotherapy duration	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Biological inflammatory syndrom	Hyperleucocytosis > 10000/mm3 and/or PCR > 100 mg/L	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Type of hospitalisation	ward / ICU	from March 17 to December 14 (2020-2021 versus 2019-2018)
Secondary	Delay between appedectomy and postoperative complications	< 7 days; 7-30 days; > 30 days	from March 17 to December 14 (2020-2021 versus 2019-2018)