Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05178251
Other study ID # 2021PI185
Secondary ID 2021PI185
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3
Completed NCT02265991 - Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A