Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients

NCT04748120 | Terminated Results DMC

• 1 other identifier: 20-525
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.

Conditions

Covid19; Appendicitis; Cholecystitis, Acute; Cholecystitis; Gallstone; Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pulmonary Complications

  Including pneumonia, acute respiratory distress syndrome (ARDS) or unexpected postoperative ventilation For operative management this means any episode of non-invasive ventilation, invasive ventilation, or extracorporeal membrane oxygenation after initial extubation after surgery, or patient cannot be extubated as planned after surgery. For non-operative management this means any intubation

  Up to 90 days

Secondary Outcomes (5)

• Number of Participants With Post-intervention ICU Admission

  Up to 90 days

• Mortality (All Cause)

  Up to 90 days

• Complications as Measured by the Clavien-Dindo Classification

  Up to 90 days

• Median Length of Hospital Stay

  Up to 90 days

• Number of Emergency Room Visits/Readmission

  Up to 90 days

Other Outcomes (1)

• Number of Participants With Treatment Failure for Non-operative Management

  Up to 90 days

Study Arms (2)

Operative management

ACTIVE COMPARATOR

Treatment with surgery

Procedure: Operative management

Non-operative management

ACTIVE COMPARATOR

Treatment with antibiotics

Procedure: Non-operative management

Interventions

Operative management PROCEDURE

Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.

Operative management

Non-operative management PROCEDURE

Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below: Non-penicillin allergic patients * piperacillin/tazobactam 3.375g IV every 6 hours for 3 days * amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days Penicillin allergic patients * ertapenem 1g IV every 24 hours for 3 days * ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis.

Non-operative management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 confirmed positive by a microbiologic test.
• Mild COVID-19 - no or mild pneumonia
• EITHER
• Uncomplicated acute appendicitis without a fecalith OR
• Acute cholecystitis - by TG18/TG13 diagnostic criteria where definite diagnosis requires one item in A + one item in B + C A. Local signs of inflammation etc.
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• Murphy's sign
• RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.
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• Fever
• elevated CRP
• elevated WBC count C. Imaging findings characteristic of acute cholecystitis

You may not qualify if:

• Active pregnancy
• Persistent dyspnea
• Persistent respiratory frequency \>30/min
• Persistent blood oxygen saturation \<93%
• Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300
• Lung infiltrates \>50%
• COVID-19 critical disease - respiratory failure, shock, or multiorgan dysfunction
• The surgeon expects increased operative complexity - high risk of conversion to open or prolonged procedure
• Unable or unwilling to consent or fulfill study procedures - need to complete 90 day follow-up by telephone

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (7)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.

  PMID: 32292899 BACKGROUND

• Aminian A, Safari S, Razeghian-Jahromi A, Ghorbani M, Delaney CP. COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period. Ann Surg. 2020 Jul;272(1):e27-e29. doi: 10.1097/SLA.0000000000003925.

  PMID: 32221117 BACKGROUND

• Podda M, Gerardi C, Cillara N, Fearnhead N, Gomes CA, Birindelli A, Mulliri A, Davies RJ, Di Saverio S. Antibiotic Treatment and Appendectomy for Uncomplicated Acute Appendicitis in Adults and Children: A Systematic Review and Meta-analysis. Ann Surg. 2019 Dec;270(6):1028-1040. doi: 10.1097/SLA.0000000000003225.

  PMID: 30720508 BACKGROUND

• Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, Ukai T, Endo I, Iwashita Y, Hibi T, Pitt HA, Matsunaga N, Takamori Y, Umezawa A, Asai K, Suzuki K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibanes E, Shikata S, Noguchi Y, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):3-16. doi: 10.1002/jhbp.518. Epub 2018 Jan 9.

  PMID: 29090866 BACKGROUND

• Davis CA, Landercasper J, Gundersen LH, Lambert PJ. Effective use of percutaneous cholecystostomy in high-risk surgical patients: techniques, tube management, and results. Arch Surg. 1999 Jul;134(7):727-31; discussion 731-2. doi: 10.1001/archsurg.134.7.727.

  PMID: 10401823 BACKGROUND

• Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.

  PMID: 29032636 BACKGROUND

MeSH Terms

Conditions

COVID-19; Appendicitis; Cholecystitis, Acute; Cholecystitis; Gallstones

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Intraabdominal Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Clayton Petro
• Organization: Cleveland Clinic Foundation

petroc@ccf.org

216-444-3501

Study Officials

• Clayton C Petro, MD

  Associate Professor of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be informed regarding the treatment they receive at the time of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a prospective, non-blinded, pilot randomized controlled trial comparing operative to non-operative management of acute appendicitis and acute cholecystitis in patients with mild to moderate COVID-19 infection. This will be a two-arm trial with intervention 1: intervention 2 allocation ratio of 1:1.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: December 28, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: March 14, 2022
• Results First Posted: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)