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

Learn more about:
Related Clinical Trial
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. Naldebain for Pain Management of Laparoscopic Cholecystectomy Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis Safety and Feasibility of ActivSightTM in Human Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study. A Scoring System for Difficult Laparoscopic Cholecystectomy RISK FACTORS FOR NECROTIC CHOLECYSTITIS DURING COVID-19 PANDEMIC: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

Brief Title

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

Official Title

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

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.
    

Detailed Description

      As the novel coronavirus disease 2019 (COVID-19) disseminates across the United States, more
      routine preoperative testing is going to expose infected patients with no or mild pneumonia
      symptoms. Currently, little is known regarding the true consequences of general anesthesia in
      COVID-positive (COVID+) patients. Surgeons are going to face challenging decisions regarding
      whether or not to operate for non-elective cases requiring general anesthesia when
      non-operative treatment options exist. Patients with acute appendicitis are usually treated
      with an operation to remove the appendix, but they can also be initially treated with
      antibiotics and have an operation at a later date. Similarly, patients with acute
      cholecystitis are usually treated with an operation to remove the gallbladder, but they can
      be treated with antibiotics and a percutaneous cholecystostomy tube (a tube that going
      through the skin to drain the gallbladder) and have an operation at a later date. However,
      patients managed without a definitive operation may require more resource utilization, PPE
      consumption, interactions with hospital personnel, and could experience treatment failures
      that exacerbate their viral illness. This is a pilot study comparing the safety of operative
      versus non-operative management of COVID+ patients with mild to moderate symptoms.
    


Study Type

Interventional


Primary Outcome

Rate of pulmonary complications

Secondary Outcome

 Rate of post-intervention ICU admission

Condition

Covid19

Intervention

Operative management

Study Arms / Comparison Groups

 Operative management
Description:  Treatment with surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

December 28, 2020

Completion Date

September 28, 2021

Primary Completion Date

June 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  COVID-19 confirmed positive by a microbiologic test.

          -  Mild COVID-19 - no or mild pneumonia

          -  EITHER

               1. Uncomplicated acute appendicitis without a fecalith OR

               2. 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.

               1. Murphy's sign

               2. RUQ mass/pain/tenderness B. Systemic signs of inflammation etc.

               1. Fever

               2. elevated CRP

               3. elevated WBC count C. Imaging findings characteristic of acute cholecystitis

        Exclusion Criteria:

          -  Active pregnancy

          -  COVID-19 severe disease that would be a contraindication to operative intervention at
             the discretion of the attending surgeon supported by the following, none of which are
             individually required or are a strict exclusion criterion as some of these could be
             attributed or exacerbated by the underlying surgical problem:

               1. Persistent dyspnea

               2. Persistent respiratory frequency >30/min

               3. Persistent blood oxygen saturation <93%

               4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300

               5. 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clayton C Petro, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04748120

Organization ID

20-525


Responsible Party

Principal Investigator

Study Sponsor

The Cleveland Clinic


Study Sponsor

Clayton C Petro, MD, Principal Investigator, Associate Professor of Surgery


Verification Date

February 2021