Trial Outcomes & Findings for Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients (NCT NCT04748120)

NCT ID: NCT04748120

Last Updated: 2022-03-14

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 90 days
• Results posted on: 2022-03-14

Participant Flow

Participant milestones

Measure	Operative Management Treatment with surgery Operative management: 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.	Non-operative Management Treatment with antibiotics Non-operative management: 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.	Total n=2 Participants Total of all reporting groups
Age, Continuous	32 Years n=1 Participants	72 Years n=1 Participants	52 Years n=2 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	1 participants n=1 Participants	2 participants n=2 Participants

PRIMARY outcome

Timeframe: Up to 90 days

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

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.
Number of Participants With Pulmonary Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 90 days

ICU admission following randomization

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.
Number of Participants With Post-intervention ICU Admission	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Any death

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.
Mortality (All Cause)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Population: Subject in the Operative management did not develop any complications that met Clavien-Dindo classification

The Clavien-Dindo classification is a grading scale from 1 to 5 (with 5 being more severe0 to objectively describe the severity of a complication, including any deviation from the normal postoperative course

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management Treatment with antibiotics Non-operative management: 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.
Complications as Measured by the Clavien-Dindo Classification	1 score on a scale	—

SECONDARY outcome

Timeframe: Up to 90 days

Cumulative and individual length of hospitalization(s)

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.
Median Length of Hospital Stay	44 Hours	137 Hours

SECONDARY outcome

Timeframe: Up to 90 days

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management n=1 Participants Treatment with antibiotics Non-operative management: 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.
Number of Emergency Room Visits/Readmission	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90 days

Patients randomized to non-operative management who require non-elective surgery to remove the affected organ

Outcome measures

Measure	Operative Management n=1 Participants Treatment with surgery Operative management: 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.	Non-operative Management Treatment with antibiotics Non-operative management: 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.
Number of Participants With Treatment Failure for Non-operative Management	0 Participants	—

Adverse Events

Operative Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-operative Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Clayton Petro

Cleveland Clinic Foundation

Phone: 216-444-3501

Email: petroc@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place