COVID 19: Is SARS-CoV-2 Contaminating Surgical Aerosols From Laparoscopy and Open Abdominal Surgery?

NCT04444687 | Withdrawn

• 1 other identifier: 052020
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims at answering the question if aerosols from laparoscopic or open abdominal surgery contain SARS-CoV-2 virus and need to be considered contagious.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• SARS-COV-2 RNA detection

  The primary outcome will be SARS-COV-2 RNA detection in filter systems for surgical aerosols in laparoscopic surgery (YES/NO). If viral RNA can be detected, the aerosols should be considered contagious, and therefore the debate on protective measures for the surgical staff in case of emergency surgery and possibly delaying any urgent surgery to protect surgical teams would be reasonable. If viral RNA cannot be detected, the aerosols do not need to be considered contagious for SARS-CoV-2, and CoVID-19 patients could safely be considered for laparoscopic and open abdominal surgery if indicated.

  Up to 12 months

Secondary Outcomes (3)

• Viral contamination of peritoneal cavity and fluid

  Up to 12 months

• Viral contamination of peritoneal cavity and fluid in open cases

  Up to 12 months

• Viral infection of members of the surgical team

  Up to 12 months

Study Arms (4)

SARS-CoV-2-positive 01

SARS-CoV-2-positive patient, no symptoms, low viral load in tracheal aspirate, RNAemia not detectable

Diagnostic Test: Test for SARS-CoV-2

SARS-CoV-2-positive 02

SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia not detectable

Diagnostic Test: Test for SARS-CoV-2

SARS-CoV-2-positive 03

SARS-CoV-2-positive patient, symptoms, high viral load in tracheal aspirate, RNAemia detectable

Diagnostic Test: Test for SARS-CoV-2

Control

Control patients, SARS-CoV-2-negative

Diagnostic Test: Test for SARS-CoV-2

Interventions

Test for SARS-CoV-2 DIAGNOSTIC_TEST

* As part of normal emergency evaluation due to symptoms or following standard operation procedure for patients heading to the operating theatre the status for SARS-CoV-2 is evaluated (gene expert, Roche) * After intubation samples are acquired in the OR 1. tracheal aspirate specimen directly after intubation (as part of standard operation procedures for CoVID-19 patients) 2. blood sample (as part of standard operation procedures for CoVID-19 patients) 3. fluid sample and smears from abdominal cavity as soon as this is accessed either by laparoscopy or laparotomy 4. Sample from laparoscopic smoke filters (Laparoshield™ Laparoscopic Smoke Filtration System) * Fluid samples and smears are frozen at -80 degrees celcius for conservation in the OR.

Control; SARS-CoV-2-positive 01; SARS-CoV-2-positive 02; SARS-CoV-2-positive 03

Eligibility Criteria

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

Study Population

Inhabitants of the area around Basel/North west Switzerland

You may qualify if:

• Age ≥ 18 years
• Proven or suspected (not ruled out) SARS-CoV-2 infection (at the time of surgery)
• Undergoing urgent or emergency laparoscopic or open abdominal surgery
• Able to provide informed general consent on further use of clinical data

You may not qualify if:

• Age \< 18 years
• Unable to provide informed general consent \& no possibility of informed general consent by proxy
• Recent (\<24h) negative test for SARS-CoV-2

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Biospecimen

Retention: SAMPLES WITH DNA

Tracheal aspirate, blood sample, fluid sample/smears from abdominal cavity, Sample from laparoscopic smoke filters

Study Officials

• Marco von Strauss und Torney

  Clarunis University Centre for Gastrointestinal and Liver Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 23, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share