Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)
Condition: Procedure Time
Study type: Interventional

Summary: 
      The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a
      significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating
      procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to
      20 minutes, between patients, to reduce medical risk exposure. Planning strategies to
      facilitate economic reactivation of endoscopy services in a responsible manner, maintaining
      adequate security measures for both patients and healthcare personnel is currently a major
      challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and
      colonoscopy are commonly performed during the same sedation time. Estimated times for quality
      inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In
      addition, time to reach the cecum and to set up the following procedure increase not only
      procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two
      procedures simultaneously by two endoscopists would considerably reduce procedure time while
      increasing the number of patients evaluated in one day, especially in the period of service
      reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and,
      serial procedures. This study aims to determine differences in procedures times between
      simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to
      improve the number of procedures/hour/unit during the COVID-19 era.
    

Detailed description: 
      Study type:

      This is a prospective controlled randomized study to determine differences in procedure times
      of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two
      groups: the serial group, where the EGD is performed first and thereafter the colonoscopy
      and, the simultaneous group, where the two procedures are performed at the same time, each by
      a trained gastroenterologist.

      Patients:

      Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter
      LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures
      include among others abdominal pain, screening for digestive cancer, chronic anemia,
      digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation
      with Boston score with at least 1 point in any segment, residual gastric food, previous
      digestive system surgery, and refusal to participate. Patients and their accompanying person
      give written consent of the procedures and are asked to complete a telephone survey related
      to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.

      Randomization:

      Endoscopists participating in the study are experts endoscopists. In both groups,
      colonoscopies are performed by the same expert endoscopist. EGD in the serial group is
      performed by the attending endoscopist responsible for procedures that day.

      Outcomes:

      Variables to be compared between groups include unit entry's time, time to completion of both
      procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum,
      withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and
      endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before,
      5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A
      trained physician or anesthesiologist will administrate sedation to patients using Propofol.
      Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the
      procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea,
      drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure:
      abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1
      to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

      Patient position and location of endoscopy systems:

      All patients are positioned in the left lateral decubitus position. For simultaneous
      procedures, the EGD tower is located to the left side and the colonoscopy tower at the right
      side of the bedside at the level patient's head.

      EGD:

      The systematic complete photodocumentation approach proposed by Emura et al will be carried
      out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo
      EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the
      hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation
      of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100
      insufflator.

      Colonoscopy in the serial group:

      A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2
      insufflation will be carried out with Fuji GW-100 equipment.

      Colonoscopy in the parallel-group:

      An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR
      insufflator will be used for CO2 insufflation.

      Transcutaneous measurement of pCo2:

      The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This
      equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and
      measures pCO2 non-invasively.
    

Intervention name(s): Simultaneous EGD and colonoscopy
Intervention type(s): Procedure
Intervention description(s): Patients are examined simultaneously by EGD and colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Combined simultaneous (CoSi) endoscopy; EGD; Colonoscopy