Clinical trial NCT06838312: Reuse of Polyp Traps, a Way to Approach Sustainability
Official title: Reuse of Polyp Traps, a Way to Approach Sustainability: A Multicentric Non-inferiority Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cross Infection
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: Consorci Sanitari de Terrassa
name: Hospital Clinic of Barcelona
name: Hospital Universitario La Fe
name: Hospital Sant Bernabé de Berga
name: Hospital Dos de Maig
name: Hospital Universitari Joan XXIII de Tarragona.
name: Centro Medico Teknon
name: Clínica Mi Tres Torres Barcelona
First posted: 2025-02-20
Enrollment: 3238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have undergone a colonoscopy in which a polyp trap was used.

Brief summary: The environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. For this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. One of the devices, widely used and which generates a large amount of waste, is the polyp trap. It allows an easy recovery of the polyps removed during endoscopy. This device is discarded after a single use in some centers, and reused after washing and disinfection in others. Manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. In the investigators endoscopy unit, 3800 polyp traps are used yearly. The investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. Objectives: To evaluate the safety of the reused and discarded after a single-use polyp trap. The investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) CO2 emissions and 4) costs of each practice. Methodology: A non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. The results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.


Eligibility criteria: Inclusion Criteria:

* All patients who undergo an elective colonoscopy will be recruited for the study.

  * Written informed consent to participate in the study and willingness to be contacted by telephone for follow-up.

Exclusion Criteria:

* Patients who complete the colonoscopy without a polypectomy.
* Patients who complete the colonoscopy without the use of a polyp trap.

Primary outcomes:
measure: Number of patients with symptoms suggesting infection
timeFrame: Follow up at day 15
measure: Number of infectious events related to endoscopy
timeFrame: Follow up at day 15
measure: Number of infectious events related to polyp trap
timeFrame: Follow up at day 15
Secondary outcomes:
measure: Number of inconsistent anatomopathological results
timeFrame: Follow up at day 15
Other outcomes:
Locations:
Study officials:
References: