Reuse of Polyp Traps, a Way to Approach Sustainability (POLYPTRAP)

Reuse of Polyp Traps, a Way to Approach Sustainability: A Multicentric Non-inferiority Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cross Infection
• Intervention / Treatment: Other: Reuse or dispose a polyp trap

• Study Type: Observational
• Enrollment (Estimated): 3238

Contacts and Locations

• Study Contact: Name: Oliva Ros Fargas, nurse; Phone Number: +34 608 879 422; Email: oros@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who have undergone a colonoscopy in which a polyp trap was used.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reuse Group; patients from centres that routinely reuse polyp traps.	Other: Reuse or dispose a polyp trap; Participant hospitals will be separated into two groups, according to their standard clinical practice: A) reuse or B) dispose polyp traps after a colonoscopy with polypectomy. Centres will participate with their current method of using polyp traps. Work dynamics will not change as patients will be recruited from centers that routinely reuse or dispose polyp traps.
Single Use Group; patients from centres that dispose polyp traps after a single use.	Other: Reuse or dispose a polyp trap; Participant hospitals will be separated into two groups, according to their standard clinical practice: A) reuse or B) dispose polyp traps after a colonoscopy with polypectomy. Centres will participate with their current method of using polyp traps. Work dynamics will not change as patients will be recruited from centers that routinely reuse or dispose polyp traps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with symptoms suggesting infection	Did the patient present any of the following symptoms or diagnosis after the endoscopy?; Fever; Bacteraemia; Bronchoaspiration / Pneumonia; Other: Comments:; None	Follow up at day 15
Number of infectious events related to endoscopy	Was the event related to the endoscopy procedure? Yes / Probably / Doubtfully / No	Follow up at day 15
Number of infectious events related to polyp trap	Was the event related to the polyptrap? Yes / Probably / Doubtfully / No	Follow up at day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of inconsistent anatomopathological results	Was the anatomopathological finding consistent with the findings in the endoscopy?	Follow up at day 15

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Hospital Clinic of Barcelona; Germans Trias i Pujol Hospital; Hospital Universitario La Fe; Centro Medico Teknon; Hospital Universitari Joan XXIII de Tarragona.; Consorci Sanitari de Terrassa; Hospital Dos de Maig; Hospital Sant Bernabé de Berga; Clínica Mi Tres Torres Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: IIBSP-RPT-2024-69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No