Reuse of Polyp Traps, a Way to Approach Sustainability

NCT06838312 | Not Yet Recruiting

• 1 other identifier: IIBSP-RPT-2024-69
• Study Type: observational
• Target: 3,238
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cross Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of inconsistent anatomopathological results

  Follow up at day 15

Study Arms (2)

Reuse Group

patients from centres that routinely reuse polyp traps.

Other: Reuse or dispose a polyp trap

Single Use Group

patients from centres that dispose polyp traps after a single use.

Other: Reuse or dispose a polyp trap

Interventions

Reuse or dispose a polyp trap OTHER

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.

Reuse Group; Single Use Group

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oliva Ros Fargas, nurse

CONTACT

+34 608 879 422; oros@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: February 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share