Clinical trial · Interventional
Clinical Trial Evaluating External Evaluation and Training on the Incomplete Resection (POLIPEVA Study)
Clinical Trial Evaluating the Effect of External Evaluation and Training on the Incomplete Resection Rate in Cold Snare Polypectomies in Colonic Lesions <10 Mm (POLIPEVA Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction It has been shown that some quality indicators in endoscopy can be improved through educational interventions. There are marked differences in the proportion of incomplete polypectomies among endoscopists. The effectiveness of measures to improve it has not been evaluated. Objective The main objective is to evaluate whether a training intervention or the notification of the individual proportion of incomplete polypectomies (those in which post-polypectomy biopsies of the resection margin show tissue other than normal mucosa) can improve this proportion. As secondary objectives, we will compare the proportion of fragmented polypectomies and adverse events. We will evaluate the factors associated with incomplete excision or failed cold polypectomy, as well as the individual evolution of the participants. Methods Non-pharmacological clinical trial involving endoscopists with\> 1 year of experience and patients scheduled for colonoscopy. After each polypectomy, 2 additional biopsies will be taken and evaluated centrally by a blind pathologist. In a first phase, the basal rate of the participants will be evaluated. After it, the endoscopists will receive a course on endoscopic polypectomy and the other their rate of complete resection. The number of polyps required will vary depending on the number of endoscopists The primary objective will be compared using logistic regression models based on generalized estimating equations (GEE), taking into account the within-subject correlation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyp | — | UNRESOLVED | — |
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonic polypectomy | Procedure | — | UNRESOLVED |
| Online training course | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- On-line training course
- description
- Each participant will receive the global data, the results obtained by all the endoscopists (anonymously except for each interested party, the rest being identified by codes), as well as a detailed analysis of their results, comparing them with the joint data and the 3 tertiles.
- interventionNames
- Procedure: Colonic polypectomy
- Behavioral: Online training course
Primary outcomes (1)
- measure
- Incomplete resection rate
- timeFrame
- One year
- description
- To compare the change in the proportion of incomplete cold-snare polypectomies in polyps \<10mm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age scheduled for a non-urgent colonoscopy. Exclusion Criteria: * Absence of lesions \<10 mm. * Contraindication for polypectomy (anticoagulant treatment that cannot be withdrawn, treatment with clopidogrel, coagulopathy or severe thrombocytopenia) * Loss of polypectomy specimen * Refusal to participate
References
Publications (15)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDRansohoff DF. Colon cancer screening in 2005: status and challenges. Gastroenterology. 2005 May;128(6):1685-95. doi: 10.1053/j.gastro.2005.04.005. No abstract available. PMID 15887159
- BACKGROUNDBaxter NN, Warren JL, Barrett MJ, Stukel TA, Doria-Rose VP. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol. 2012 Jul 20;30(21):2664-9. doi: 10.1200/JCO.2011.40.4772. Epub 2012 Jun 11. PMID 22689809
- BACKGROUNDBaxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15. PMID 19075198
- BACKGROUNDMulder SA, van Soest EM, Dieleman JP, van Rossum LG, Ouwendijk RJ, van Leerdam ME, Kuipers EJ. Exposure to colorectal examinations before a colorectal cancer diagnosis: a case-control study. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):437-43. doi: 10.1097/MEG.0b013e328333fc6a. PMID 19952765
- BACKGROUNDNishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969. PMID 24047059
- BACKGROUNDSingh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.