Clinical trial · Interventional
Towards Painless Colonoscopy
Towards Painless Colonoscopy: a Dedicated Training to Decrease the Rate of Painful Colonoscopy - a Randomized Controlled Trial
- 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)
One of the major barriers to CRC screening participation is a negative perception of colonoscopy as a painful and unpleasant procedure. Previously, by monitoring patient-reported outcomes as one of the colonoscopy quality performance measures, the investigators identified the endoscopist as the single, most important risk factor for painful colonoscopy. Therefore, the investigators propose a randomized controlled trial to analyse the effectiveness of directed training on the endoscopists painful colonoscopy rate. The study will be conducted in two phases: endoscopist categorization and design of training (I) and randomized controlled trial evaluating training effectiveness (II). Phase I will include endoscopists from Polish Colonoscopy Screening Programme (PCSP) willing to participate. Volunteers will be divided into underperformers, average performers and overperformers, based on their painful colonoscopy rate (obtained from PCSP database records) and will be invited to take part in the initial workshop focused on pain reduction during colonoscopy (conducted in a similar fashion to Train Colonoscopy Leaders (TCL) workshop, aiming at ADR improvement). On the basis of the differences in performance between over- and underperformers, categories of importance, target scores and a questionnaire for the assessment of factors for improvement will be developed. In Phase II, endoscopists from PCSP screening centres previously categorized as underperformers and average performers will be randomized in 1:1 ratio either to control (no intervention) or intervention arm. The subjects in the control arm will not be trained or informed about study participation. The endoscopists assigned to the intervention arm will be invited to take part in one training session designed in Phase I of the study (according to the evaluation questionnaire from Phase I). Willing overperformers will be asked to participate in the training as teachers. The training session will be divided into two parts: theoretical - presentation of research on painless colonoscopy - and practical - colonoscopy performance with commentary. Subjects matched 1:1 with trainers will take part in such a session, supervised by the study coordinator. Each endoscopist who underwent training in the second phase of the study will be sent a written, customized feedback on changes after the intervention and information about factors to improve (as per evaluation questionnaire from Phase I of the study). All endoscopists enrolled into Phase II will be followed through PCSP database for the endpoint of painful colonoscopy rate; the intervention arm will be compared with the control group at 6 and 12 months after feedback in order to investigate whether the adjusted painful colonoscopy rate improved as a result of the intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopist's training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- The intervention will consist of one training session, focusing on technical and non-technical aspects identified in the study Phase I (according to the evaluation questionnaire). The training will be conducted by a team consisting of (i) supervisors (researchers) and (ii) teachers experienced in the previous trial (Train-Colonoscopy-Leaders course - TCL; this methodology has already been evaluated (citation)). There will be 7 trainees per session: 1 under-, 4 average and 2 overperformers. The training session will be divided into two parts: theoretical and practical. During the first, theoretical part of the training, the body of research on the phenomenon of colonoscopy pain will be presented. The second, practical part of the training, will consist of a one-day session of 7 colonoscopies. Each average and underperforming endoscopist who underwent training in the randomized phase will receive a written, customized feedback on his/her performance during the training session.
- interventionNames
- Other: Endoscopist's training
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- The endoscopists in the control arm will not be informed about participation in the study and will receive only tailored feedback on adjusted painful colonoscopy rate (practice as usual). They will receive a reminder, that dedicated report on painful colonoscopy rate is provided in the Polish Colonoscopy Screening Program database and they will be monitored for endpoints through Polish Colonoscopy Screening Program database.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Endoscopists contributing to Polish Colonoscopy Screening Program * Endoscopists classified as underperformers and average performers, i.e. endoscopists performing above the adjusted mean rate of painful colonoscopies (with high adjusted painful colonoscopy rate), outside of confidence interval of 99% based on the number of performed colonoscopies, and performing inside the confidence interval of 99%, respectively. * Colonoscopy volume of at least 100 colonoscopies/year for at least 2 years prior to the study inclusion Exclusion Criteria: * Endoscopists from the PCSP coordinating centre * Endoscopists who have participated in the first phase of the study * Endoscopists classified as overperformers, i.e. performing below the adjusted mean rate of painful colonoscopies (with high adjusted painful colonoscopy rate), outside of confidence interval of 99% based on the number of performed colonoscopies.
References
Publications (1)
- RESULTKaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10. PMID 25670810