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Towards Painless Colonoscopy

ABSTRACT: 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.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2316594 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The study has been described in the following paper: Gianni Parise, Stuart M. Phillips, Jan J. Kaczor and Mark A. Tarnopolsky (2005). Antioxidant enzyme activity is up-regulated after unilateral resistance exercise training in older adults. Free Radical Biology and Medicine, Volume 39, Issue 2, 15 July 2005, Pages 289-295 We cite the following three paragraphs from this paper: "MATERIALS AND METHODS Subjects Twelve men (71.2 ± 6.5 y) volunteered to participate in a 12 week uni-lateral leg resistance training program (Table 1). All subjects underwent a thorough screening process before being admitted into the study. Subjects were first screened by telephone, and were then subject to a medical evaluation. Consent from their family physician was required, and then all potential subjects underwent a resting electrocardiogram, and a sub-maximal graded exercise test on a bicycle ergometer witih a 12-lead ECG. Exclusion criteria included: evidence of coronary hear disease; congestive heart failure; uncontrolled hypertension; chronic obstructive pulmonary disease; diabetes mellitus; renal failure; major orthopaedic disability; and smoking. None of the subjects had ever participated in a structured exercise program. After subjects were advised of the benefits and risks of participation, subjects gave their written informed consent. The study was approved by the McMaster University and Hamilton Health Sciences Research Ethics Board and conferred to the principles of the declaration of Helsinki. Exercise Training Resistance training was performed three times weekly on non-consecutive days (Monday, Wednesday, and Friday) for 12 weeks, under strict supervision. Prior to and after each training session subjects were required to perform passive stretching. Resistance exercise for each session consisted of 3 sets of 10 repetitions for each of leg press and leg extension. Training progressed from one set of each exercise at 50% of the initial 1 repetition maximum (1RM) to 3 sets at 80% of 1RM over the training period. Training logs were kept to record the volume and intensity of each session. The 1RM was re-evaluated every 2 weeks, and the training load was adjusted accordingly. All exercises were performed on universal strength training equipment (Universal Gym Equipment, Inc., Cedar Rapids, Iowa). Muscle Biopsy A muscle biopsy was taken from the vastus lateralis muscle of both legs before as well as after the training period, 20 cm proximal to the knee joint using a modified Bergström needle (5 mm diameter) with suction modification. The biopsy specimen was dissected of fat and connective tissue and immediately frozen in liquid nitrogen. All samples were stored at -80 °C for subsequent analysis. All subjects were required to abstain from strenuous physical activity for 48 hours prior to the testing session. The non-trained leg performed an acute bout of exercise at the same relative intensity of the training leg to allow for the determination of the effect of training and the effect of acute resistance exercise." Additional Notes: 1) The samples of 8 out 12 were used in the gene expression study. 2) The 2 factors in this study are: 2.1) Leg - Left or Right 2.2) Training - Baseline: samples taken on each leg before exercise - Resistance Training: one of the legs was subject to resistance training followed by acute exercise - Acute Exercise: the other leg had only the acute exercise 3) The baseline samples will be used for right versus left leg comparison to see variance between legs for human experimentation technical issues. The samples from Resistance or Acute Exercise will be compared to corresponding baseline samples to evaluate the effect of both exercise programs on gene expression.

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Towards Painless Colonoscopy

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