Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg...
Irritable Bowel SyndromeAbdominal Pain2 moreThis is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®). This study is conducted as part of a future multicenter randomized controlled trial that will assess the therapeutic effect of the new peppermint oil formulation in IBS patients.
Three Distraction Methods for Pain Reduction During Colonoscopy
ColonoscopyColon DiseaseColonoscopy is a common procedure to evaluate the gastrointestinal tract. The colonoscopy procedure can sometimes be uncomfortable and painful for the patient. The aim of this study was to compare the effects on pain and anxiety of distraction methods used during colonoscopy. Single centre, randomized, parallel-group trial. Endoscopy unit of a training and research hospital in northern Turkey A total of 120 patients were recruited and randomized into four groups as music, stress ball, video, and control group. The data were collected using Visual Analog Scale for pain and satisfaction, State-Trait Anxiety Inventory for anxiety, and hemodynamic parameters. Data collection continues
Colon Cleansing Efficacy With 1L vs. 2L vs. 4L-PEG for Colonoscopy Among Inpatients
Colon DiseaseAn adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two. Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Colonic DiseasesThis multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)
Prospective Phase II Randomized Trial of Postoperative Adjuvant Chemotherapy in Patients With High...
Colonic DiseasesAdenocarcinomaBased on the astonishing high response rate in metastatic colorectal cancer in weekly high dose 5-FU and leucovorin, we will conduct a clinical trial to clarify the activity of this regimen in the adjuvant setting. The regimen of 5-FU and high dose leucovorin administered as the schedule of INT-0089 will be chosen as the controlled arm which was proven as effective as standard 5-FU plus levamisole regimen with short duration of treatment.21 In this study, continuous infusion of 5-FU (HDFL, Arm B) and bolus injection of 5-FU (Arm A) will be administered to the high risk colon cancer(N2 disease) patients. The role of TS level and inhibition of TS as a predictor of adjuvant chemotherapy with 5-FU based treatment will be clearly defined prospectively.
Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality...
Colonic DiseasesBackground: Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in Spain. Colon cleansing is critical for visualization of lesions at colonoscopy. High-quality cleansing allows for correct detection and resection of all lesions and may contribute to adequate risk stratification and follow-up interval. Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its effectiveness. Currently, the most widely used low-volume laxatives are one liter of Polyethylene glycol + ascorbate (PEG1A) and sodium picosulfate + magnesium citrate (PSCM). The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is very scarce. Hypothesis: Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium citrate in high-quality colon cleansing. Objective: Overall objective: To compare the global high-quality cleansing frequency between the two laxatives using the Harefield Scale (HS). The primary objective is to demonstrate non-inferiority in global high-quality cleansing of PEG1A compared to PSCM. If non-inferiority is demonstrated, superiority of PEG1A will be analyzed. Specific objectives: Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale (BBPS). Frequency of adequate-quality cleansing using the HS and BBPS scales. Tolerance and adverse effects of both laxatives. Detection of lesions, total adenomas, advanced adenomas, total serrated lesions, advanced serrated lesions and colorectal cancer. Detection of neoplastic lesions in the different colon segments (proximal, transverse, descending, sigmoid and rectum). Association between detected lesions and the quality of the preparation, according to the HS and BBPS scales. Methods: Phase 4, multi-centric, randomized, single-blind (endoscopist), parallel study with two treatment arms: PEG1A (Pleinvue®) and PSCM (Citrafleet®).
Adequacy of Anaesthesia for Colonoscopic Procedures
Colonic DiseasesFunctionalThe aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain perception intraoperatively and its influence on postoperative pain perception, both patients' and operators' satisfaction in patients undergoing colonoscopic procedures under intravenous sedation using propofol and fentanyl.
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Colonic PolypColonic Neoplasms5 more61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
Colonic DiseasesBowel DiseasesTo evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy
Colonic DiseasesDexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy