Patient-posture and Ileal-intubation during colonoscopy (PIC): a randomized controlled open-label trial

Abstract

Background: Colonoscopist change patient's posture to achieve complete ileocolonoscopic examination. Aim: Impact of the patient's posture (left lateral vs supine) on success rate of ileal intubation at colonoscopy. Methods: Prospectively all adult out-patients referred for colonoscopy and satisfying predefined inclusion criteria, underwent 1:1 randomization to undergo ileal intubation, either in left-lateral decubitus or supine posture, by sealed envelope method. Expecting a reported success of ileoscopy without any maneuver of ~80% and contemplating a 15% increase in success at ileal intubation in supine posture, a sample size of 216 (108 in each group) was needed with 90% power (alpha=0.05). After informed consent, colonoscopy (EC-201 WL, Fujinon) was carried out after overnight standard poly-ethylene glycol (PEG) based preparation, under conscious sedation with intravenous midazolam and continuous pulse-oxymetry monitoring. Bowel preparation adequacy was assessed by Boston Bowel Preparation Scale (BBPS). After confirmation of cecal intubation, the type of IC-valve was noted, and the patient was randomized for terminal ileal intubation. Partial suction and scope maneuvers were allowed. Successful ileal intubation was defined by visualization of ileal mucosa or villi (confirmed by digital photography) and was attempted until limited by pain or time of >6 minutes. Use of anti-peristalsis agents, biopsy forceps as an "anchor" to facilitate the IC- valve intubation, and intubation in the retroflexed position was not allowed. The study was approved by the IEC. Appropriate statistical analysis was performed with Fisher exact test, Student's t test and binary logistic regression analysis. A p value of <0.05 was considered significant. Results: 209/ 867 patients, 144 males, were randomized, 102 to left-lateral decubitus and 107 to supine posture. There was no difference in the baseline characteristics between the 2 groups. Successful intubation of terminal ileum was achieved in 141 (67.5%) patients overall, significantly higher rate in supine (81/107; 76%) versus left-lateral decubitus (60/102; 59%) posture (p=0.01). On multivariate analysis, supine posture (p=0.02), average/good right-colon preparation (p<0.05), non-thin-lipped IC-valve (p<0.0001) and younger age (p=0.03) were independent predictors of successful ileal intubation. Experience of endoscopist was not a significant factor. No complications were observed except for transient hypoxia in 1.9% and asymptomatic tachycardia in 16.3%. Abnormal ileal finding were recorded in 12/141 (8.5%). Conclusion: Ileoscopy is more successful in supine than left-lateral decubitus posture. Age, bowel preparation and type of IC-valve also determine successful ileoscopy. Our study achieved a power of 80% (alpha=0.05) on post-hoc analysis. CCT No: NCT01159886.