LETTERS TO THE EDITOR Informed consent should not be obtained under duress To the Editor: We read the recent article by Kim et al1 with some incredulity regarding the manner in which informed consent was obtained. The authors state that in those patients undergoing an unsedated colonoscopy in whom the sigmoid colon was not transversed after 10 minutes, the instrument was withdrawn. The patients were then given an explanation of the proposed study with a cap and, if they agreed, were randomized to an E-cap or a C-cap. We think that informed consent should have been obtained well before the colonoscopic procedure was started. The recommendations of good clinical practice suggest at least 3 days before the scheduled appointment. It is clearly problematic to explain a research protocol to obtain informed consent after spending 10 minutes in an unsuccessful attempt to transverse the sigmoid colon. The patient is likely to be in some discomfort and fearful, and there is a possibility that the patient will see a refusal to consent as having implications for the next colonoscopy. If the patients did not consent, then they would presumably have to be rescheduled for an examination under sedation and another bowel preparation. It would clearly have been preferable to explain the research proposal before scheduling the colonoscopy. In our institutions, such a protocol would not have been passed by the institutional review board, and we suspect that this is the case also in the United States. The requirements for informed consent have rightly become more stringent in recent years and are universal. Stephen Malnick, MA, MSc MBBS Department of Internal Medicine C Kaplan Medical Center Rehovot, Israel Shelly Malnick School of Physiotherapy Haifa University Haifa, Israel REFERENCE 1. Kim D-H, Park S-Y, Park C-H. Cap-assisted gastroscope versus cap-assisted colonoscope for examination of difficult sigmoid colons in a nonsedated Asian population: a randomized study. Gastrointest Endosc 2014;79:790-7. http://dx.doi.org/10.1016/j.gie.2014.06.027
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Response: We agree with your comment. Informed consent should have been obtained well before the colonoscopic procedure was started. Actually, we obtained informed consent 2 times. First, all patients undergoing colonoscopy were given an explanation of the colonoscopy, including adverse events and options in case of intubation failure. They underwent colonoscopy after they gave informed consent. Second, if experienced colonoscopists failed to obtain passage through the sigmoid colon within 10 minutes with a standard colonoscope, the patient was informed about the study. Patients willing to participate were included after they gave informed consent and were then randomized to undergo a second colonoscopy by either a cap-assisted gastroscope or a cap-assisted colonoscope. If patients with a difficult sigmoid colon did not consent, then they underwent a second colonoscopy by either a cap-assisted gastroscope or a cap-assisted colonoscope according to their endoscopist’s subjective opinion. In addition, if they wanted sedation, they underwent sedation colonoscopy. We had to obtain the second informed consent only in patients with a difficult sigmoid colon. In our hospital, colonoscopies were performed on 8000 patients during the study period. Of those, 187 patients (2.33%) were considered to have a technically difficult sigmoid colon. If 8000 patients were given an explanation of the second colonoscopy in case of difficult sigmoid colon, they were likely to be in severe discomfort and fearful, and there was a possibility that they would see a refusal to consent as having implications for their initial colonoscopy. Our institutional review board would not have passed that protocol. All patients should have an opportunity for a better colonoscopy, even under duress. Chang-Hwan Park, MD, PhD Sun-Young Park, MD, PhD Department of Internal Medicine Chonnam National University Medical School Gwangju, Korea http://dx.doi.org/10.1016/j.gie.2014.06.029
Position change during colonoscope withdrawal: Is it worth the effort? To the Editor: We read with interest the study by Ou et al1 assessing the influence of position change on adenoma detection during colonoscope withdrawal. We were www.giejournal.org
914 GASTROINTESTINAL ENDOSCOPY Volume 80, No. 5 : 2014
Response: We agree with your comment. Informed consent should have been obtained well before the colonoscopic procedure was started. Actually, we obtained informed consent 2 times. First, all patients undergoing colonoscopy were given an explanation of the colonoscopy, including adverse events and options in case of intubation failure. They underwent colonoscopy after they gave informed consent. Second, if experienced colonoscopists failed to obtain passage through the sigmoid colon within 10 minutes with a standard colonoscope, the patient was informed about the study. Patients willing to participate were included after they gave informed consent and were then randomized to undergo a second colonoscopy by either a cap-assisted gastroscope or a cap-assisted colonoscope. If patients with a difficult sigmoid colon did not consent, then they underwent a second colonoscopy by either a cap-assisted gastroscope or a cap-assisted colonoscope according to their endoscopist’s subjective opinion. In addition, if they wanted sedation, they underwent sedation colonoscopy. We had to obtain the second informed consent only in patients with a difficult sigmoid colon. In our hospital, colonoscopies were performed on 8000 patients during the study period. Of those, 187 patients (2.33%) were considered to have a technically difficult sigmoid colon. If 8000 patients were given an explanation of the second colonoscopy in case of difficult sigmoid colon, they were likely to be in severe discomfort and fearful, and there was a possibility that they would see a refusal to consent as having implications for their initial colonoscopy. Our institutional review board would not have passed that protocol. All patients should have an opportunity for a better colonoscopy, even under duress. Chang-Hwan Park, MD, PhD Sun-Young Park, MD, PhD Department of Internal Medicine Chonnam National University Medical School Gwangju, Korea http://dx.doi.org/10.1016/j.gie.2014.06.029
Position change during colonoscope withdrawal: Is it worth the effort? To the Editor: We read with interest the study by Ou et al1 assessing the influence of position change on adenoma detection during colonoscope withdrawal. We were www.giejournal.org
