- Email: [email protected]
Patient tolerance of colonoscopy without sedation during screening examination for colorectal polyps
Patient tolerance of colonoscopy without sedation during screening examination for colorectal polyps Espen Thiis-Evensen, MD, Geir S. Hoff, MD, PhD, Jostein Sauar, MD, PhD, Morten H. Vatn, MD, PhD Skien and Oslo, Norway
Background: The administration of sedative drugs at colonoscopy has its drawbacks such as increases in the rate of complications and cost. Our aim was to study how individuals, drawn from a population registry and invited to undergo screening colonoscopy for colorectal polyps, experienced the procedure without conscious sedation. Methods: Four hundred fifty-one individuals underwent the screening examination (median age 67 years, range 63 to 72). The cecum was intubated in 369 (82%). Fourteen days after the examination, 429 of the attendees received a questionnaire designed to evaluate their tolerance of the procedure. Results: Four hundred nine participants (95%) replied. Twenty-one (5%) of these individuals found the examination very uncomfortable, 184 (45%) found it moderately uncomfortable, and 204 (50%) did not find it uncomfortable. A larger proportion of women than men, 110 (63%) versus 79 (41%), found the procedure very or moderately uncomfortable (p < 0.001). Three hundred sixty-eight (90%) individuals stated that they would undergo repeat colonoscopy in 5 years. Conclusion: In this screening setting, routine use of conscious sedation did not seem to be necessary, as most participants found the examination to be only moderately uncomfortable or not at all uncomfortable. Colonoscopy without conscious sedation may, however, reduce the rate of intubation of the cecum and increase the risk of missing adenomas and cancers. (Gastrointest Endosc 2000;52:606-10.)
Colonoscopy with procurement of biopsies is the standard examination for detection of colon pathology, but the examination is regarded as uncomfortable and painful. Sedative drugs are often administered to reduce discomfort, and in some Western countries conscious sedation is given routinely.1,2 Conscious sedation might, however, be associated with an increased frequency of complications,1,3-6 increased cost of surveillance and monitoring during and after the procedure,7 lingering side effects of sedative drugs, reduced ability to comprehend information during and after colonoscopy,6 and a longer recovery period for the patient. We have evaluated how attendees randomly drawn from a population registry, age 63 to 72 years, tolerated a colonoscopic screening examination for colorectal polyps without the use of sedative drugs, and their willingness to undergo a repeat procedure. Received September 21, 1999. For revision March 14, 2000. Accepted June 30, 2000. From the Department of Medicine, Telemark Central Hospital, Skien; Department A of Medicine, Rikshospitalet University Hospital, Oslo, Norway. Supported in part through grants from the Norwegian Cancer Society. Reprint requests: E. Thiis-Evensen, Dept. of Medicine, Rikshospital University Hospital, N-0027 Oslo, Norway; fax 4723-073-643; e-mail: [email protected] Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/1/109804 doi:10.1067/mge.2000.109804 606
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PATIENTS AND METHODS A randomized controlled prospective study of the effect of polypectomy on the incidence of colorectal cancer was started in 1983 in Telemark County, Norway.8 Four hundred men and women, age 50 to 59 years, were drawn from the population registry and offered a flexible sigmoidoscopy. Those found to have polyps were offered a colonoscopy with polypectomy and follow-up colonoscopies in 1985 and 1989. Another 399 individuals from the same cohort were drawn from the registry and enrolled as a control group. This group was not given any attention until 1996 when all survivors in both the screening group and the control group were invited by a personal letter to undergo a colonoscopy to include polypectomy if indicated. Of the original screening and control group from 1983, a total of 693 individuals (87%) were alive in 1996. Two had emigrated, and those who had declined to undergo the screening examination in 1983 after receiving one reminder were excluded (n = 76), leaving 633 individuals eligible for the screening examination. Four hundred fiftyone (71%) attended; 217 (48%) were women and 210 (47%) were from the screening group. Examination in 1996 The participants were given a choice of a flexible sigmoidoscopic examination with cleansing limited to a 240 mL sorbitol enema on arrival for the procedure or a full colonoscopic examination, the latter being recommended. On the day of the examination a complete medical and family history was recorded. All endoscopies except one were done by the same endoscopist (E.T-E.) using a videocolonoscope (IT 100; Olympus Optical Co. [Europa], Hamburg, Germany). VOLUME 52, NO. 5, 2000
Colonoscopy without sedation for polyp screening
Table 1. Demographic and clinical data for individuals participating in the questionnaire survey Screening attendees (n = 429) Age (median, range) Men Women Body mass index (kg/m2, median, range) Atherosclerotic disease* Diabetes mellitus Inflammatory bowel disease Previously diagnosed non-CRC cancer Previous diagnosed CRC Current smoker Past smoker Bowel movements per week (median, range) Abdominal complaints† First-degree relative with colorectal cancer
67 (63-72) 221 (52) 208 (48) 25 (15-40) 72 (17) 16 (4) 3 (0.7) 24 (6) 6 (1) 118 (27) 117 (27) 7 (1-30) 81 (19) 35 (8)
Percentages given in brackets if not otherwise stated. *Includes coronary heart disease, intermittent claudication and cerebrovascular strokes. †Includes constipation, irritable bowel syndrome, loose stools, diarrhea, pain, flatulence, hemorrhoids, mucus in the stools and anal pruritus, either isolated or in combinations.
Large polyps were removed by electrosurgical snare polypectomy, whereas smaller polyps were removed with standard (cold) biopsy forceps. Sedative or analgesic drugs were not given at the start of the examination to any of the participants, except for one individual who insisted and was given 3 mg of midazolam intravenously. Sedation or analgesia “as required” was not given to any of the participants. Thirty-one individuals (7%) underwent sigmoidoscopy alone. One hundred forty-eight of the women (68%) and 185 of the men (79%) had polyps detected and removed. Histologic examination of these polyps showed that 68 women (31%) and 112 men (48%) had had adenomas. Colorectal cancer was diagnosed in two individuals. The cecum was intubated in 346 (86%) of those prepared for colonoscopy and in 10 (32%) of those having only limited bowel cleansing for sigmoidoscopy. Eighteen of the 451 individuals had been included in the polyp screening study without undergoing a study-colonoscopy because they had had a lower endoscopy due to GI symptoms within the last 6 months. Of these, the cecum was intubated in 13 (72%). The median duration of the procedure when polyps were removed was 30 minutes (range 10 to 95 minutes) and 25 minutes (range 10 to 95 minutes) when polyps were not discovered. Questionnaire survey On the day of the screening examination, all participants agreed to take part in a postal questionnaire survey. This was designed to evaluate the participant’s experience with endoscopic screening examination and to study the psychologic effect of participating in a screening program for colorectal neoplasia.9 The 18 individuals who had been included in the polyp screening study without having to undergo a study-colonoscopy, the 2 individuals with coloVOLUME 52, NO. 5, 2000
E Thiis-Evensen, G Hoff, J Sauar, et al.
Table 2. Questions in the post-screening questionnaire mailed to the participants after the endoscopic examination; participants were asked to circle their answer Were polyps found at the examination?
Did you find the examination uncomfortable?
Would you attend a repeat examination in 5 years time?
Yes No Do not remember Yes, very Moderately No Yes No Do not know
rectal cancer, and 2 others with newly diagnosed malignant disease were excluded from the present study. The questionnaire was mailed to a total of 429 individuals 14 days after they had been examined (Table 1). The part of the questionnaire used in the present study consisted of nine questions, registering gender, age, whether they had had polyps detected, whether they had had sigmoidoscopy or colonoscopy, and whether they found the examination to be uncomfortable (Table 2). The questionnaires were marked to make it possible to differentiate those responding from the original screening and control groups. Most investigators have used the term “pain” in questioning patients about their tolerance for endoscopic procedures.7,10,11 In our experience many patients find the procedure uncomfortable and distressing, but not painful. “Pain” as a variable for evaluation was therefore considered inappropriate in this study, and we used the term “uncomfortable” in our questionnaire. To detect any time-dependent change in the perception of the examination, the same questionnaire was mailed to the study participants again 3 and 17 months after the examination. The questionnaires were returned anonymously, hence no reminder was mailed to non-repliers. Statistics Yates chi-square test was used to evaluate differences between proportions in frequency tables. Fisher’s exact test was used when the frequencies were small. A twosided p value of 0.05 or less was considered statistically significant. For computing the data, SPSS 8.0 statistical software was used (SPSS Inc., Chicago, Ill.). Ethics The study was approved by the regional ethics committee and performed in accordance with the Helsinki declaration. Each participant provided informed consent for participation in the study.
RESULTS Four hundred nine individuals (95%) returned the questionnaire they received 14 days after the examination. Thirty-nine questionnaires (10%) were returned with no specification of gender. The mediGASTROINTESTINAL ENDOSCOPY
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Colonoscopy without sedation for polyp screening
Table 3. How the endoscopic screening examination was assessed by the attendees 14 days after the procedure All participants (n = 409) Men (n = 195) Women (n = 175) Gender not stated (n = 39) With polyps removed (n = 294) Without polyps removed (n = 96) Polyp status not stated (n = 19) Original screening group (n = 196) Original control group (n = 212) Group not stated (n = 1) Attending colonoscopy (n = 373) Attending sigmoidoscopy (n = 27)
Very uncomfortable
Moderately uncomfortable
21 (5) 10 (5) 8 (5) 3 (8) 17 (6) 4 (4) 0 10 (5) 11 (5)
184 (45) 69 (35) 102 (58) 13 (33) 135 (46) 40 (42) 9 (47) 89 (45) 94 (44) 1 166 (45) 15 (56)
18 (5) 2 (7)
Not uncomfortable 204 116 65 23 142 52 10 97 107
(50) (59) (37) (59) (48) (52) (53) (50) (51)
189 (51) 10 (37)
Participants are divided into subgroups depending on gender, whether polyps were removed at the examination, whether the patient belonged to the original screening or control group, and whether colonoscopy or sigmoidoscopy was performed. Numbers represent individuals (percent).
an age was 67 years (range 63 to 72). Among the participants who had marked their gender on the questionnaire, 175 (47%) were women. Three hundred seventy-three (91%) had undergone a colonoscopy and 27 (7%) sigmoidoscopy. Nine individuals (2%) had not indicated on the questionnaire whether they had undergone sigmoidoscopy or colonoscopy. A total of 21 individuals (5%) found the examination very uncomfortable, 184 (45%) found it moderately uncomfortable, and 204 (50%) found the examination not uncomfortable (Table 3). Gender and discomfort The same proportion of men and women found the examination very uncomfortable (Table 3). When comparing the proportion of participants who found the examination very and moderately uncomfortable, 79 men (41%) and 110 women (63%), with the proportion of participants who found the examination not uncomfortable, 116 men (59%) and 65 women (37%), the relative risk (RR) of experiencing the examination as uncomfortable for women versus men was 1.6 (95% CI [1.3, 2.0], p < 0.001). Polyp removal and discomfort One hundred fifty-two (52%) of those who had polyps removed and 44 (46%) of those who did not have polyps removed found the examination uncomfortable (Table 3). This gives an RR of 1.1 (95% CI [0.9, 1.4], p = 0.3) for experiencing the examination as uncomfortable when polyps were removed compared with examinations in which polyps were not removed. Discomfort and previous colonoscopy There was no difference in how the examination was experienced between the original screening 608
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group who earlier had been subjected to one or more study lower endoscopies, and the control group where 48 (12%) had had a previous non-study lower endoscopy (Table 3). One individual had removed the marking that indicated which group he or she belonged to. Discomfort at sigmoidoscopy versus colonoscopy One hundred eighty-four (49%) individuals who underwent colonoscopy found the examination uncomfortable, whereas 17 (63%) who had sigmoidoscopy found the examination uncomfortable (Table 3). This gives an RR of 1.3 (95% CI [0.8, 1.7], p = 0.2) for experiencing the examination as uncomfortable when choosing sigmoidoscopy compared with colonoscopy. Willingness to repeat the examination in 5 years Three hundred sixty-eight individuals (90%) stated that they would undergo and 9 (2%) stated they would not undergo another examination in 5 years. Of these 9 individuals, 8 found the examination uncomfortable (4 found it very uncomfortable). Of those who stated they would undergo a new examination, 162 (46%) experienced the examination as uncomfortable, giving an RR of 1.9 (95% CI [1.1, 2.2], p = 0.02) for turning down an offer of a repeat examination if the examination was experienced as uncomfortable. Results at 3 months and 17 months At 3 and 17 months after the examination, 395 (92%) and 389 (91%) individuals, respectively, returned their questionnaires. Twenty-one (5%) and 20 (5%) stated at 3 and 17 months, respectively, that the examination was very uncomfortable; 172 (44%) and 173 (44%), respectively, evaluated the examination as moderately uncomfortable. VOLUME 52, NO. 5, 2000
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DISCUSSION Despite undergoing procedures without conscious sedation, 95% of study participants assessed the examination as not uncomfortable or only moderately uncomfortable, and 90% stated that they would undergo another examination in 5 years. In other studies, 4% to 20% of patients undergoing lower endoscopies without conscious sedation have reported severe pain.7,10,11 Our results are not directly comparable with those of the aforementioned studies. We used the term “uncomfortable” rather than “pain” in the questionnaire, and our data were not obtained immediately after the examination but about 14 days later. This time frame was used because of a concern that responses obtained immediately or shortly after a procedure would be too strongly influenced by the immediate relief after a successful examination with no significant pathologic condition detected. Hoffman et al.11 found no difference in the perception of pain during the procedure when assessed immediately after the examination and 2 to 5 days later. The responses provided by participants in the present study at 3 and 17 months after the examination were similar to those given 14 days after the examination. Thus, it appears that the perception of discomfort during the examination is little influenced by time. Other investigators have found that patients younger than our study participants tolerate endoscopic procedures less well.10,12 More individuals assessing the examination as uncomfortable might have been found if younger individuals had been included in our study. The narrow age range (63 to 72 years) prevents further analysis of this relationship using data from our study. Women found the examination more uncomfortable then men. Other investigators have obtained the same result,6,10,12 and it has been postulated that this might be due to a more tortuous sigmoid colon in women. Previous gynecologic operations such as hysterectomy with development of sigmoid colon adhesions may also contribute to the increased perception of pain in women.10 The attendance rate for the screening examination was 71%. It has been shown that people who comply with screening examinations are a selected group within the population.13-15 Those who do not accept screening examinations might have higher anxiety levels and therefore a lower tolerance for endoscopic procedures.12,16 Similar to previous findings,6 there was no correlation between tolerance and a previous lower endoscopy. The cecum was intubated in 86% of participants who presented for colonoscopy. This is less than that VOLUME 52, NO. 5, 2000
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reported in some studies in which patient tolerance was evaluated and where a 94% to 97% success rate for intubating to the cecum has been achieved.7,11,17 Reports of other studies have not included the success rate, which makes it difficult to evaluate the results.6,10,12 If we had pushed on to achieve a higher success rate, the proportion of individuals who experienced the examination as uncomfortable would certainly have been higher. For example, if we had pushed on to achieve a 95% success rate instead of 85% and if all these additional patients in whom the cecum was successfully intubated gave reports of severe discomfort, the total proportion of individuals experiencing severe discomfort could have been as high as 15%. It might be considered as less important to intubate the cecum in a screening setting compared with an examination performed because of symptoms that raised a suspicion of colorectal cancer. The experience of pain and discomfort will affect compliance for screening and surveillance, and the endoscopist might therefore be more inclined to discontinue what is causing discomfort in an asymptomatic participant. Pain and discomfort experienced by patients during colonoscopy also depend on the skill and technique of the endoscopist.10 The results of our study are based on examinations performed by a single endoscopist. The percentage of individuals who experienced the examination as uncomfortable, among those who underwent a sigmoidoscopy compared with those attending for colonoscopy, was somewhat higher, though not statistically significant. The sigmoidoscopy group had, however, a high degree of self-selection bias as it consisted of individuals who rejected the recommendation to choose colonoscopy. The intravenous administration of sedative drugs at colonoscopy seems to be dependent on cultural factors18; few hard data exist to justify their use. For example, the routine use of conscious sedation at barium enemas has never been suggested even though Eckhardt et al.19 have shown that there is no difference in procedure-related discomfort between colonoscopy and barium enema. Ristikankare et al.20 did not find any marked increase in patient tolerance with the use of conscious sedation. The administration of sedative drugs to individuals only when, and if, they experience pain during the examination may be a practical approach to this issue.21 This would combine the positive effects of sedation and reduce the rate of sedation-induced complications.22 In conclusion, the routine administration of sedative drugs did not seem to be necessary in a setting of colonoscopic screening for colorectal polyps among individuals from a normal population in the GASTROINTESTINAL ENDOSCOPY
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age group 63 to 72 years. The lack of conscious sedation may, however, increase the duration of the procedure and reduce the proportion of participants in whom the cecum is visualized, and some adenomas and cancers might therefore be missed. This has to be weighed against the increase in cost of screening, increase in complications, and longer recovery period for patients associated with conscious sedation. REFERENCES 1. Daneshmend TK, Bell GD, Logan RFA. Sedation for upper gastrointestinal endoscopy: results of a nationwide survey. Gut 1991;32:12-5. 2. Keeffe EB, O’Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc 1990;36:S13-8. 3. Quine MA, Bell GD, McCloy RF, Charlton JE, Devlin HB, Hopkins A. Prospective audit of upper gastrointestinal endoscopy in two regions of England: safety, staffing, and sedation methods. Gut 1995;36:462-7. 4. Hart R, Classen M. Complications of diagnostic gastrointestinal endoscopy. Endoscopy 1990;22:229-33. 5. Arrowsmith JB, Gerstman BB, Fleischer DE, Benjamin SB. Results from the American Society for Gastrointestinal endoscopy/ U.S. Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy. Gastrointest Endosc 1991;37:421-7. 6. Froehlich F, Thorens J, Schwizer W, Preisig M, Köhler M, Hays RD, et al. Sedation and analgesia for colonoscopy: patient tolerance, pain, and cardiorespiratory parameters. Gastrointest Endosc 1997;45:1-9. 7. Cataldo PA. Colonoscopy without sedation. A viable alternative. Dis Colon Rectum 1996;39:257-61. 8. Thiis-Evensen E, Hoff GS, Sauar J, Langmark F, Majak MB, Vatn MH. Population-based surveillance by colonoscopy: Effect on the incidence of colorectal cancer. Telemark polyp study I. Scand J Gastroenterol 1999;34:414-20. 9. Thiis-Evensen E, Wilhelmsen I, Hoff SG, Blomhoff S, Sauar J. The psychologic effect of attending a screening program for colorectal cancer. Scand J Gastroenterol 1999;34:103-9.
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10. Hull T, Church JM. Colonoscopy-how difficult, how painful? Surg Endosc 1994;8:784-87. 11. Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol 1998;26:279-82. 12. Martin JP, Arlett PA, Holdstock G. Development of a sedation policy for upper GI endoscopy based on an audit of patients’ perception of the procedure. Eur J Gastroenterol Hepatol 1996;8:355-7. 13. MacLean U, Sinfield D, Klein S, Harnden B. Women who decline breast screening. J Epidemiol Community Health 1984;38:278-83. 14. Hayward RA, Shapiro MF, Freeman HE, Corey CR. Who gets screened for cervical and breast cancer? Results from a new national survey. Arch Intern Med 1988;148:1177-81. 15. Farrands PA, Hardcastle JD, Chamberlain J, Moss S. Factors affecting compliance with screening for colorectal cancer. Community Med 1984;6:12-9. 16. Preisig M, Froehlich F, Thorens J, Schwizer W, Gonvers JJ. Impact of anxiety and personality on tolerance and pain during colonoscopy [abstract]. Gastrointest Endosc 1997;45:AB55. 17. Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc 1999;49:554-9. 18. Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol 1999;94:1862-5. 19. Eckardt VF, Kanzler G, Willems D, Eckardt AJ, Bernhard G. Colonoscopy without premedication versus barium enema: a comparison of patient discomfort. Gastrointest Endoscopy 1996;44:177-80. 20. Ristikankare M, Hartikainen J, Heikkinen M, Janatuinen E, Julkunen R. Is routinely given conscious sedation of benefit during colonoscopy? Gastrointest Endosc 1999;49:566-72. 21. Stermer E, Gaitini L, Yudashkin M, Essaian G, Tamir A. Patient-controlled analgesia for conscious sedation during colonoscopy: a randomized controlled study. Gastrointest Endosc 2000;51:278-81. 22. Eckardt VF, Kanzler G, Schmitt T, Eckardt AJ, Bernhard G. Complications and adverse effects of colonoscopy with selective sedation. Gastrointest Endosc 1999;49:560-5.
VOLUME 52, NO. 5, 2000
Background: The administration of sedative drugs at colonoscopy has its drawbacks such as increases in the rate of complications and cost. Our aim was to study how individuals, drawn from a population registry and invited to undergo screening colonoscopy for colorectal polyps, experienced the procedure without conscious sedation. Methods: Four hundred fifty-one individuals underwent the screening examination (median age 67 years, range 63 to 72). The cecum was intubated in 369 (82%). Fourteen days after the examination, 429 of the attendees received a questionnaire designed to evaluate their tolerance of the procedure. Results: Four hundred nine participants (95%) replied. Twenty-one (5%) of these individuals found the examination very uncomfortable, 184 (45%) found it moderately uncomfortable, and 204 (50%) did not find it uncomfortable. A larger proportion of women than men, 110 (63%) versus 79 (41%), found the procedure very or moderately uncomfortable (p < 0.001). Three hundred sixty-eight (90%) individuals stated that they would undergo repeat colonoscopy in 5 years. Conclusion: In this screening setting, routine use of conscious sedation did not seem to be necessary, as most participants found the examination to be only moderately uncomfortable or not at all uncomfortable. Colonoscopy without conscious sedation may, however, reduce the rate of intubation of the cecum and increase the risk of missing adenomas and cancers. (Gastrointest Endosc 2000;52:606-10.)
Colonoscopy with procurement of biopsies is the standard examination for detection of colon pathology, but the examination is regarded as uncomfortable and painful. Sedative drugs are often administered to reduce discomfort, and in some Western countries conscious sedation is given routinely.1,2 Conscious sedation might, however, be associated with an increased frequency of complications,1,3-6 increased cost of surveillance and monitoring during and after the procedure,7 lingering side effects of sedative drugs, reduced ability to comprehend information during and after colonoscopy,6 and a longer recovery period for the patient. We have evaluated how attendees randomly drawn from a population registry, age 63 to 72 years, tolerated a colonoscopic screening examination for colorectal polyps without the use of sedative drugs, and their willingness to undergo a repeat procedure. Received September 21, 1999. For revision March 14, 2000. Accepted June 30, 2000. From the Department of Medicine, Telemark Central Hospital, Skien; Department A of Medicine, Rikshospitalet University Hospital, Oslo, Norway. Supported in part through grants from the Norwegian Cancer Society. Reprint requests: E. Thiis-Evensen, Dept. of Medicine, Rikshospital University Hospital, N-0027 Oslo, Norway; fax 4723-073-643; e-mail: [email protected] Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/1/109804 doi:10.1067/mge.2000.109804 606
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PATIENTS AND METHODS A randomized controlled prospective study of the effect of polypectomy on the incidence of colorectal cancer was started in 1983 in Telemark County, Norway.8 Four hundred men and women, age 50 to 59 years, were drawn from the population registry and offered a flexible sigmoidoscopy. Those found to have polyps were offered a colonoscopy with polypectomy and follow-up colonoscopies in 1985 and 1989. Another 399 individuals from the same cohort were drawn from the registry and enrolled as a control group. This group was not given any attention until 1996 when all survivors in both the screening group and the control group were invited by a personal letter to undergo a colonoscopy to include polypectomy if indicated. Of the original screening and control group from 1983, a total of 693 individuals (87%) were alive in 1996. Two had emigrated, and those who had declined to undergo the screening examination in 1983 after receiving one reminder were excluded (n = 76), leaving 633 individuals eligible for the screening examination. Four hundred fiftyone (71%) attended; 217 (48%) were women and 210 (47%) were from the screening group. Examination in 1996 The participants were given a choice of a flexible sigmoidoscopic examination with cleansing limited to a 240 mL sorbitol enema on arrival for the procedure or a full colonoscopic examination, the latter being recommended. On the day of the examination a complete medical and family history was recorded. All endoscopies except one were done by the same endoscopist (E.T-E.) using a videocolonoscope (IT 100; Olympus Optical Co. [Europa], Hamburg, Germany). VOLUME 52, NO. 5, 2000
Colonoscopy without sedation for polyp screening
Table 1. Demographic and clinical data for individuals participating in the questionnaire survey Screening attendees (n = 429) Age (median, range) Men Women Body mass index (kg/m2, median, range) Atherosclerotic disease* Diabetes mellitus Inflammatory bowel disease Previously diagnosed non-CRC cancer Previous diagnosed CRC Current smoker Past smoker Bowel movements per week (median, range) Abdominal complaints† First-degree relative with colorectal cancer
67 (63-72) 221 (52) 208 (48) 25 (15-40) 72 (17) 16 (4) 3 (0.7) 24 (6) 6 (1) 118 (27) 117 (27) 7 (1-30) 81 (19) 35 (8)
Percentages given in brackets if not otherwise stated. *Includes coronary heart disease, intermittent claudication and cerebrovascular strokes. †Includes constipation, irritable bowel syndrome, loose stools, diarrhea, pain, flatulence, hemorrhoids, mucus in the stools and anal pruritus, either isolated or in combinations.
Large polyps were removed by electrosurgical snare polypectomy, whereas smaller polyps were removed with standard (cold) biopsy forceps. Sedative or analgesic drugs were not given at the start of the examination to any of the participants, except for one individual who insisted and was given 3 mg of midazolam intravenously. Sedation or analgesia “as required” was not given to any of the participants. Thirty-one individuals (7%) underwent sigmoidoscopy alone. One hundred forty-eight of the women (68%) and 185 of the men (79%) had polyps detected and removed. Histologic examination of these polyps showed that 68 women (31%) and 112 men (48%) had had adenomas. Colorectal cancer was diagnosed in two individuals. The cecum was intubated in 346 (86%) of those prepared for colonoscopy and in 10 (32%) of those having only limited bowel cleansing for sigmoidoscopy. Eighteen of the 451 individuals had been included in the polyp screening study without undergoing a study-colonoscopy because they had had a lower endoscopy due to GI symptoms within the last 6 months. Of these, the cecum was intubated in 13 (72%). The median duration of the procedure when polyps were removed was 30 minutes (range 10 to 95 minutes) and 25 minutes (range 10 to 95 minutes) when polyps were not discovered. Questionnaire survey On the day of the screening examination, all participants agreed to take part in a postal questionnaire survey. This was designed to evaluate the participant’s experience with endoscopic screening examination and to study the psychologic effect of participating in a screening program for colorectal neoplasia.9 The 18 individuals who had been included in the polyp screening study without having to undergo a study-colonoscopy, the 2 individuals with coloVOLUME 52, NO. 5, 2000
E Thiis-Evensen, G Hoff, J Sauar, et al.
Table 2. Questions in the post-screening questionnaire mailed to the participants after the endoscopic examination; participants were asked to circle their answer Were polyps found at the examination?
Did you find the examination uncomfortable?
Would you attend a repeat examination in 5 years time?
Yes No Do not remember Yes, very Moderately No Yes No Do not know
rectal cancer, and 2 others with newly diagnosed malignant disease were excluded from the present study. The questionnaire was mailed to a total of 429 individuals 14 days after they had been examined (Table 1). The part of the questionnaire used in the present study consisted of nine questions, registering gender, age, whether they had had polyps detected, whether they had had sigmoidoscopy or colonoscopy, and whether they found the examination to be uncomfortable (Table 2). The questionnaires were marked to make it possible to differentiate those responding from the original screening and control groups. Most investigators have used the term “pain” in questioning patients about their tolerance for endoscopic procedures.7,10,11 In our experience many patients find the procedure uncomfortable and distressing, but not painful. “Pain” as a variable for evaluation was therefore considered inappropriate in this study, and we used the term “uncomfortable” in our questionnaire. To detect any time-dependent change in the perception of the examination, the same questionnaire was mailed to the study participants again 3 and 17 months after the examination. The questionnaires were returned anonymously, hence no reminder was mailed to non-repliers. Statistics Yates chi-square test was used to evaluate differences between proportions in frequency tables. Fisher’s exact test was used when the frequencies were small. A twosided p value of 0.05 or less was considered statistically significant. For computing the data, SPSS 8.0 statistical software was used (SPSS Inc., Chicago, Ill.). Ethics The study was approved by the regional ethics committee and performed in accordance with the Helsinki declaration. Each participant provided informed consent for participation in the study.
RESULTS Four hundred nine individuals (95%) returned the questionnaire they received 14 days after the examination. Thirty-nine questionnaires (10%) were returned with no specification of gender. The mediGASTROINTESTINAL ENDOSCOPY
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Table 3. How the endoscopic screening examination was assessed by the attendees 14 days after the procedure All participants (n = 409) Men (n = 195) Women (n = 175) Gender not stated (n = 39) With polyps removed (n = 294) Without polyps removed (n = 96) Polyp status not stated (n = 19) Original screening group (n = 196) Original control group (n = 212) Group not stated (n = 1) Attending colonoscopy (n = 373) Attending sigmoidoscopy (n = 27)
Very uncomfortable
Moderately uncomfortable
21 (5) 10 (5) 8 (5) 3 (8) 17 (6) 4 (4) 0 10 (5) 11 (5)
184 (45) 69 (35) 102 (58) 13 (33) 135 (46) 40 (42) 9 (47) 89 (45) 94 (44) 1 166 (45) 15 (56)
18 (5) 2 (7)
Not uncomfortable 204 116 65 23 142 52 10 97 107
(50) (59) (37) (59) (48) (52) (53) (50) (51)
189 (51) 10 (37)
Participants are divided into subgroups depending on gender, whether polyps were removed at the examination, whether the patient belonged to the original screening or control group, and whether colonoscopy or sigmoidoscopy was performed. Numbers represent individuals (percent).
an age was 67 years (range 63 to 72). Among the participants who had marked their gender on the questionnaire, 175 (47%) were women. Three hundred seventy-three (91%) had undergone a colonoscopy and 27 (7%) sigmoidoscopy. Nine individuals (2%) had not indicated on the questionnaire whether they had undergone sigmoidoscopy or colonoscopy. A total of 21 individuals (5%) found the examination very uncomfortable, 184 (45%) found it moderately uncomfortable, and 204 (50%) found the examination not uncomfortable (Table 3). Gender and discomfort The same proportion of men and women found the examination very uncomfortable (Table 3). When comparing the proportion of participants who found the examination very and moderately uncomfortable, 79 men (41%) and 110 women (63%), with the proportion of participants who found the examination not uncomfortable, 116 men (59%) and 65 women (37%), the relative risk (RR) of experiencing the examination as uncomfortable for women versus men was 1.6 (95% CI [1.3, 2.0], p < 0.001). Polyp removal and discomfort One hundred fifty-two (52%) of those who had polyps removed and 44 (46%) of those who did not have polyps removed found the examination uncomfortable (Table 3). This gives an RR of 1.1 (95% CI [0.9, 1.4], p = 0.3) for experiencing the examination as uncomfortable when polyps were removed compared with examinations in which polyps were not removed. Discomfort and previous colonoscopy There was no difference in how the examination was experienced between the original screening 608
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group who earlier had been subjected to one or more study lower endoscopies, and the control group where 48 (12%) had had a previous non-study lower endoscopy (Table 3). One individual had removed the marking that indicated which group he or she belonged to. Discomfort at sigmoidoscopy versus colonoscopy One hundred eighty-four (49%) individuals who underwent colonoscopy found the examination uncomfortable, whereas 17 (63%) who had sigmoidoscopy found the examination uncomfortable (Table 3). This gives an RR of 1.3 (95% CI [0.8, 1.7], p = 0.2) for experiencing the examination as uncomfortable when choosing sigmoidoscopy compared with colonoscopy. Willingness to repeat the examination in 5 years Three hundred sixty-eight individuals (90%) stated that they would undergo and 9 (2%) stated they would not undergo another examination in 5 years. Of these 9 individuals, 8 found the examination uncomfortable (4 found it very uncomfortable). Of those who stated they would undergo a new examination, 162 (46%) experienced the examination as uncomfortable, giving an RR of 1.9 (95% CI [1.1, 2.2], p = 0.02) for turning down an offer of a repeat examination if the examination was experienced as uncomfortable. Results at 3 months and 17 months At 3 and 17 months after the examination, 395 (92%) and 389 (91%) individuals, respectively, returned their questionnaires. Twenty-one (5%) and 20 (5%) stated at 3 and 17 months, respectively, that the examination was very uncomfortable; 172 (44%) and 173 (44%), respectively, evaluated the examination as moderately uncomfortable. VOLUME 52, NO. 5, 2000
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DISCUSSION Despite undergoing procedures without conscious sedation, 95% of study participants assessed the examination as not uncomfortable or only moderately uncomfortable, and 90% stated that they would undergo another examination in 5 years. In other studies, 4% to 20% of patients undergoing lower endoscopies without conscious sedation have reported severe pain.7,10,11 Our results are not directly comparable with those of the aforementioned studies. We used the term “uncomfortable” rather than “pain” in the questionnaire, and our data were not obtained immediately after the examination but about 14 days later. This time frame was used because of a concern that responses obtained immediately or shortly after a procedure would be too strongly influenced by the immediate relief after a successful examination with no significant pathologic condition detected. Hoffman et al.11 found no difference in the perception of pain during the procedure when assessed immediately after the examination and 2 to 5 days later. The responses provided by participants in the present study at 3 and 17 months after the examination were similar to those given 14 days after the examination. Thus, it appears that the perception of discomfort during the examination is little influenced by time. Other investigators have found that patients younger than our study participants tolerate endoscopic procedures less well.10,12 More individuals assessing the examination as uncomfortable might have been found if younger individuals had been included in our study. The narrow age range (63 to 72 years) prevents further analysis of this relationship using data from our study. Women found the examination more uncomfortable then men. Other investigators have obtained the same result,6,10,12 and it has been postulated that this might be due to a more tortuous sigmoid colon in women. Previous gynecologic operations such as hysterectomy with development of sigmoid colon adhesions may also contribute to the increased perception of pain in women.10 The attendance rate for the screening examination was 71%. It has been shown that people who comply with screening examinations are a selected group within the population.13-15 Those who do not accept screening examinations might have higher anxiety levels and therefore a lower tolerance for endoscopic procedures.12,16 Similar to previous findings,6 there was no correlation between tolerance and a previous lower endoscopy. The cecum was intubated in 86% of participants who presented for colonoscopy. This is less than that VOLUME 52, NO. 5, 2000
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reported in some studies in which patient tolerance was evaluated and where a 94% to 97% success rate for intubating to the cecum has been achieved.7,11,17 Reports of other studies have not included the success rate, which makes it difficult to evaluate the results.6,10,12 If we had pushed on to achieve a higher success rate, the proportion of individuals who experienced the examination as uncomfortable would certainly have been higher. For example, if we had pushed on to achieve a 95% success rate instead of 85% and if all these additional patients in whom the cecum was successfully intubated gave reports of severe discomfort, the total proportion of individuals experiencing severe discomfort could have been as high as 15%. It might be considered as less important to intubate the cecum in a screening setting compared with an examination performed because of symptoms that raised a suspicion of colorectal cancer. The experience of pain and discomfort will affect compliance for screening and surveillance, and the endoscopist might therefore be more inclined to discontinue what is causing discomfort in an asymptomatic participant. Pain and discomfort experienced by patients during colonoscopy also depend on the skill and technique of the endoscopist.10 The results of our study are based on examinations performed by a single endoscopist. The percentage of individuals who experienced the examination as uncomfortable, among those who underwent a sigmoidoscopy compared with those attending for colonoscopy, was somewhat higher, though not statistically significant. The sigmoidoscopy group had, however, a high degree of self-selection bias as it consisted of individuals who rejected the recommendation to choose colonoscopy. The intravenous administration of sedative drugs at colonoscopy seems to be dependent on cultural factors18; few hard data exist to justify their use. For example, the routine use of conscious sedation at barium enemas has never been suggested even though Eckhardt et al.19 have shown that there is no difference in procedure-related discomfort between colonoscopy and barium enema. Ristikankare et al.20 did not find any marked increase in patient tolerance with the use of conscious sedation. The administration of sedative drugs to individuals only when, and if, they experience pain during the examination may be a practical approach to this issue.21 This would combine the positive effects of sedation and reduce the rate of sedation-induced complications.22 In conclusion, the routine administration of sedative drugs did not seem to be necessary in a setting of colonoscopic screening for colorectal polyps among individuals from a normal population in the GASTROINTESTINAL ENDOSCOPY
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age group 63 to 72 years. The lack of conscious sedation may, however, increase the duration of the procedure and reduce the proportion of participants in whom the cecum is visualized, and some adenomas and cancers might therefore be missed. This has to be weighed against the increase in cost of screening, increase in complications, and longer recovery period for patients associated with conscious sedation. REFERENCES 1. Daneshmend TK, Bell GD, Logan RFA. Sedation for upper gastrointestinal endoscopy: results of a nationwide survey. Gut 1991;32:12-5. 2. Keeffe EB, O’Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc 1990;36:S13-8. 3. Quine MA, Bell GD, McCloy RF, Charlton JE, Devlin HB, Hopkins A. Prospective audit of upper gastrointestinal endoscopy in two regions of England: safety, staffing, and sedation methods. Gut 1995;36:462-7. 4. Hart R, Classen M. Complications of diagnostic gastrointestinal endoscopy. Endoscopy 1990;22:229-33. 5. Arrowsmith JB, Gerstman BB, Fleischer DE, Benjamin SB. Results from the American Society for Gastrointestinal endoscopy/ U.S. Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy. Gastrointest Endosc 1991;37:421-7. 6. Froehlich F, Thorens J, Schwizer W, Preisig M, Köhler M, Hays RD, et al. Sedation and analgesia for colonoscopy: patient tolerance, pain, and cardiorespiratory parameters. Gastrointest Endosc 1997;45:1-9. 7. Cataldo PA. Colonoscopy without sedation. A viable alternative. Dis Colon Rectum 1996;39:257-61. 8. Thiis-Evensen E, Hoff GS, Sauar J, Langmark F, Majak MB, Vatn MH. Population-based surveillance by colonoscopy: Effect on the incidence of colorectal cancer. Telemark polyp study I. Scand J Gastroenterol 1999;34:414-20. 9. Thiis-Evensen E, Wilhelmsen I, Hoff SG, Blomhoff S, Sauar J. The psychologic effect of attending a screening program for colorectal cancer. Scand J Gastroenterol 1999;34:103-9.
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10. Hull T, Church JM. Colonoscopy-how difficult, how painful? Surg Endosc 1994;8:784-87. 11. Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol 1998;26:279-82. 12. Martin JP, Arlett PA, Holdstock G. Development of a sedation policy for upper GI endoscopy based on an audit of patients’ perception of the procedure. Eur J Gastroenterol Hepatol 1996;8:355-7. 13. MacLean U, Sinfield D, Klein S, Harnden B. Women who decline breast screening. J Epidemiol Community Health 1984;38:278-83. 14. Hayward RA, Shapiro MF, Freeman HE, Corey CR. Who gets screened for cervical and breast cancer? Results from a new national survey. Arch Intern Med 1988;148:1177-81. 15. Farrands PA, Hardcastle JD, Chamberlain J, Moss S. Factors affecting compliance with screening for colorectal cancer. Community Med 1984;6:12-9. 16. Preisig M, Froehlich F, Thorens J, Schwizer W, Gonvers JJ. Impact of anxiety and personality on tolerance and pain during colonoscopy [abstract]. Gastrointest Endosc 1997;45:AB55. 17. Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc 1999;49:554-9. 18. Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol 1999;94:1862-5. 19. Eckardt VF, Kanzler G, Willems D, Eckardt AJ, Bernhard G. Colonoscopy without premedication versus barium enema: a comparison of patient discomfort. Gastrointest Endoscopy 1996;44:177-80. 20. Ristikankare M, Hartikainen J, Heikkinen M, Janatuinen E, Julkunen R. Is routinely given conscious sedation of benefit during colonoscopy? Gastrointest Endosc 1999;49:566-72. 21. Stermer E, Gaitini L, Yudashkin M, Essaian G, Tamir A. Patient-controlled analgesia for conscious sedation during colonoscopy: a randomized controlled study. Gastrointest Endosc 2000;51:278-81. 22. Eckardt VF, Kanzler G, Schmitt T, Eckardt AJ, Bernhard G. Complications and adverse effects of colonoscopy with selective sedation. Gastrointest Endosc 1999;49:560-5.
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