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Su1690 Sitting Versus Standing Posture of Operator in Performing Colonoscopy: a Randomized Controlled Open-Label Trial
Abstracts Table 1. Patients’ tolerance and sedation, analysis includes only cases without change in method WE, n[371
WI, n[338
AI-CO2, n[382
Painless unsedated colonoscopy, ** n (%)
50 (13.5)
26 (7.7)
23 (6.0)
Completed without sedation, n (%)
321 (86.5)
287 (84.9)
292 (76.4)
Unsedated, completed with only discomfort, ** n (%)
134 (36.1)
106 (31.4)
87 (22.8)
P value* WE vs WI 0.013* WE vs AI !0.0005* WI vs AI 0.374* WE vs WI 0.537* WE vs AI !0.0005* WI vs AI 0.004* WE vs WI 0.180* WE vs AI !0.0005* WI vs AI 0.009*
cally significant (pZ0.86). Change of patient’s posture was also not significantly different in both the groups with 26 (7.1%) and 7 (5.7%) patients required change in posture in sitting and standing group respectively (pZ0.57). No complications were observed except mild to moderate post procedural abdominal pain in 19 (5.2%) and 6(4.8%) patients in the sitting and standing group respectively. This did not require any interventions. Conclusion: Performing colonoscopy in operator’s sitting posture is as efficacious and safe as in operator’s standing posture with formerly being associated with added comfort of sitting.
See legend at foot of Table 2.
Table 2. Variations among investigators. Procedural data: WE group Insertion pain, ** mean (95% CI) AI-
Insertion time,
Abdominal compression
Previous surgery
Loop reduction
Females
BMI
CO2
min (SD)
(%)
(%)
(%)
(%)
(SD)
13 (6.5)
57.5
51.3
61.3
46.3
26.1 (4.9)
11 (5.5)
67.1
46.8
63.3
32.9
27.0 (4.8)
11 (4.4)
57.1
7.1
7.1
28.6
27.5 (4.4)
15 (6.7)
71.4
10.7
21.4
28.6
25.6 (4.2)
3.5 (2.24.8)
9 (2.8)
92.3
7.7
84.6
46.2
24.6 (3.3)
2.6 (1.53.7)
3.5 (2.54.5)
10 (4.0)
73.9
13.0
52.2
60.9
28.4 (6.8)
2.4 (1.63.2) 2.8 (2.0-
3.7 (2.35.1) 2.4 (1.7-
4.3 (3.05.6) 2.4 (1.4-
12 (7.2)
64.7
41.2
82.4
17.6
26.4 (2.5)
15 (5.2)
92.9
35.7
92.9
50.0
25.6 (4.0)
9
3.6) 2.9 (2.3-
3.0) 4.1 (3.4-
3.3) 6.0 (5.3-
9 (3.1)
36.1
45.9
34.4
37.7
28.4 (5.2)
10
3.5) 5.3 (4.4-
4.9) 7.1 (6.3-
6.7) 7.0 6.2-7.9)
8 (3.0)
21.4
35.7
10.7
50.0
27.2 (5.6)
6.2)
8.0) PZ0.074s
PZ0.025s
Investigator
WE
WI
1
2.1 (1.7-
4.0 (3.4-
4.7 (4.1-
2
2.5) 2.9 (2.4-
4.7) 3.3 (2.8-
5.3) 4.1 (3.5-
3.3) 2.3 (1.03.6)
3.9) 2.3 (1.03.6)
4.7) 4 (2.9-5.2)
4
2.4 (1.73.2)
1.9 (0.63.3)
2.8 (2.03.5)
5
2.9 (1.84.0)
3.7 (2.35.1)
6
2.4 (1.63.3)
7 8
3
P values: all !0.0005s
In all tables: n, number of patients; WE (AI-CO2), water exchange for insertion, insufflation with air or CO2 for withdrawal; WI (AI-CO2), water immersion for insertion, insufflation with air or CO2 for withdrawal; AI-CO2, insufflation with air or CO2 for insertion and withdrawal. * Chi squared; s ANOVA; ** Pain score based on numeric rating scale (NRS): 0Zabsence of pain, 1-2Zdiscomfort, 10Zmaximum pain; CI; confidence interval; SD, standard deviation.
Su1690 Sitting Versus Standing Posture of Operator in Performing Colonoscopy: a Randomized Controlled Open-Label Trial Mahesh Goenka, Vijay K. Rai*, Usha Goenka Apollo Gleneagles Hospitals, Kolkata, India Background: Operator’s standing posture is the conventional posture of performing colonoscopy. Till date, there had been no known randomized controlled trial about the efficacy and feasibility of performing colonoscopy by the operator in sitting posture as compared to standing posture. Aim: Impact of the operator’s posture (sitting vs. standing) on success rate of colonoscopy. Methods: Prospectively all outpatients referred for colonoscopy and satisfying predefined inclusion criteria, underwent 3:1 randomization to undergo colonoscopy either in operator’s sitting or standing posture. After informed consent, colonoscopy (160 series, Olympus) was carried out following overnight sodium phosphate based preparation. Colonoscopy was performed under conscious sedation with intravenous midazolam and continuous pulse-oxymetry monitoring. All colonoscopies were performed by single senior endoscopist who was assisted by experienced nurse in pushing, withdrawing and delooping the colonoscope, at outpatient gastrointestinal center attached to tertiary hospital. Boston Bowel Preparation Scale (BBPS) was used for assessment of adequacy of bowel preparation. Appropriate statistical analysis was performed with Pearson’s Chi-square test and Independent sample t test. A p value of !0.05 was considered significant. Results: 507 patients were randomized, 378 in the operator’s sitting posture group and 129 in the standing posture group. There was no difference in the baseline characteristics between the two groups. Cecum was not reached in 15/378 patients in the sitting group and 6/129 patients in the standing group which was not statistically significant. Sitting group had failed cecal intubation due to procedural difficulty in 7 patients whereas 2 patients had procedural difficulty in standing group. Patients from both the groups, who had failed cecal intubations were excluded from final analysis. The cecal intubation time was 153 75.6 sec (mean standard deviation) in the sitting group and 154.9 100.8 sec (mean standard deviation) in the standing group which was not statistically significant (pZ0.894). Manual abdominal compression was used in 162 (44.6%) patients in sitting group and 56 (45.5%) patients in the standing group which was not statisti-
AB380 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1691 Effectiveness and Safety of a New Insufflation-Less Method for Colonoscopy Michael V. Chiorean*, Johannes Koch, Richard A. Kozarek, Danielle La Selva Gastroenterology, Virginia Mason Medical Center, Seattle, WA Background: Minimizing colon distention during insertion can facilitate cecal intubation and improve patient tolerance during colonoscopy. The aim of this study was to evaluate the utility of a balloon-catheter (VizballoonÒ, VB) positioned like a dome in front of the scope and that allows scope insertion without gas distention. Methods: Patients referred for colonoscopy at a single center were prospectively enrolled. Two experienced endoscopists performed all procedures under moderate sedation. Patients with colon surgery or active IBD were excluded. The outcomes of interest, cecal intubation rate, time to cecum and sedation dose were compared between the VB and a control group of patients who underwent standard colonoscopy matched for calendar year, gender, age and endoscopist. Categorical variables were analyzed using the chi-square test and continuous variables using the t-test. Results: Overall 86 patients underwent VB-assisted colonoscopy (43% male, mean age 59.0, 87% screening or surveillance). Cecal intubation was achieved in 100% in the VB group by intent-to-treat and 83.7% per protocol (VB maintained to the cecum) and 99% of standard colonoscopy group. VB failures to reach the cecum were attributed to visual difficulties in 15.1% and technical issues in 18.6%. Cecal intubation time was 6.92.86 min in the VB group vs 6.32.8 min in the control group (pZ0.13). There was no significant difference in the sedation requirements between the two groups (pZ0.16). The procedures were tolerated well by 89.5% of the patients and there were no complications in either group. The operator perceived gas-less intubation as same or easier in 80.2% and more difficult in 19.8%. VB was considered helpful in 82.5% vs. hindering in 17.5% and the endoscopist was willing to reuse it in 65% of cases but with significant heterogeneity between the operators (pZ0.01, pZ0.0003, pZ0.0064). Conclusions: Overall insufflation-less colonoscopy using a balloon catheter does not appear to improve intubation rate or time and patient tolerance of the procedure. However, this study cannot rule out that the device may be helpful in a subgroup of patients referred for colonoscopy.
Su1692 Safety and Efficacy of a Novel Balloon System for Difficult Colonoscopy Helmut Neumann*1, Timo Rath1, Andreas Naegel1, Markus F. Neurath1, Michael Vieth3, Klaus Monkemuller2 1 Department of Medicine 1, University of Erlangen-Nuremberg, Erlangen, Germany; 2Basil Hirschowitz Endoscopic Center of Excellence, University of Alabama at Birmingham, Birmingham, Germany; 3Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany Introduction: Colonoscopy is the gold standard for colorectal cancer screening. However, total colonoscopy may be impeded by several factors, including extensive diverticulosis, elongated transverse colon, female gender, low body mass index, or prior abdominal or pelvic surgery. Aims: We aimed to establish the safety and efficacy of a novel balloon system which will be officially introduced at DDW 2015 for difficult colonoscopy. Material & Methods: Patients (mean age 75 years; Range 21-78 years; 40% female) referred for colonoscopy after failure of previous colonoscopy were prospectively enrolled in a pilot cohort study whose primary end point was device safety. Other study endpoints included success rate and time of cecum intubation, withdrawal times, total procedure times, and success of therapeutic procedures. Results: Among the enrolled patients one was excluded due to a technical problem of the device. Ileocolonoscopy was performed in all (100%) patients using the novel balloon-system without any complications. Cecal intubation rate was 100%. Mean times to reach the cecum, withdrawal, and total procedure times were 11.05 minutes, 15 minutes, and 32 minutes, respectively. All therapeutic endoscopic
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WI, n[338
AI-CO2, n[382
Painless unsedated colonoscopy, ** n (%)
50 (13.5)
26 (7.7)
23 (6.0)
Completed without sedation, n (%)
321 (86.5)
287 (84.9)
292 (76.4)
Unsedated, completed with only discomfort, ** n (%)
134 (36.1)
106 (31.4)
87 (22.8)
P value* WE vs WI 0.013* WE vs AI !0.0005* WI vs AI 0.374* WE vs WI 0.537* WE vs AI !0.0005* WI vs AI 0.004* WE vs WI 0.180* WE vs AI !0.0005* WI vs AI 0.009*
cally significant (pZ0.86). Change of patient’s posture was also not significantly different in both the groups with 26 (7.1%) and 7 (5.7%) patients required change in posture in sitting and standing group respectively (pZ0.57). No complications were observed except mild to moderate post procedural abdominal pain in 19 (5.2%) and 6(4.8%) patients in the sitting and standing group respectively. This did not require any interventions. Conclusion: Performing colonoscopy in operator’s sitting posture is as efficacious and safe as in operator’s standing posture with formerly being associated with added comfort of sitting.
See legend at foot of Table 2.
Table 2. Variations among investigators. Procedural data: WE group Insertion pain, ** mean (95% CI) AI-
Insertion time,
Abdominal compression
Previous surgery
Loop reduction
Females
BMI
CO2
min (SD)
(%)
(%)
(%)
(%)
(SD)
13 (6.5)
57.5
51.3
61.3
46.3
26.1 (4.9)
11 (5.5)
67.1
46.8
63.3
32.9
27.0 (4.8)
11 (4.4)
57.1
7.1
7.1
28.6
27.5 (4.4)
15 (6.7)
71.4
10.7
21.4
28.6
25.6 (4.2)
3.5 (2.24.8)
9 (2.8)
92.3
7.7
84.6
46.2
24.6 (3.3)
2.6 (1.53.7)
3.5 (2.54.5)
10 (4.0)
73.9
13.0
52.2
60.9
28.4 (6.8)
2.4 (1.63.2) 2.8 (2.0-
3.7 (2.35.1) 2.4 (1.7-
4.3 (3.05.6) 2.4 (1.4-
12 (7.2)
64.7
41.2
82.4
17.6
26.4 (2.5)
15 (5.2)
92.9
35.7
92.9
50.0
25.6 (4.0)
9
3.6) 2.9 (2.3-
3.0) 4.1 (3.4-
3.3) 6.0 (5.3-
9 (3.1)
36.1
45.9
34.4
37.7
28.4 (5.2)
10
3.5) 5.3 (4.4-
4.9) 7.1 (6.3-
6.7) 7.0 6.2-7.9)
8 (3.0)
21.4
35.7
10.7
50.0
27.2 (5.6)
6.2)
8.0) PZ0.074s
PZ0.025s
Investigator
WE
WI
1
2.1 (1.7-
4.0 (3.4-
4.7 (4.1-
2
2.5) 2.9 (2.4-
4.7) 3.3 (2.8-
5.3) 4.1 (3.5-
3.3) 2.3 (1.03.6)
3.9) 2.3 (1.03.6)
4.7) 4 (2.9-5.2)
4
2.4 (1.73.2)
1.9 (0.63.3)
2.8 (2.03.5)
5
2.9 (1.84.0)
3.7 (2.35.1)
6
2.4 (1.63.3)
7 8
3
P values: all !0.0005s
In all tables: n, number of patients; WE (AI-CO2), water exchange for insertion, insufflation with air or CO2 for withdrawal; WI (AI-CO2), water immersion for insertion, insufflation with air or CO2 for withdrawal; AI-CO2, insufflation with air or CO2 for insertion and withdrawal. * Chi squared; s ANOVA; ** Pain score based on numeric rating scale (NRS): 0Zabsence of pain, 1-2Zdiscomfort, 10Zmaximum pain; CI; confidence interval; SD, standard deviation.
Su1690 Sitting Versus Standing Posture of Operator in Performing Colonoscopy: a Randomized Controlled Open-Label Trial Mahesh Goenka, Vijay K. Rai*, Usha Goenka Apollo Gleneagles Hospitals, Kolkata, India Background: Operator’s standing posture is the conventional posture of performing colonoscopy. Till date, there had been no known randomized controlled trial about the efficacy and feasibility of performing colonoscopy by the operator in sitting posture as compared to standing posture. Aim: Impact of the operator’s posture (sitting vs. standing) on success rate of colonoscopy. Methods: Prospectively all outpatients referred for colonoscopy and satisfying predefined inclusion criteria, underwent 3:1 randomization to undergo colonoscopy either in operator’s sitting or standing posture. After informed consent, colonoscopy (160 series, Olympus) was carried out following overnight sodium phosphate based preparation. Colonoscopy was performed under conscious sedation with intravenous midazolam and continuous pulse-oxymetry monitoring. All colonoscopies were performed by single senior endoscopist who was assisted by experienced nurse in pushing, withdrawing and delooping the colonoscope, at outpatient gastrointestinal center attached to tertiary hospital. Boston Bowel Preparation Scale (BBPS) was used for assessment of adequacy of bowel preparation. Appropriate statistical analysis was performed with Pearson’s Chi-square test and Independent sample t test. A p value of !0.05 was considered significant. Results: 507 patients were randomized, 378 in the operator’s sitting posture group and 129 in the standing posture group. There was no difference in the baseline characteristics between the two groups. Cecum was not reached in 15/378 patients in the sitting group and 6/129 patients in the standing group which was not statistically significant. Sitting group had failed cecal intubation due to procedural difficulty in 7 patients whereas 2 patients had procedural difficulty in standing group. Patients from both the groups, who had failed cecal intubations were excluded from final analysis. The cecal intubation time was 153 75.6 sec (mean standard deviation) in the sitting group and 154.9 100.8 sec (mean standard deviation) in the standing group which was not statistically significant (pZ0.894). Manual abdominal compression was used in 162 (44.6%) patients in sitting group and 56 (45.5%) patients in the standing group which was not statisti-
AB380 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
Su1691 Effectiveness and Safety of a New Insufflation-Less Method for Colonoscopy Michael V. Chiorean*, Johannes Koch, Richard A. Kozarek, Danielle La Selva Gastroenterology, Virginia Mason Medical Center, Seattle, WA Background: Minimizing colon distention during insertion can facilitate cecal intubation and improve patient tolerance during colonoscopy. The aim of this study was to evaluate the utility of a balloon-catheter (VizballoonÒ, VB) positioned like a dome in front of the scope and that allows scope insertion without gas distention. Methods: Patients referred for colonoscopy at a single center were prospectively enrolled. Two experienced endoscopists performed all procedures under moderate sedation. Patients with colon surgery or active IBD were excluded. The outcomes of interest, cecal intubation rate, time to cecum and sedation dose were compared between the VB and a control group of patients who underwent standard colonoscopy matched for calendar year, gender, age and endoscopist. Categorical variables were analyzed using the chi-square test and continuous variables using the t-test. Results: Overall 86 patients underwent VB-assisted colonoscopy (43% male, mean age 59.0, 87% screening or surveillance). Cecal intubation was achieved in 100% in the VB group by intent-to-treat and 83.7% per protocol (VB maintained to the cecum) and 99% of standard colonoscopy group. VB failures to reach the cecum were attributed to visual difficulties in 15.1% and technical issues in 18.6%. Cecal intubation time was 6.92.86 min in the VB group vs 6.32.8 min in the control group (pZ0.13). There was no significant difference in the sedation requirements between the two groups (pZ0.16). The procedures were tolerated well by 89.5% of the patients and there were no complications in either group. The operator perceived gas-less intubation as same or easier in 80.2% and more difficult in 19.8%. VB was considered helpful in 82.5% vs. hindering in 17.5% and the endoscopist was willing to reuse it in 65% of cases but with significant heterogeneity between the operators (pZ0.01, pZ0.0003, pZ0.0064). Conclusions: Overall insufflation-less colonoscopy using a balloon catheter does not appear to improve intubation rate or time and patient tolerance of the procedure. However, this study cannot rule out that the device may be helpful in a subgroup of patients referred for colonoscopy.
Su1692 Safety and Efficacy of a Novel Balloon System for Difficult Colonoscopy Helmut Neumann*1, Timo Rath1, Andreas Naegel1, Markus F. Neurath1, Michael Vieth3, Klaus Monkemuller2 1 Department of Medicine 1, University of Erlangen-Nuremberg, Erlangen, Germany; 2Basil Hirschowitz Endoscopic Center of Excellence, University of Alabama at Birmingham, Birmingham, Germany; 3Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany Introduction: Colonoscopy is the gold standard for colorectal cancer screening. However, total colonoscopy may be impeded by several factors, including extensive diverticulosis, elongated transverse colon, female gender, low body mass index, or prior abdominal or pelvic surgery. Aims: We aimed to establish the safety and efficacy of a novel balloon system which will be officially introduced at DDW 2015 for difficult colonoscopy. Material & Methods: Patients (mean age 75 years; Range 21-78 years; 40% female) referred for colonoscopy after failure of previous colonoscopy were prospectively enrolled in a pilot cohort study whose primary end point was device safety. Other study endpoints included success rate and time of cecum intubation, withdrawal times, total procedure times, and success of therapeutic procedures. Results: Among the enrolled patients one was excluded due to a technical problem of the device. Ileocolonoscopy was performed in all (100%) patients using the novel balloon-system without any complications. Cecal intubation rate was 100%. Mean times to reach the cecum, withdrawal, and total procedure times were 11.05 minutes, 15 minutes, and 32 minutes, respectively. All therapeutic endoscopic
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