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Tu1062 Cost-Effectiveness of Stapled Hemorrhoidopexy: A Randomized Comparison With Ferguson Closed Diathermy Hemorrhoidectomy
decrease health-care utilization among functional GI patients. Future research should examine barriers to participating in this line of treatment. Tu1062
AGA Abstracts
Cost-Effectiveness of Stapled Hemorrhoidopexy: A Randomized Comparison With Ferguson Closed Diathermy Hemorrhoidectomy Mohamed A. Thaha, Kenneth Campbell, Catherine Bryant, Syed Kazmi, Norman Binnie, Wilson Hendry, Andrew Walker, Robert J. Steele Background: Our 2-armed multi-centre randomized controlled trial (RCT) reported a significantly reduced postoperative pain and higher patient acceptability following stapled hemorrhoidopexy (SH) but without similar advantage for post-treatment residual prolapse or retreatment rates. In this parallel health economics study, we aimed to determine the costeffectiveness of SH from a hospital perspective when compared with Ferguson hemorrhoidectomy (FH). Methods: After informed consent and randomization, 182-patients with symptomatic hemorrhoids (grades II, III, IV) underwent either SH (91) or FH and were followed for up to 1-year (6, 12, 24, 48-weeks) after operation. All health-care resource costs for the initial treatment and follow-up events were recorded prospectively at individual patient level. Quality of life (QoL) was assessed at baseline, and at follow-up using SF36v2 questionnaire and QALY's generated using SF-6D algorithm. An incremental cost of avoiding a recurrence was calculated along with an incremental cost per QALY for SH. Differences between groups were based on linear regression adjusting for baseline scores. Results: At 1-year follow-up, a total of 18 (20.7%) patients in SH group had clinical recurrence compared to 9 (11.5%) in FH group (OR= 2, 95% CI 0.8405-4.7593). 12-SH patients required retreatment for residual symptoms compared to 5 in FH group. Re-treatment for residual prolapse was significantly higher in SH group (8 vs. 1; SH vs. FH; p=0.027 X2-test). At 1year the mean difference in QALY's was non-significant (0.7877 vs. 0.7938, SH vs. FH; p= 0.877 MWU-test). The extra mean cost (£312.51) incurred for SH was due to the additional cost for the single use custom-designed circular stapler. The cost per unit of successful outcome was less in FH group compared to SH group (£770.75 vs. 1184.45; FH vs. SH). Conclusions: Stapled hemorrhoidopexy offers significant advantages of lower post-operative pain but is associated with significantly higher residual prolapse rates requiring re-operation. The mean cost of stapled hemorrhoidopexy was higher compared to Ferguson hemorrhoidectomy and this was largely explained by the cost of the single use stapler. Furthermore, the study failed to demonstrate any significant cost-effectiveness advantage for stapled hemorrhoidopexy when compared to Ferguson hemorrhoidectomy.
*: SF-12 and EuroQoL: higher score indicates better health; Generic and Screen-specific anxiety: higher score indicates more anxiety a,b: A significant difference between FIT responders (negative/positive result) resp. FS responders (negative/positive result)
Tu1063 Tu1064 Quality of Life in Participants of a CRC Screening Program Atija Kapidzic, Ida J. Korfage, Leonie van Dam, Aafke H. van Roon, Jacqueline C. Reijerink, Marjolein van Ballegooijen, Ernst J. Kuipers, Monique van Leerdam
Role of Clopidogrel and Rabeprazole in Low-Dose Aspirin-Induced Gastric Mucosal Injury in Relation to CYP2C19 Genotype Takahiro Uotani, Mitsushige Sugimoto, Masafumi Nishino, Chise Kodaira, Mihoko Yamade, Shu Sahara, Takanori Yamada, Satoshi Osawa, Ken Sugimoto, Takahisa Furuta
Background: Little is known on the effect of participating in a CRC screening program on quality of life (QOL), neither for participants with a negative test result nor for those with a positive test result. These findings however, are important to evaluate the burden of CRC screening, so costs and benefits of a CRC screening program can be reliably estimated. Methods: Participants from CRC screening trials (CORERO-I and -II) were sent a questionnaire, which included validated measures on generic health-related QOL (12-item ShortForm Health Survey (SF-12) on physical and mental health, and EuroQol classification (EQ5D)), generic anxiety (State Trait Anxiety Inventory (STAI-6)), and screen-specific anxiety (Psychological Consequences Questionnaire (PCQ)). Both fecal immunochemical test (FIT) and flexible sigmoidoscopy (FS) participants, either with negative or positive test results, were addressed. Results: In total, 664/915 (73%) participants with a negative FIT result (46.5% males; mean age 63.0 years), and 625/857 (73%) participants with a positive FIT result (60.8% males; mean age 65.5 years) returned the questionnaire. In FS participants, response rates were 75% (349/462) among those with a negative result (57.3% males; mean age 63.9 years) and 82% (187/222) among participants with a positive result (64.2% males; mean age 66.1 years). On the whole, FIT participants with a positive test result had worse QOL scores than participants with a negative test result (Table 1). Positive FIT participants had worse physical (PCS-12, FIT 47.1 vs. 48.3, p=0.02) and slightly worse mental QOL scores (MCS-12, FIT 51.1 vs. 51.6, p=0.26) than participants with a negative result (a higher score indicates better health). Furthermore, QOL scores were similar in positive FIT participants with either a negative or a positive colonoscopy. Positive FS participants tended to have worse QOL scores than negative participants, but these differences were not statistically significant. Conclusion: No significant differences existed in QOL scores between FS participants in this CRC screening program. Participants with a positive FIT had slightly worse QOL scores than participants with a negative screening test. However, these differences were small, and not clinically relevant. These findings may indicate that the burden of participating in CRC screening is limited. Conducting a prospective study to confirm these results is recommended. Scores of responders with a negative and a positive screening test
Background: While the use of anti-platelet agents such as low-dose aspirin (LDA) and clopidogrel in primary and secondary prophylaxis against cardiovascular and cerebrovascular diseases is increasing, LDA often causes not only gastric mucosal injury but also esophageal and small bowel mucosal injury, even at low doses and in enteric-coated form. However, clopidogrel generally carries a lower risk than LDA for inducing gastric mucosal injury. Given the uncertainty as to whether or not clopidogrel exacerbates LDA-induced gastric mucosal injury, we attempted to discern whether or not clopidogrel induced gastric mucosal injury and if PPI administration improved gastric mucosal injury inflicted by dual therapy with LDA + clopidogrel (Study 1). Further, we also examined whether or not extent of gastric mucosal injury by dual therapy depended on CYP2C19 genotype status (Study 2). Methods: In Study 1, ten subjects with different CYP2C19 genotypes received four randomized cross-over regimens (seven days each): LDA (100 mg; A), clopidogrel (75 mg; C), LDA and clopidogrel (AC), and LDA, clopidogrel, and rabeprazole (10 mg) (ACR). In Study 2, 30 subjects received the AC regimen for 7 days. On Days 3 and 7 of each regimen, gastroduodenoscopy was performed to assess extent of gastric mucosal injury based on the modified LANZA score (MLS), and an anti-platelet function test was conducted. We also determined the effects of the above drugs on 24-h intragastric pH values on Day 7. Results: Significant increases in extent of gastric mucosal injury on Day 3 and 7 were observed in not only regimens A (median MLS ranges: 1.7 [0-3.7] and 2.2 [0.0-5.0]) and AC (1.7 [04.0] and 2.5 [0.33-4.0]), but also regimen C (1.5 [0-3.0] and 0.33 [0.0-2.67]). However, the median MLS in regimen A was almost the same as that in regimen AC. Extent of gastric mucosal injury, 24-h intragastric pH, and anti-platelet effect differed by CYP2C19 genotype in the ACR regimen. Although the ACR regimen effectively inhibited gastric mucosal injury, the mean MLS in CYP2C19 rapid metabolizers was significantly higher than in intermediate or poor metabolizers (p = 0.028) due to insufficient acid inhibition (24-h pH p = 0.023). No effects on anti-platelet effect or intragastric pH could be attributed to interaction between rabeprazole and clopidogrel. Conclusions: The extent of gastric mucosal injury caused by clopidogrel was similar to that caused by LDA, particularly in the early phase of administration. However, clopidogrel did not exacerbate LDA-induced gastric mucosal injury, regardless of CYP2C19 genotype. Although rabeprazole effectively prevented both LDA- and clopidogrel-induced gastric mucosal injury without attenuating clopidogrel's anti-platelet function, its prophylactic effect on this gastric mucosal injury varied by CYP2C19 genotype.
S-735
AGA Abstracts
AGA Abstracts
Cost-Effectiveness of Stapled Hemorrhoidopexy: A Randomized Comparison With Ferguson Closed Diathermy Hemorrhoidectomy Mohamed A. Thaha, Kenneth Campbell, Catherine Bryant, Syed Kazmi, Norman Binnie, Wilson Hendry, Andrew Walker, Robert J. Steele Background: Our 2-armed multi-centre randomized controlled trial (RCT) reported a significantly reduced postoperative pain and higher patient acceptability following stapled hemorrhoidopexy (SH) but without similar advantage for post-treatment residual prolapse or retreatment rates. In this parallel health economics study, we aimed to determine the costeffectiveness of SH from a hospital perspective when compared with Ferguson hemorrhoidectomy (FH). Methods: After informed consent and randomization, 182-patients with symptomatic hemorrhoids (grades II, III, IV) underwent either SH (91) or FH and were followed for up to 1-year (6, 12, 24, 48-weeks) after operation. All health-care resource costs for the initial treatment and follow-up events were recorded prospectively at individual patient level. Quality of life (QoL) was assessed at baseline, and at follow-up using SF36v2 questionnaire and QALY's generated using SF-6D algorithm. An incremental cost of avoiding a recurrence was calculated along with an incremental cost per QALY for SH. Differences between groups were based on linear regression adjusting for baseline scores. Results: At 1-year follow-up, a total of 18 (20.7%) patients in SH group had clinical recurrence compared to 9 (11.5%) in FH group (OR= 2, 95% CI 0.8405-4.7593). 12-SH patients required retreatment for residual symptoms compared to 5 in FH group. Re-treatment for residual prolapse was significantly higher in SH group (8 vs. 1; SH vs. FH; p=0.027 X2-test). At 1year the mean difference in QALY's was non-significant (0.7877 vs. 0.7938, SH vs. FH; p= 0.877 MWU-test). The extra mean cost (£312.51) incurred for SH was due to the additional cost for the single use custom-designed circular stapler. The cost per unit of successful outcome was less in FH group compared to SH group (£770.75 vs. 1184.45; FH vs. SH). Conclusions: Stapled hemorrhoidopexy offers significant advantages of lower post-operative pain but is associated with significantly higher residual prolapse rates requiring re-operation. The mean cost of stapled hemorrhoidopexy was higher compared to Ferguson hemorrhoidectomy and this was largely explained by the cost of the single use stapler. Furthermore, the study failed to demonstrate any significant cost-effectiveness advantage for stapled hemorrhoidopexy when compared to Ferguson hemorrhoidectomy.
*: SF-12 and EuroQoL: higher score indicates better health; Generic and Screen-specific anxiety: higher score indicates more anxiety a,b: A significant difference between FIT responders (negative/positive result) resp. FS responders (negative/positive result)
Tu1063 Tu1064 Quality of Life in Participants of a CRC Screening Program Atija Kapidzic, Ida J. Korfage, Leonie van Dam, Aafke H. van Roon, Jacqueline C. Reijerink, Marjolein van Ballegooijen, Ernst J. Kuipers, Monique van Leerdam
Role of Clopidogrel and Rabeprazole in Low-Dose Aspirin-Induced Gastric Mucosal Injury in Relation to CYP2C19 Genotype Takahiro Uotani, Mitsushige Sugimoto, Masafumi Nishino, Chise Kodaira, Mihoko Yamade, Shu Sahara, Takanori Yamada, Satoshi Osawa, Ken Sugimoto, Takahisa Furuta
Background: Little is known on the effect of participating in a CRC screening program on quality of life (QOL), neither for participants with a negative test result nor for those with a positive test result. These findings however, are important to evaluate the burden of CRC screening, so costs and benefits of a CRC screening program can be reliably estimated. Methods: Participants from CRC screening trials (CORERO-I and -II) were sent a questionnaire, which included validated measures on generic health-related QOL (12-item ShortForm Health Survey (SF-12) on physical and mental health, and EuroQol classification (EQ5D)), generic anxiety (State Trait Anxiety Inventory (STAI-6)), and screen-specific anxiety (Psychological Consequences Questionnaire (PCQ)). Both fecal immunochemical test (FIT) and flexible sigmoidoscopy (FS) participants, either with negative or positive test results, were addressed. Results: In total, 664/915 (73%) participants with a negative FIT result (46.5% males; mean age 63.0 years), and 625/857 (73%) participants with a positive FIT result (60.8% males; mean age 65.5 years) returned the questionnaire. In FS participants, response rates were 75% (349/462) among those with a negative result (57.3% males; mean age 63.9 years) and 82% (187/222) among participants with a positive result (64.2% males; mean age 66.1 years). On the whole, FIT participants with a positive test result had worse QOL scores than participants with a negative test result (Table 1). Positive FIT participants had worse physical (PCS-12, FIT 47.1 vs. 48.3, p=0.02) and slightly worse mental QOL scores (MCS-12, FIT 51.1 vs. 51.6, p=0.26) than participants with a negative result (a higher score indicates better health). Furthermore, QOL scores were similar in positive FIT participants with either a negative or a positive colonoscopy. Positive FS participants tended to have worse QOL scores than negative participants, but these differences were not statistically significant. Conclusion: No significant differences existed in QOL scores between FS participants in this CRC screening program. Participants with a positive FIT had slightly worse QOL scores than participants with a negative screening test. However, these differences were small, and not clinically relevant. These findings may indicate that the burden of participating in CRC screening is limited. Conducting a prospective study to confirm these results is recommended. Scores of responders with a negative and a positive screening test
Background: While the use of anti-platelet agents such as low-dose aspirin (LDA) and clopidogrel in primary and secondary prophylaxis against cardiovascular and cerebrovascular diseases is increasing, LDA often causes not only gastric mucosal injury but also esophageal and small bowel mucosal injury, even at low doses and in enteric-coated form. However, clopidogrel generally carries a lower risk than LDA for inducing gastric mucosal injury. Given the uncertainty as to whether or not clopidogrel exacerbates LDA-induced gastric mucosal injury, we attempted to discern whether or not clopidogrel induced gastric mucosal injury and if PPI administration improved gastric mucosal injury inflicted by dual therapy with LDA + clopidogrel (Study 1). Further, we also examined whether or not extent of gastric mucosal injury by dual therapy depended on CYP2C19 genotype status (Study 2). Methods: In Study 1, ten subjects with different CYP2C19 genotypes received four randomized cross-over regimens (seven days each): LDA (100 mg; A), clopidogrel (75 mg; C), LDA and clopidogrel (AC), and LDA, clopidogrel, and rabeprazole (10 mg) (ACR). In Study 2, 30 subjects received the AC regimen for 7 days. On Days 3 and 7 of each regimen, gastroduodenoscopy was performed to assess extent of gastric mucosal injury based on the modified LANZA score (MLS), and an anti-platelet function test was conducted. We also determined the effects of the above drugs on 24-h intragastric pH values on Day 7. Results: Significant increases in extent of gastric mucosal injury on Day 3 and 7 were observed in not only regimens A (median MLS ranges: 1.7 [0-3.7] and 2.2 [0.0-5.0]) and AC (1.7 [04.0] and 2.5 [0.33-4.0]), but also regimen C (1.5 [0-3.0] and 0.33 [0.0-2.67]). However, the median MLS in regimen A was almost the same as that in regimen AC. Extent of gastric mucosal injury, 24-h intragastric pH, and anti-platelet effect differed by CYP2C19 genotype in the ACR regimen. Although the ACR regimen effectively inhibited gastric mucosal injury, the mean MLS in CYP2C19 rapid metabolizers was significantly higher than in intermediate or poor metabolizers (p = 0.028) due to insufficient acid inhibition (24-h pH p = 0.023). No effects on anti-platelet effect or intragastric pH could be attributed to interaction between rabeprazole and clopidogrel. Conclusions: The extent of gastric mucosal injury caused by clopidogrel was similar to that caused by LDA, particularly in the early phase of administration. However, clopidogrel did not exacerbate LDA-induced gastric mucosal injury, regardless of CYP2C19 genotype. Although rabeprazole effectively prevented both LDA- and clopidogrel-induced gastric mucosal injury without attenuating clopidogrel's anti-platelet function, its prophylactic effect on this gastric mucosal injury varied by CYP2C19 genotype.
S-735
AGA Abstracts