Diagnosing Functional Disorders of the Lower Gastrointestinal Tract Clinically: Are We Moving Nearer...
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PU-sponge connected to a drain was placed in the cavity through the overtube by a pusher device. The PU-sponge was connected to a vacuum bottle (video). Sponges were replaced twice a week, until wound cavity was smaller than approximately 10 cm3. Results: The mean estimated volume of para-anastomotic wound cavity at the time of diagnosis was 310 cm 3 (SD: 220-410 cm3). The 5th postoperative day was the average time to diagnosis of anastomotic leakage. The mean time to cut initial wound cavity size to 50% was 21d and the mean time to completion of endoluminale vacuum therapy was 35d. Mean time to normalization of WBC was 6d and of C-reactive protein 16d. In 10 of 16 patients the diverting enterostomy was closed during the study period. Conclusion: The local drainage of the wound cavity is optimized resulting in effective local infection control. Furthermore, closure of the wound cavity by applying vacuum therapy is accelerated. Therefore, endoluminale vacuum therapy appears as an effective supplement in management of anastomotic complications of the lower intestinal tract. W1599 Sigmoideoscopy in Diagnosis of Gastrointestinal Graft Versus Host Disease in Patients After Allogeneic Bone Marrow Transplantation - Three Years Experiences Ales Novotny, Marketa Markova, Ludek Voska, Antonin Vitek, Milan Lukas Introduction: Graft versus host disease (GVHD) is serious complication in patients after allogeneic bone marrow transplantation (aBMT). Up to 40% of patients after aBMT developed significant GVHD but patients with and without GVHD can not be simply distinguished only by clinical symptoms because of common unspecific gastrointestinal symptoms - nausea, vomiting, diarhoea etc. Early recognitions is necessary for succesful specific therapy. Endoscopic examination with mucosal biopsy and subsequent histological examination is used as a standard evaluation of gastrointestinal GVHD. Aims & methods: We performed analysis of 48 patients after aBMT for acute (AML), chronic (CML) myeloid leukemia and myelodysplastic syndrom (MDS) with lower gastrointestinal complaints suspected from gastrointestinal GVHD. Patients underwent lower endoscopy examination and we compared endoscopic and histologic findings. Results: 48 patients (22 men, 26 women, mean age 39,8 years, range between 19-63) after aBMT for AML (16pts), CML(20) and MDS (12pts) underwent altogether 72 sigmoideoscopic examinations. The mean time from aBMT was 74 days (range between 43-301). The indication for sigmoideoscopy was common gastrointestinal symptoms - lower dyspeptic complaints, abdominal pain, (bloody) diarhoea etc. Biopsy samples were taken from rectal and sigmoid mucosa. Sigmoideoscopy was negative in 22 cases, in 34 cases we found mild mucosal changes (oedema, reduced vascular pattern, buckling of mucosa as ‘‘bark of tree’’) and in 16 cases we found erosion, haemorhagy and buckling of mucosa. Histology confirmation of GVHD in macroscopic normal findings was in 5 cases (23%), in mild endoscopic findings in 24 cases (70,5%) and in heavy macroscopic changes histology was pozitive in 14 cases (87,5%). Senzitivity of the all sigmoidoscopic macroscopical mucosal changes for GVHD diagnosis was 76%, specificity 77%, pozitive predictive value 88% and negative predictive value 59%. Only heavy macroscopic changes had more better results. Conclusion: Endoscopic findings are promising for diagnosis of gastrointestinal GVHD in a patients after aBMT. The more advanced macroscopical mucosal changes are observed, the higher is sensitivity, specificity and pozitive predictive value. But out of spite promising endoscopic results, histology evaluation remains gold standard for gastrointestinal GVHD diagnosis. W1600 Diagnosing Functional Disorders of the Lower Gastrointestinal Tract Clinically: Are We Moving Nearer Or Farther? Jijo V. Cherian, Arun Kumar Muthusamy, Jayanthi Venkatraman Introduction: In clinical practice, the diagnosis of functional bowel disorders and functional abdominal pain syndrome is predominantly one of exclusion. This study aimed at assessing the value of clinical symptoms, basicinvestigations and the utility of colonoscopy in differentiating organic disease from functional disorders of the lower gastrointestinal tract. Methods: Data was collected prospectively from consecutive patients with a lower gastrointestinal complaint requiringa colonoscopy for evaluation. The ability of the symptoms, clinical examination, abnormalities on basic laboratory parameters and colonoscopy to predict an underlying organic disease was assessed. Results: Eighty-three patients entered the study following the inclusion and exclusion criteria. 65.1% patients had afunctional disorder and 34.9% had an organic lower GI illness. No differences in the mean age or genderratio were noted between the two groups. The mean duration of symptoms in the functional group was significantly longer. The variables that showed statistical significance in differentiating an organic from a functional lower GI disease on multivariate analysis were passage of blood in stools (p Z 0.02), weight loss (p Z 0.01), abdominal tenderness (p Z 0.004), anemia (p Z 0.007), presence of mass abdomen (p Z 0.01) and abnormalities on colonoscopy (p Z 0.02). With the addition of colonoscopy to the diagnostic algorithm the sensitivity improved to 100% and specificity to 97%. Conclusion: Clinical diagnosis of functional bowel disorders have poor sensitivity and specificity, suggesting that it may be appropriate that the Rome criteria be expanded to include key alarm features, basic investigations and colonoscopy. Sensitivity, Specificity, PPV, NPV and efficacy at various stages of evaluation Vs final diagnosis Clinical Vs final diagnosis (stage I) Clinical D Investigations Vs final diagnosis (stage II) Clinical D investigations D colonoscopy Vs final diagnosis (stage III) STAGES Estimated value (%) 95% CI (%) Estimated value (%) 95% CI (%) Estimated value (%) 95% CI (%) Sensitivity 57 43-71 69 55-80 100 93-100 Specificity 83 64-94 62 42-79 97 82-100 PPV 86 71-95 77 63-88 98 90-100 NPV 51 36-66 51 34-68 100 87-100 Efficacy 66 55-76 66 55-76 99 93-100 Kappa Stats 0.35, p Z 0.001 Fair agreement 0.29, p Z 0.001 Fair agreement 0.97, p Z 0.001 Perfect agreement W1601 Comparison of the Efficacy, Tolerability and Safety of PEG Solution (FORTRANsÒ) with Simethicone Vs Conventional Method of Preparation Before Colonoscopy: A Multicentre Study Boris Poddubny, Sergey V. Kashin, Leonid Shubin, Vitaly Goncharov, Sergey Mazurov, Alexander Agamov Introduction: Diagnostic accuracy and therapeutic safety of colonoscopy depend on the quality of the colonic preparation. Polyethylene glycol solution (PEG) was demonstrated to be an effective method in bowel preparation before colonoscopy, but frequently residual foam may obscure small mucosal lesions. Conventional method (CM) of bowel preparation which consists of combination of dietary restrictions, oral cathartics (castor oil) and enemas has proven to be safe, cheap and therefore widely used in Eastern European countries, especially in cases of PEG intolerance. Aims & methods: The aim of this study was to compare the quality of bowel cleansing with PEG (FortransÒ) in combination with simethicone FS vs CM. 60 patients were enrolled in this study in both centres from November 2005 till June 2006. Every patient passed colonoscopy twice in a 2 month period. First assessment was performed after preparation with CM and second after FS. The primary endpoint of the study was the quality of colon cleansing as determined by video imaging. Secondary endpoints were the detection of small pathological lesions (adenomas) by using indigocarmine chromocolonoscopy, safety and patient acceptability of the procedure. Results: 120 colonoscopies were performed in 60 patients. The assessment of entire colonic mucosa and the quality of cleansing according to residual stool and fluid graded by 4-point scale were excellent and good in 47% and 88%, poor - in 48% and 12% in CM and FS groups respectively (the differences between two groups were assessed using Wilcoxon W-test, W-985,0, p ! 0,001). The mean cecal intubation time was 16,93 0,94 min after CM and 10,68 0,88 min after FS (p ! 0,001). The total duration for colonoscopy was 29,10 1,16 min in CM and 26,68 1,14 min (p Z 0,071) in FS groups. Residual foam was revealed in 27% and 10% of colons prepared with CM and FS respectively. Chromocolonoscopy was successfully performed in 45% patients prepared with CM and in 95% patients after preparation with FS. Number of detected adenomas was 1,04 (max 10) and 1,64 (max 14) in CM and FS groups respectively (t-test for dependent samples, t-4, 12, p ! 0,001). There were not any adverse events registered in both groups. Conclusion: Our study showed that FS is the safe and well tolerated method with high quality of bowel preparation. This method appears to have 51% higher diagnostic accuracy and 25,5% higher sensitivity in detection of adenomas compared to CM. FS could be recommended as a standard method for bowel preparation before colonoscopy. W1602 Pharmacokinetic Modelling of a Healthy Volunteer Study for the Assessments of the Ascorbic Acid Effects in PEGDE Containing Gut Cleansing Solutions Hans-Jurgen Gruss Introduction: The effectiveness of a colonoscopy depends on a good bowel preparation. Standard polyethylene glycol 3350 plus electrolytes (PEGþE) containing solutions require usually the intake of 4 litres. Recently, low volume PEG þ E solutions have been introduced. One of the 2 litres preparations contains in addition ascorbic acid to increase the osmotic effect and to improve the taste. A number of clinical studies have confirmed the efficacy and safety. The mode of action is not fully understood. Aims & methods: To understand the effects of ascorbic acid in a low-volume PEGþE bowel preparation (MoviPrep: PEG þ Asc) a healthy volunteer study was conducted. Consenting male subjects (n Z 24) were randomized to take either PEGþAsc in a single dose (SD) the evening or a split dose (SpD: 1 litre each) in the evening and the following morning. The primary endpoint was a pharmacokinetic analysis and mass balance calculation of ascorbic acid, PEG3350 and electrolytes during and after dosing compared to baseline values. Serial blood samples were measured during the baseline period and up to Abstracts AB324 GASTROINTESTINAL ENDOSCOPY Volume 67, No. 5 : 2008 www.giejournal.org
Transcript of Diagnosing Functional Disorders of the Lower Gastrointestinal Tract Clinically: Are We Moving Nearer...
Abstracts
PU-sponge connected to a drain was placed in the cavity through the overtube bya pusher device. The PU-sponge was connected to a vacuum bottle (video).Sponges were replaced twice a week, until wound cavity was smaller thanapproximately 10 cm3. Results: The mean estimated volume of para-anastomoticwound cavity at the time of diagnosis was 310 cm 3 (SD: 220-410 cm3). The 5thpostoperative day was the average time to diagnosis of anastomotic leakage. Themean time to cut initial wound cavity size to 50% was 21d and the mean time tocompletion of endoluminale vacuum therapy was 35d. Mean time to normalizationof WBC was 6d and of C-reactive protein 16d. In 10 of 16 patients the divertingenterostomy was closed during the study period. Conclusion: The local drainage ofthe wound cavity is optimized resulting in effective local infection control.Furthermore, closure of the wound cavity by applying vacuum therapy isaccelerated. Therefore, endoluminale vacuum therapy appears as an effectivesupplement in management of anastomotic complications of the lower intestinaltract.
W1599
Sigmoideoscopy in Diagnosis of Gastrointestinal Graft Versus
Host Disease in Patients After Allogeneic Bone Marrow
Transplantation - Three Years ExperiencesAles Novotny, Marketa Markova, Ludek Voska, Antonin Vitek,Milan LukasIntroduction: Graft versus host disease (GVHD) is serious complication in patientsafter allogeneic bone marrow transplantation (aBMT). Up to 40% of patients afteraBMT developed significant GVHD but patients with and without GVHD can not besimply distinguished only by clinical symptoms because of common unspecificgastrointestinal symptoms - nausea, vomiting, diarhoea etc. Early recognitions isnecessary for succesful specific therapy. Endoscopic examination with mucosalbiopsy and subsequent histological examination is used as a standard evaluation ofgastrointestinal GVHD. Aims & methods: We performed analysis of 48 patients afteraBMT for acute (AML), chronic (CML) myeloid leukemia and myelodysplasticsyndrom (MDS) with lower gastrointestinal complaints suspected fromgastrointestinal GVHD. Patients underwent lower endoscopy examination and wecompared endoscopic and histologic findings. Results: 48 patients (22 men, 26women, mean age 39,8 years, range between 19-63) after aBMT for AML (16pts),CML(20) and MDS (12pts) underwent altogether 72 sigmoideoscopic examinations.The mean time from aBMTwas 74 days (range between 43-301). The indication forsigmoideoscopy was common gastrointestinal symptoms - lower dyspepticcomplaints, abdominal pain, (bloody) diarhoea etc. Biopsy samples were takenfrom rectal and sigmoid mucosa. Sigmoideoscopy was negative in 22 cases, in 34cases we found mild mucosal changes (oedema, reduced vascular pattern, bucklingof mucosa as ‘‘bark of tree’’) and in 16 cases we found erosion, haemorhagy andbuckling of mucosa. Histology confirmation of GVHD in macroscopic normalfindings was in 5 cases (23%), in mild endoscopic findings in 24 cases (70,5%) andin heavy macroscopic changes histology was pozitive in 14 cases (87,5%). Senzitivityof the all sigmoidoscopic macroscopical mucosal changes for GVHD diagnosis was76%, specificity 77%, pozitive predictive value 88% and negative predictive value59%. Only heavy macroscopic changes had more better results. Conclusion:Endoscopic findings are promising for diagnosis of gastrointestinal GVHD ina patients after aBMT. The more advanced macroscopical mucosal changes areobserved, the higher is sensitivity, specificity and pozitive predictive value. But outof spite promising endoscopic results, histology evaluation remains gold standardfor gastrointestinal GVHD diagnosis.
W1600
Diagnosing Functional Disorders of the Lower Gastrointestinal
Tract Clinically: Are We Moving Nearer Or Farther?Jijo V. Cherian, Arun Kumar Muthusamy, Jayanthi VenkatramanIntroduction: In clinical practice, the diagnosis of functional bowel disorders andfunctional abdominal pain syndrome is predominantly one of exclusion. This studyaimed at assessing the value of clinical symptoms, basicinvestigations and the utilityof colonoscopy in differentiating organic disease from functional disorders of thelower gastrointestinal tract. Methods: Data was collected prospectively fromconsecutive patients with a lower gastrointestinal complaint requiringacolonoscopy for evaluation. The ability of the symptoms, clinical examination,abnormalities on basic laboratory parameters and colonoscopy to predict anunderlying organic disease was assessed. Results: Eighty-three patients entered thestudy following the inclusion and exclusion criteria. 65.1% patients had afunctionaldisorder and 34.9% had an organic lower GI illness. No differences in the mean ageor genderratio were noted between the two groups. The mean duration ofsymptoms in the functional group was significantly longer. The variables thatshowed statistical significance in differentiating an organic from a functional lowerGI disease on multivariate analysis were passage of blood in stools (p Z 0.02),weight loss (p Z 0.01), abdominal tenderness (p Z 0.004), anemia (p Z 0.007),presence of mass abdomen (p Z 0.01) and abnormalities on colonoscopy (p Z0.02). With the addition of colonoscopy to the diagnostic algorithm the sensitivityimproved to 100% and specificity to 97%. Conclusion: Clinical diagnosis offunctional bowel disorders have poor sensitivity and specificity, suggesting that it
AB324 GASTROINTESTINAL ENDOSCOPY Volume 67, No. 5 : 2008
may be appropriate that the Rome criteria be expanded to include key alarmfeatures, basic investigations and colonoscopy.
Sensitivity, Specificity, PPV, NPV and efficacy at various stages of evaluationVs final diagnosis
Clinical Vs finalClinical D Investigations
Vs final diagnosisClinical D investigations D
colonoscopy Vs final
diagnosis (stage I) (stage II) diagnosis (stage III)STAGES
Estimatedvalue (%)95%CI (%)
Estimatedvalue (%)
95%CI (%)
Estimatedvalue (%)
www.gie
95%CI (%)
Sensitivity
57 43-71 69 55-80 100 93-100 Specificity 83 64-94 62 42-79 97 82-100 PPV 86 71-95 77 63-88 98 90-100 NPV 51 36-66 51 34-68 100 87-100 Efficacy 66 55-76 66 55-76 99 93-100 KappaStats0.35,p Z 0.001
Fairagreement
0.29,p Z 0.001
Fairagreement
0.97,p Z 0.001
Perfectagreement
W1601
Comparison of the Efficacy, Tolerability and Safety of PEG
Solution (FORTRANs�) with Simethicone Vs Conventional
Method of Preparation Before Colonoscopy: A Multicentre StudyBoris Poddubny, Sergey V. Kashin, Leonid Shubin, Vitaly Goncharov,Sergey Mazurov, Alexander AgamovIntroduction: Diagnostic accuracy and therapeutic safety of colonoscopy dependon the quality of the colonic preparation. Polyethylene glycol solution (PEG) wasdemonstrated to be an effective method in bowel preparation before colonoscopy,but frequently residual foam may obscure small mucosal lesions. Conventionalmethod (CM) of bowel preparation which consists of combination of dietaryrestrictions, oral cathartics (castor oil) and enemas has proven to be safe, cheapand therefore widely used in Eastern European countries, especially in cases of PEGintolerance. Aims & methods: The aim of this study was to compare the quality ofbowel cleansing with PEG (Fortrans�) in combination with simethicone FS vs CM.60 patients were enrolled in this study in both centres from November 2005 tillJune 2006. Every patient passed colonoscopy twice in a 2 month period. Firstassessment was performed after preparation with CM and second after FS. Theprimary endpoint of the study was the quality of colon cleansing as determined byvideo imaging. Secondary endpoints were the detection of small pathologicallesions (adenomas) by using indigocarmine chromocolonoscopy, safety and patientacceptability of the procedure. Results: 120 colonoscopies were performed in 60patients. The assessment of entire colonic mucosa and the quality of cleansingaccording to residual stool and fluid graded by 4-point scale were excellent andgood in 47% and 88%, poor - in 48% and 12% in CM and FS groups respectively (thedifferences between two groups were assessed using Wilcoxon W-test, W-985,0, p !0,001). The mean cecal intubation time was 16,93 � 0,94 min after CM and 10,68 �0,88 min after FS (p ! 0,001). The total duration for colonoscopy was 29,10 � 1,16min in CM and 26,68 � 1,14 min (p Z 0,071) in FS groups. Residual foam wasrevealed in 27% and 10% of colons prepared with CM and FS respectively.Chromocolonoscopy was successfully performed in 45% patients prepared with CMand in 95% patients after preparation with FS. Number of detected adenomas was1,04 (max 10) and 1,64 (max 14) in CM and FS groups respectively (t-test fordependent samples, t-4, 12, p ! 0,001). There were not any adverse eventsregistered in both groups. Conclusion: Our study showed that FS is the safe andwell tolerated method with high quality of bowel preparation. This method appearsto have 51% higher diagnostic accuracy and 25,5% higher sensitivity in detection ofadenomas compared to CM. FS could be recommended as a standard method forbowel preparation before colonoscopy.
W1602
Pharmacokinetic Modelling of a Healthy Volunteer Study for the
Assessments of the Ascorbic Acid Effects in PEGDE Containing
Gut Cleansing SolutionsHans-Jurgen GrussIntroduction: The effectiveness of a colonoscopy depends on a good bowelpreparation. Standard polyethylene glycol 3350 plus electrolytes (PEGþE)containing solutions require usually the intake of 4 litres. Recently, low volumePEG þ E solutions have been introduced. One of the 2 litres preparations containsin addition ascorbic acid to increase the osmotic effect and to improve the taste. Anumber of clinical studies have confirmed the efficacy and safety. The mode ofaction is not fully understood. Aims & methods: To understand the effects ofascorbic acid in a low-volume PEGþE bowel preparation (MoviPrep: PEG þ Asc)a healthy volunteer study was conducted. Consenting male subjects (n Z 24) wererandomized to take either PEGþAsc in a single dose (SD) the evening or a splitdose (SpD: 1 litre each) in the evening and the following morning. The primaryendpoint was a pharmacokinetic analysis and mass balance calculation of ascorbicacid, PEG3350 and electrolytes during and after dosing compared to baselinevalues. Serial blood samples were measured during the baseline period and up to
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