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Topical metronidazole for the treatment of pouchitis
COLON AND RECTUM 333
t335
A PATIENT SATISFACTION STUDY OF CT COLOGRAPHY (VIRTUAL COLONOSCOPY) AND COLONOSCOPY. J. R. Hecht, S.C. Chen, D.S.K. Lu, I.M. Gralnek. Depts. of Medicine and Radiology, UCLA School of Medicine, Los Angeles, CA 90095
OPEN-ACCESS FLEXIBLE SIGMOIDOSCOPY (OAFS): EVALUATION OF PATIENT COMPLIANCE AND APPROPRIATENESS OF REFERRAL. SJ Heller, S Syngal, J Wolf, PA Banks, DR Lichtenstein, RCK Weng, M Orifice, SA Cialfi, DL Curr-Locke, J Van Dam. Brigham and Women's Hospital, Harvard Medical School, Boston, MA. BACKGROUND: Open-aoceas flexible sigmoidoscopy has been instituted with the aim of improving efficiency aad eost-effcetiveness in colorectal cancer screening. Barriers to the success of OAFS include poor patient compliance and inappropriate referrals. AIM: To determine the incidence of patient compliance and appropriate referral in an OAFS program. MI~THOI)S: In the OAFS program at Brigham and Women's, mferrin~ physicians were given the option of directly scheduling their patients for flexible sigmoidoscopy, for enlorcetal cancer screening, or for the evaluntien of signs or symptoms. The OAFS program was evaluated prospectively. Patients completed questionnaires prior to sigmoidnsenpy that elicited the indication for the procedure, the presence of signs or symptoms related to the lower GI tract, and whether the physician believed a prior visit in the GI clinic would have been belpful. RESULTS: Of 732 flexible sigmoidoscopies scheduled between 9/19/95 and 11/5/96, 501 patients underwent their scheduled procedures (compliance rate 68%). The study group comprised 360 patients who underwent OAFS (F=237, 66%; M=123; 34%) (age range = 23-86 yrs) with completed questionnaires. The most common indications for referral were screenin~ for coloreetal cancer (65%) and rectal bleeding (23%). Significant pathology was as follows: carcinoma 1 (0.3%), adenoma 32 (9%), and colitis 4 (1%). The single cancer was detected at a curable stage (Dd~'s-Kirklin A) in a patientr with rectal bleeding. The incidence of adenoma was 9% in patients undergoing OAFS for enlorcetal cancer screening, and 10% in patients undergoing OAFS for rectal bleeding (p=NS). In 25 (7%) of 364 patients referred (4 patient cancellations), either the procedure was cancelled, the referral deemed inappropriate, or the gastroenterologist believed a prior clinic visit would have been helpful. No complications were reported. CONCLUSIONS:OAFS is an acceptable tool in the evaluation of patients for colorcctal cancer screening or uncomplicated lower GI complaints. 2) The high rate of poor patient compliance (32%) limits the efficiency of OAFS. 3) Inappropriate referral is a relatively minor barrier to the efficiency of OAFS. Education of patients and referring physicians, either by brochure or videotape, may be helpfol in improving the efficiency of OAFS.
B a c k g r o u n d Colorectal cancer is the second most common cause of cancer death in the United States. Unlike most other cancers, it is amenable to screening. Unfortunately, most Americans do not follow screening guidelines due to the perceived discomfort and embarrassment of current screening methods such as fecal occult blood testing and flexible sigmoidoscopy. Furthermore, these methods are neither sensitive nor specific for cancer or adenomas. Therefore, we established a pilot protocol to compare patient acceptance of a new technique of colonic imaging, CT colography (CTC), with colonoscopy. Methods Patients undergoing clinically indicated colonoscopies were recruited for the study. After bowel preparation, but before colonoscopy patients underwent CTC with air contrast using a GE helical scanner and thin sections. Image reconstruction was performed on graphics workstations with surface and volume rendering software. Before and after the procedures the patients filled out a questionnaire based on one previously used for acceptance of flexible sigmoidoscopy. (McCarthy & Moskowitz. J Gen Intern Med. 1993; 8:120-5.) R e s u l t s The first six patients showed a trend to anticipating more discomfort, pain, and anxiety with colonoscopy than with CTC. Post-procedure evaluation found neither procedure to be embarrassing and colonoscopy to be somewhat less uncomfortable, but slightly more painful than CTC. Most patients would have both procedures again if recommended. Pre Post Colon C I ~ Colon CTC Embarrassment 1.60 1.60 1.33 1.33 Discomfort 3.17 2.17 2.17 2.33 Pain 2.67 2.17 2.5 2.17 Anxiety 2.67 2.50 Range 1-4 with 4 being worst S u m m a r y If CTC is accurate and affordable, patient acceptance will be critical if it is to be an important method of colorectal screening. We report preliminary results of a patient satisfaction study of CTC in comparison to colonoscopy. More patients are needed to establish a preference and are being accrued.
+334
336
LONG-TERM ANALYSIS OF LASER THERAPY FOR COLONIC SESSILE ADENOMAS NOT AMENABLE TO POLYPECTOMY. S.K__ Heier. S. Pathapati, L.M. Heier, K. Hni. Dept of Med, NY Med Coll. Valhalla. NY.
TOPICAL METRONIDAZOLE FOR THE TREATMENT OF POUCHITIS. ~ J. Klanzak, M. Koruda Department of Medicine and Department of Surgery, University of North Carolina Hospitals, Chapel Hill, North Carolina,
Endoscopic Nd:YAG laser therapy (ELT) was evaluated as an alternative to surgical resection for colonic sessile adenomas (SA) not amenable to polypectomy (PP). We correlated success, time to obliteration and complications after ELT with location, size and histology of SA. METHODS: Patients with SA not amenable to PP, and refusing or not candidates for surgery, were treated with ELT in conjunction withpartial PP when possible. Therapy was repeated until r~epithelialization and negative biopsies. Frequently, ELT was delivered to residual nodularity which subsequently proved biopsy negative, perhaps reducing recurrence. Patients underwent surveillance with random biopsies at progressive intervals, until standard surveillance was instituted. RESULTS_: Of 68 consecutive patients age 70.8 + 1 1 . 6 (42-94), prior therapy included PP, injection assisted PP, surgery, transanal fulguration, and non-laser thermal ablation. Difficulties precluding PP included size, carpeting, accessibility behind folds and flexures, and multiple recurrences despite other therapies. Many SA (67%) were above the rectosigmoid junction, with 43% at or above the hepatic flexure. In 5 patients with terminal illnesses, palliative therapy was delivered for obstruction. Five patients underwent surgery, 1 after partial PP revealed invasive cancer, 1 by patient option and 3 when other intra-abdominal surge.r'/was indicated. In a 94 yo non-operative candidate, metastatic disease was discovered during partial PP/ELT. In 51 patients, successful ablation required 2.5 (1-11) therapies over 46.1 (1-202) days. Diameter of these SA was 4.1 (1-10) cm, with 66% above the rectosigmoid, and superficial cancer in 16. Size (greater or less than 5 era), but not location or histology, correlated with time to successful obliteration (74 vs. 39 days, P=0.019). There were no recurrences over a mean of 1751 days (Kaplan-Meier analysis; range 56-3364). One patient developed a probable metachronons lesion in the region of prior rectal therapy 6.8 yr later (negative visualization at 5.7 yr). ELT eratheated one large cecal SA extending into the ileum. Therapy is ongoing in two patients and was ongoing in two patients who died of other disease. Complications included bleeding requiring transfusion in 3 patients, 1 non-obstructing cecal stricture and 1 urinary retention. There was no mortality. CONCLUSIONS: In patients with SA not amenable to PP, ELT has a high success rate irrespective of size, location and presence of superficial carcinoma. Large SA over 5 cm may require more time for obliteration. Success of ELT wasprobably aided by adjunctive snare PP, and recurrence may have been reducedby ELT to nodularity which subsequently proved biopsy negative. SA treated by ELT may contain unsuspected mvasive carcinoma (1 in our series), warranting continued tissue sampling during therapy. Complications are few, and ELT is safe irrespective of age and coexistent illness. Long follow-up confirms a low recurrence rate. These data favor offering ELT as an alternative to surgery.
Introduction: Total abdominal colectomy with ileal pouch anal ~ ( I P A A ) is the most common surgical therapy for the treatment of medically refractory ulcerative colitis. Inflammation of the ileal pouch or pouchitis occurs in 15 - 30% of patients. Oral metronldazole is often the first drug used for treatment of pouchifis but may be poorly tolerated due to GI symptoms. TO evaluate the efficacy and tolerance of topical metrouldazole , Curatek Pharmaceuticals) in the treatment of pouchifis associated with IPAA for ulcerative colitis. Patients and Methods: A total of 8 treatments in 6 patients were completed. The symptoms patients presented with included an increase in baseline stool frequency, bleeding, decreased stool consistency and occasional systemic symptoms of fatigue and fever. Endoscopic evaluation of the pouch demonstrated ulceration, friability and edema. Patients were excluded if inflammatory changes extended above the pouch. 4 out of 6 patients treated had known past intolerance to oral metronidazole. In 50% this represented the first episode of pouchitis. Patients were treated with 1 applicator (37.5 mg metronidazole) bid to qid for 14 - 21 days. At the end of treatment symptoms were assessed. In 3 patients follow-up endoscopic examination of the pouch was performed. Results: All patients had return of their stool frequency to their baseline post operative stool frequency and resolution of bleeding. One of six patients developed GI intolerance similar to that with oral metronldazole. Another patient experienced mild rectal trauma with the applicator used to insert the gel into the pouch. The patients who were re-endoscopod had marked improvement of the pouch mucosa. Conclusions: In an open label study, low dose (75 - 150 rag/day) topical ~ e appears to be well tolerated and effective in the treatment of pouchitis associated with an ileal pouch anal anastomosis in the treatment of refractory ulcerative colitis. This drug is commercially available with applicator as a vaginal preparation (Metrogel, Curatek Pharmaceuticals) that is easily adapted for use through the rectum. Issues to be examined are duration of therapy, total daily dose of topical metronidazole and formulation issues. We have an ongoing controlled trial of oral vs. topical metrouldazole to more systematically and rigorously examine the side effect profile and the efficacy of therapy. (J. Klenzak supported by the Crohn's and Colitis Foundation)
AB108
GASTROINTESTINAL ENDOSCOPY
VOLUME 45, NO. 4, 1997
t335
A PATIENT SATISFACTION STUDY OF CT COLOGRAPHY (VIRTUAL COLONOSCOPY) AND COLONOSCOPY. J. R. Hecht, S.C. Chen, D.S.K. Lu, I.M. Gralnek. Depts. of Medicine and Radiology, UCLA School of Medicine, Los Angeles, CA 90095
OPEN-ACCESS FLEXIBLE SIGMOIDOSCOPY (OAFS): EVALUATION OF PATIENT COMPLIANCE AND APPROPRIATENESS OF REFERRAL. SJ Heller, S Syngal, J Wolf, PA Banks, DR Lichtenstein, RCK Weng, M Orifice, SA Cialfi, DL Curr-Locke, J Van Dam. Brigham and Women's Hospital, Harvard Medical School, Boston, MA. BACKGROUND: Open-aoceas flexible sigmoidoscopy has been instituted with the aim of improving efficiency aad eost-effcetiveness in colorectal cancer screening. Barriers to the success of OAFS include poor patient compliance and inappropriate referrals. AIM: To determine the incidence of patient compliance and appropriate referral in an OAFS program. MI~THOI)S: In the OAFS program at Brigham and Women's, mferrin~ physicians were given the option of directly scheduling their patients for flexible sigmoidoscopy, for enlorcetal cancer screening, or for the evaluntien of signs or symptoms. The OAFS program was evaluated prospectively. Patients completed questionnaires prior to sigmoidnsenpy that elicited the indication for the procedure, the presence of signs or symptoms related to the lower GI tract, and whether the physician believed a prior visit in the GI clinic would have been belpful. RESULTS: Of 732 flexible sigmoidoscopies scheduled between 9/19/95 and 11/5/96, 501 patients underwent their scheduled procedures (compliance rate 68%). The study group comprised 360 patients who underwent OAFS (F=237, 66%; M=123; 34%) (age range = 23-86 yrs) with completed questionnaires. The most common indications for referral were screenin~ for coloreetal cancer (65%) and rectal bleeding (23%). Significant pathology was as follows: carcinoma 1 (0.3%), adenoma 32 (9%), and colitis 4 (1%). The single cancer was detected at a curable stage (Dd~'s-Kirklin A) in a patientr with rectal bleeding. The incidence of adenoma was 9% in patients undergoing OAFS for enlorcetal cancer screening, and 10% in patients undergoing OAFS for rectal bleeding (p=NS). In 25 (7%) of 364 patients referred (4 patient cancellations), either the procedure was cancelled, the referral deemed inappropriate, or the gastroenterologist believed a prior clinic visit would have been helpful. No complications were reported. CONCLUSIONS:OAFS is an acceptable tool in the evaluation of patients for colorcctal cancer screening or uncomplicated lower GI complaints. 2) The high rate of poor patient compliance (32%) limits the efficiency of OAFS. 3) Inappropriate referral is a relatively minor barrier to the efficiency of OAFS. Education of patients and referring physicians, either by brochure or videotape, may be helpfol in improving the efficiency of OAFS.
B a c k g r o u n d Colorectal cancer is the second most common cause of cancer death in the United States. Unlike most other cancers, it is amenable to screening. Unfortunately, most Americans do not follow screening guidelines due to the perceived discomfort and embarrassment of current screening methods such as fecal occult blood testing and flexible sigmoidoscopy. Furthermore, these methods are neither sensitive nor specific for cancer or adenomas. Therefore, we established a pilot protocol to compare patient acceptance of a new technique of colonic imaging, CT colography (CTC), with colonoscopy. Methods Patients undergoing clinically indicated colonoscopies were recruited for the study. After bowel preparation, but before colonoscopy patients underwent CTC with air contrast using a GE helical scanner and thin sections. Image reconstruction was performed on graphics workstations with surface and volume rendering software. Before and after the procedures the patients filled out a questionnaire based on one previously used for acceptance of flexible sigmoidoscopy. (McCarthy & Moskowitz. J Gen Intern Med. 1993; 8:120-5.) R e s u l t s The first six patients showed a trend to anticipating more discomfort, pain, and anxiety with colonoscopy than with CTC. Post-procedure evaluation found neither procedure to be embarrassing and colonoscopy to be somewhat less uncomfortable, but slightly more painful than CTC. Most patients would have both procedures again if recommended. Pre Post Colon C I ~ Colon CTC Embarrassment 1.60 1.60 1.33 1.33 Discomfort 3.17 2.17 2.17 2.33 Pain 2.67 2.17 2.5 2.17 Anxiety 2.67 2.50 Range 1-4 with 4 being worst S u m m a r y If CTC is accurate and affordable, patient acceptance will be critical if it is to be an important method of colorectal screening. We report preliminary results of a patient satisfaction study of CTC in comparison to colonoscopy. More patients are needed to establish a preference and are being accrued.
+334
336
LONG-TERM ANALYSIS OF LASER THERAPY FOR COLONIC SESSILE ADENOMAS NOT AMENABLE TO POLYPECTOMY. S.K__ Heier. S. Pathapati, L.M. Heier, K. Hni. Dept of Med, NY Med Coll. Valhalla. NY.
TOPICAL METRONIDAZOLE FOR THE TREATMENT OF POUCHITIS. ~ J. Klanzak, M. Koruda Department of Medicine and Department of Surgery, University of North Carolina Hospitals, Chapel Hill, North Carolina,
Endoscopic Nd:YAG laser therapy (ELT) was evaluated as an alternative to surgical resection for colonic sessile adenomas (SA) not amenable to polypectomy (PP). We correlated success, time to obliteration and complications after ELT with location, size and histology of SA. METHODS: Patients with SA not amenable to PP, and refusing or not candidates for surgery, were treated with ELT in conjunction withpartial PP when possible. Therapy was repeated until r~epithelialization and negative biopsies. Frequently, ELT was delivered to residual nodularity which subsequently proved biopsy negative, perhaps reducing recurrence. Patients underwent surveillance with random biopsies at progressive intervals, until standard surveillance was instituted. RESULTS_: Of 68 consecutive patients age 70.8 + 1 1 . 6 (42-94), prior therapy included PP, injection assisted PP, surgery, transanal fulguration, and non-laser thermal ablation. Difficulties precluding PP included size, carpeting, accessibility behind folds and flexures, and multiple recurrences despite other therapies. Many SA (67%) were above the rectosigmoid junction, with 43% at or above the hepatic flexure. In 5 patients with terminal illnesses, palliative therapy was delivered for obstruction. Five patients underwent surgery, 1 after partial PP revealed invasive cancer, 1 by patient option and 3 when other intra-abdominal surge.r'/was indicated. In a 94 yo non-operative candidate, metastatic disease was discovered during partial PP/ELT. In 51 patients, successful ablation required 2.5 (1-11) therapies over 46.1 (1-202) days. Diameter of these SA was 4.1 (1-10) cm, with 66% above the rectosigmoid, and superficial cancer in 16. Size (greater or less than 5 era), but not location or histology, correlated with time to successful obliteration (74 vs. 39 days, P=0.019). There were no recurrences over a mean of 1751 days (Kaplan-Meier analysis; range 56-3364). One patient developed a probable metachronons lesion in the region of prior rectal therapy 6.8 yr later (negative visualization at 5.7 yr). ELT eratheated one large cecal SA extending into the ileum. Therapy is ongoing in two patients and was ongoing in two patients who died of other disease. Complications included bleeding requiring transfusion in 3 patients, 1 non-obstructing cecal stricture and 1 urinary retention. There was no mortality. CONCLUSIONS: In patients with SA not amenable to PP, ELT has a high success rate irrespective of size, location and presence of superficial carcinoma. Large SA over 5 cm may require more time for obliteration. Success of ELT wasprobably aided by adjunctive snare PP, and recurrence may have been reducedby ELT to nodularity which subsequently proved biopsy negative. SA treated by ELT may contain unsuspected mvasive carcinoma (1 in our series), warranting continued tissue sampling during therapy. Complications are few, and ELT is safe irrespective of age and coexistent illness. Long follow-up confirms a low recurrence rate. These data favor offering ELT as an alternative to surgery.
Introduction: Total abdominal colectomy with ileal pouch anal ~ ( I P A A ) is the most common surgical therapy for the treatment of medically refractory ulcerative colitis. Inflammation of the ileal pouch or pouchitis occurs in 15 - 30% of patients. Oral metronldazole is often the first drug used for treatment of pouchifis but may be poorly tolerated due to GI symptoms. TO evaluate the efficacy and tolerance of topical metrouldazole , Curatek Pharmaceuticals) in the treatment of pouchifis associated with IPAA for ulcerative colitis. Patients and Methods: A total of 8 treatments in 6 patients were completed. The symptoms patients presented with included an increase in baseline stool frequency, bleeding, decreased stool consistency and occasional systemic symptoms of fatigue and fever. Endoscopic evaluation of the pouch demonstrated ulceration, friability and edema. Patients were excluded if inflammatory changes extended above the pouch. 4 out of 6 patients treated had known past intolerance to oral metronidazole. In 50% this represented the first episode of pouchitis. Patients were treated with 1 applicator (37.5 mg metronidazole) bid to qid for 14 - 21 days. At the end of treatment symptoms were assessed. In 3 patients follow-up endoscopic examination of the pouch was performed. Results: All patients had return of their stool frequency to their baseline post operative stool frequency and resolution of bleeding. One of six patients developed GI intolerance similar to that with oral metronldazole. Another patient experienced mild rectal trauma with the applicator used to insert the gel into the pouch. The patients who were re-endoscopod had marked improvement of the pouch mucosa. Conclusions: In an open label study, low dose (75 - 150 rag/day) topical ~ e appears to be well tolerated and effective in the treatment of pouchitis associated with an ileal pouch anal anastomosis in the treatment of refractory ulcerative colitis. This drug is commercially available with applicator as a vaginal preparation (Metrogel, Curatek Pharmaceuticals) that is easily adapted for use through the rectum. Issues to be examined are duration of therapy, total daily dose of topical metronidazole and formulation issues. We have an ongoing controlled trial of oral vs. topical metrouldazole to more systematically and rigorously examine the side effect profile and the efficacy of therapy. (J. Klenzak supported by the Crohn's and Colitis Foundation)
AB108
GASTROINTESTINAL ENDOSCOPY
VOLUME 45, NO. 4, 1997