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Endoscopy in the pregnant patient with inflammatory bowel disease.

Although little data exist directly evaluating the utility and safety of endoscopy in the pregnant woman with IBD, it appears to be well tolerated by both mother and fetus, and provides useful clinical information. When performed to evaluate gastrointestinal bleeding, EGD has a high diagnostic yield, while EGD for nausea and vomiting is less informative. In the patient without IBD presenting with hematochezia, unexplained diarrhea, severe abdominal pain, or severe rectal pain, careful sigmoidoscopic examination is indicated, often leading to a diagnosis of new-onset or unsuspected IBD. Likewise, the pregnant IBD patient with worsening symptoms, despite appropriate medical therapy, may also benefit from sigmoidoscopy. Colonoscopy is less often indicated, but can be safely performed in the carefully selected pregnant patient. In all cases obstetrical consultation should be obtained prior to endoscopy, and the risks and benefits of endoscopy to both mother and child should be considered. Close attention should be paid to appropriate drug selection for conscious sedation, and sedation should be administered to provide patient comfort, while avoiding oversedation. Extrapolating from data obtained during endoscopic examination of the pregnant non-IBD patient, fetal monitoring is generally not indicated, although it should be considered for the high-risk or late third-trimester patient. Following these principles assures that endoscopy can be safely performed in the pregnant IBD patient with the best possible outcome for both mother and baby.

Procedural Sedation↗

Incidence and clinical presentation of bowel ischaemia after aortoiliac surgery--2930 operations from a population-based registry in Sweden.

OBJECTIVES: To study the incidence and clinical presentation of intestinal ischaemia after aortoiliac/femoral surgery, and to validate a vascular registry concerning a serious complication. DESIGN AND SETTING: In the Swedish Vascular Registry (SWEDVASC) the outcome and complications of all vascular procedures are registered prospectively. MATERIALS AND METHODS: All 2930 patients operated in 1987-93 were analysed for notified complications. A 5% random sample of all patients and a 20% random sample of fatal cases were analysed for un-notified complications. Of 415 requested patient records 413 were analysed. RESULTS: The estimated incidence of bowel ischaemia was 2.8%. Among patients operated on for a ruptured aneurysm in shock it was 7.3%. Of the 63 patients with intestinal ischaemia only 15 presented with early passage of bloody stools. In 60 patients (95%) the lesion affected the left colon within the reach of a sigmoidoscope. Bowel ischemia was unnotified only in fatal cases, the estimated un-notified complication rate was 0.7%. CONCLUSIONS: The incidence in this study on unselected patients did not differ from previous reports from specialised centres. Diagnosis is difficult and justifies a high index of suspicion and early use of sigmoidoscopy. The validity of the SWEDVASC registry was confirmed by a high report-rate for this complication.

Aged↗

A randomized trial of nicotine enemas for active ulcerative colitis.

BACKGROUND & AIMS: Ulcerative colitis (UC) is largely a disease of nonsmokers in which transdermal nicotine improves the symptoms but often causes adverse events (AEs). Nicotine enemas cause fewer AEs and were used as supplemental treatment for active UC. METHODS: We treated 104 patients with active UC with either 6-mg nicotine enemas or placebo enemas for 6 weeks in a randomized double-blind study. Patients continued their oral therapy, if any, for UC: 68 patients were taking mesalamine, 15 patients were taking prednisolone, and 12 patients were taking thiopurines during the study. Clinical, sigmoidoscopic, and histologic assessments were made at baseline and at the end of the study and symptoms were recorded daily on a diary card. The primary end point was induction of clinical remission and clinical improvement also was measured by the UC disease activity index. After the study, patients then used nicotine enemas daily for 4 weeks and sigmoidoscopy with a biopsy examination was repeated. AEs and salivary cotinine levels were monitored throughout the study. RESULTS: Clinical remission was achieved in 14 of 52 (27%) patients on active treatment and 14 of 43 (33%) patients on placebo (P = .55). The UC disease activity index improved by 1.45 points in the active group and by 1.65 points for those on placebo (P = .88). Only 1 patient discontinued treatment because of an AE (abdominal pain). In the 47 patients taking mesalamine only, active treatment conferred benefit that was not statistically significant; disease remission occurred in 9 of 25 patients on active therapy and 4 of 21 patients on placebo (P = .20). CONCLUSIONS: Six-milligram nicotine enemas were well tolerated but were not found to be efficacious for active UC.

Adult↗

Distal proctocolitis and n-3 polyunsaturated fatty acids (n-3 PUFAs): the mucosal effect in situ.

It has been postulated that patients with ulcerative colitis (UC) have altered reactivity of gut-associated lymphoid tissue. In such cases there is intense infiltration of the mucosa with immune competent cells and associated tissue damage. We have shown previously that the dietary supplementation with the n-3 polyunsaturated fatty acids (n-3 PUFAs), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) results in significant systemic immune suppression. The aim of this study, therefore, was to evaluate the in situ effect of n-3 PUFAs on distal proctocolitis. Each patient received either fish oil extract (EPA 3.2 g, DHA 2.4 g) (n = 9) or sunflower oil (n = 9) daily in a double blind manner for six months. Monthly assessment included: (1) disease activity using clinical, sigmoidoscopic, and histological scores and (2) immunohistochemical analysis (immunoglobulins, CD profiles) of rectal biopsy specimens (before and after six months supplementation) using monoclonal antibodies and quantitative computer-assisted video image analysis. Prior to receiving supplementation, patients with proctocolitis (n = 18) showed significantly higher numbers of cells expressing CD3 (pan T cells) and HLA-DR and IgM containing cells compared with non-colitic controls (n = 8). Six months supplementation with n-3 PUFAs resulted in significant reduction in the number of cells expressing CD3 and HLA and the percentage of cells containing IgM. There was no significant change in the CD20 nor the percentage of IgG or IgA containing cells in either group of patients with procto-colitis. In patients receiving n-3 PUFA supplementation, there was improvement in the disease activity and histological scores, compared with pretreatment evaluation. This study has demonstrated both evidence of suppression of in situ immune reactivity and concurrent reduction in disease activity in patients with proctocolitis receiving n-3 PUFA supplementation. This may have important implication for therapy in patients with ulcerative colitis.

Animals↗

Sucralfate and methylprednisolone enemas in active ulcerative colitis: a prospective, single-blind study.

In order to investigate the role of sucralfate in active ulcerative colitis, 60 patients were randomized to receive either sucralfate enemas (20 g/100 ml) or methylprednisolone enemas (20 mg/100 ml). The enemas were administered twice daily for one week, and then once daily for three weeks. Clinical evaluation was documented at entry and at two weeks and four weeks. The sigmoidoscopic appearance of the rectal mucosa was scored, and rectal biopsies taken at entry and at four weeks. Results indicated similar reduction in diarrhea and rectal bleeding at two weeks and at four weeks. Sigmoidoscopy demonstrated similar significant improvement in the macroscopic appearance of the rectal mucosa in both groups (8.28 to 6.20 in sucralfate group, P < 0.02; and 8.72 to 6.36 in the methylprednisolone treated group, P < 0.04). Histologic assessment, likewise, showed similar improvements in the two groups. This study indicates that sucralfate enemas may be useful in the treatment of ulcerative proctosigmoiditis.

Administration, Topical↗

Controlled trial of 4-ASA in ulcerative colitis.

A six-week placebo-controlled trial of the efficacy and safety of 6 g per day of 4-aminosalicylic acid (4-ASA) was conducted in 30 subjects with mild to moderately severe ulcerative colitis. Subjects were stratified into groups having distal (< 60 cm) or more extensive (> 60 cm) disease. Diarrhea, bleeding, sigmoidoscopic and biopsy appearance, and physician global assessment were scored to judge efficacy. Safety was evaluated by monitoring untoward symptoms and laboratory values. Median percent improvement was significantly greater (P < 0.05) in the 4-ASA > 60-cm group (42.7%) than in the placebo > 60-cm group (21.2%), but 4-ASA was not better than placebo for the < 60-cm group or the total study group. Severe dyspepsia (one subject), abnormal AST (transient in five, persistent in one) and elevated lipase without pancreatitis (six subjects) were noted. Thus 6 g 4-ASA for six weeks was more effective than placebo in mild to moderate ulcerative colitis extending more than 60 cm above the anus, but not in distal disease, and the drug was generally well tolerated.

Aminosalicylic Acid↗

Natural history of late radiation proctosigmoiditis treated with topical sucralfate suspension.

Rectal bleeding due to radiation proctosigmoiditis is often difficult to manage. We had earlier shown the efficacy of short-term therapy with topical sucralfate in controlling bleeding in the radiation proctosigmoiditis. We now report our long-term results with this form of therapy. The study comprised 26 patients with radiation proctosigmoiditis. Sigmoidoscopically, 9 (34.6%) patients had severe changes, 15 (57.69%) had moderate, and 2 (7.69%) had mild changes. Severity of bleeding was graded as severe (> 15 episodes per week), moderate (8-14 episodes per week), mild (2-7 episodes per week), negligible (< or = 1 episode per week), or nil (no bleeding). Ten patients had moderate rectal bleeding, while 16 had severe bleeding. All patients were treated with 20 ml of 10% rectal sucralfate suspension enemas twice a day until bleeding per rectum ceased or failure of therapy was acknowledged. Response to therapy was considered good whenever the severity of bleeding showed improvement by a change of two grades. Rectally administered sucralfate achieved good response in 20 (76.9%) patients at 4 weeks, 22 (84.6%) patients at 8 weeks, and 24 (92.3%) patients at 16 weeks. This change was significant by Wilcoxon matched-pairs signed-ranks test. Two patients required surgery due to poor response. Over a median follow-up of 45.5 months (range 5-73 months) after cessation of bleeding, 17 (70.8%) patients had no further bleeding while 7 (22.2%) had recurrence of bleeding. All recurrences responded to short-term reinstitution of therapy. No treatment-related complications were observed. Ten patients had other associated late toxicity due to pelvic irradiation in the form of asymptomatic rectal stricture (N = 3), rectovaginal fistula (N = 1), intestinal stricture (N = 1), vaginal stenosis (N = 1), and hematuria (N = 6). Three patients had progression of the primary disease in the form of pelvic recurrence (N = 2) and hepatic metastases (N = 1). We conclude that topical sucralfate induces a lasting remission in a majority of patients with moderate to severe rectal bleeding due to radiation proctosigmoiditis.

Administration, Topical↗

Sucralfate and hydrocortisone enemas in the treatment of active ulcerative proctitis--a randomized single-blind comparative study.

BACKGROUND: Sucralfate is a non-absorbable aluminium salt of sucrose octasulphate which in recent studies has proved to be of possible use in the treatment of active distal ulcerative colitis. AIM: The aim of this randomized, single-blind, study was to compare 10 g sucralfate with 100 mg hydrocortisone enemas in the treatment of 40 patients (26 male and 14 female; mean age 36.5 years, range 18-65 years) with active ulcerative proctitis, twice daily for 4 weeks. METHODS: A clinical, sigmoidoscopic and histological assessment was performed before and 4 weeks after the start of the therapy. RESULTS: Both treatments showed significant within-treatment improvement in clinical, endoscopic and histological grades (Wilcoxon's matched pair test, P < 0.05). Between-treatment comparisons, using the Mann-Whitney test, showed that hydrocortisone is more effective than sucralfate in improving the clinical score (P < 0.05). CONCLUSIONS: Sucralfate enema treatment, which was significantly less effective than hydrocortisone enemas in this study, has very limited use in the treatment of active ulcerative proctitis.

Administration, Topical↗

Nicotine tartrate liquid enemas for mildly to moderately active left-sided ulcerative colitis unresponsive to first-line therapy: a pilot study.

BACKGROUND: Ulcerative colitis is predominantly a disease of non-smokers, and transdermal nicotine is therapeutic but often results in side-effects. Administration of nicotine as a liquid rectal enema results in less systemic nicotine absorption. AIM: To determine the safety and clinical response of nicotine tartrate liquid enemas for active left-side ulcerative colitis in a pilot study. METHODS: Ten non-smoking patients with mildly to moderately active left-sided ulcerative colitis unresponsive to first-line therapy were treated in an open protocol with nightly nicotine tartrate liquid enemas at a dose of 3 mg nicotine base for 1 week then 6 mg for 3 weeks. Clinical assessments were determined at baseline and 4 weeks by endoscopy, physician assessment and a patient diary of daily symptoms. Peak and trough serum nicotine and trough plasma cotinine were determined by gas chromatography/mass spectrometry and high performance liquid chromatography, respectively. RESULTS: After 4 weeks of treatment, 5/7 patients (71%) showed clinical and sigmoidoscopic improvement (per protocol analysis). The other three patients discontinued therapy within 7 days because of inability to retain the liquid enemas. No patients showed histologic improvement. Six of the patients who completed the 4-week study had peak and trough serum nicotine concentration determined, only 1 of 6 patients had a detectable peak nicotine concentration (value 2.3 ng/mL), and all six patients had undetectable trough nicotine concentrations. The mean trough plasma cotinine concentration was 13 +/- 10 ng/mL. Transient and mild adverse events occurred in 4/10 patients (nausea, lightheadedness, tremor, sleep disturbance). Given the low or undetectable serum nicotine concentrations, these adverse events are not likely to be related to the nicotine enemas. CONCLUSIONS: Nicotine tartrate liquid enemas administrated at a dose of 3 mg nicotine base/day for 1 week and then 6 mg/day for 3 weeks are safe and appear to result in clinical improvement in some patients with mildly to moderately active, left-sided ulcerative colitis unresponsive to first-line therapy. Placebo-controlled trials are warranted to confirm these preliminary findings.

Adult↗

Nicotine enemas for active ulcerative colitis--a pilot study.

BACKGROUND: Since transdermal nicotine is of value in the treatment of active ulcerative colitis but is often associated with side-effects, an alternative in the form of topical therapy with nicotine enemas has been developed. METHODS: In an open study, 22 patients with active colitis, all non-smokers, were asked to take a 100 mL enema containing 6 mg of nicotine every night for 4 weeks. Pre-trial treatment using mesalazine (n = 16), oral prednisolone (8), cyclosporin (1) and azathioprine (1) was kept constant for the month prior to assessment and during the study period. Symptoms, with stool frequency, were recorded on a diary card and an endoscopy was performed with rectal biopsy at the beginning of the study and after 4 weeks. RESULTS: Seventeen of the 22 patients completed 1 month of treatment. Mean duration of relapse was 29 weeks, range 3-94. Sixteen of 17 improved their St Mark's score. Urgency and stool frequency improved in 12 patients, sigmoidoscopic and histological scores in 10. Three patients had a full remission of symptoms with normal sigmoidoscopy. Six of 10 with a partial response continued with the enemas for a second month and five showed further improvement with full remission in two. The enema appeared effective when added to conventional treatment and produced few side-effects. CONCLUSION: Topical nicotine therapy for ulcerative colitis may have a place in future management, but controlled studies are needed.

Adult↗

Treatment of ulcerative colitis with an engineered human anti-TNFalpha antibody CDP571.

BACKGROUND: Tumour Necrosis Factor-alpha (TNFalpha) is a pro-inflammatory cytokine whose expression is increased in the colonic mucosa of patients with active ulcerative colitis. TNFalpha antibodies have been shown to be beneficial in animal models of bowel inflammation and in Crohn's disease but have not previously been studied in ulcerative colitis. METHODS: Patients with mild/moderate ulcerative colitis were treated openly with a single intravenous infusion of 5 mg/kg of an engineered human IgGgamma4 antibody CDP571 and monitored for 8 weeks. RESULTS: Fifteen patients entered the study, eight males and seven females, with a mean age of 44 years. Eleven had left-sided disease, four extensive disease and six patients were steroid-unresponsive. The treatment was well tolerated and plasma half-life of CDP571 was approximately 7 days. There was a significant reduction from 6.7 to 4.6 (P = 0.023) in the mean Powell-Tuck score by 1 week post-infusion and a reduction to 5.5 was seen at 2 weeks (P = 0.218). Significant but modest reductions also occurred in erythrocyte sedimentation rate and serum C reactive protein in the first 2 weeks. Mean Interleukin-6 plasma concentrations fell from 6.9 to 5.4 pg/mL by week 1, and to 6.1 pg/mL by week 2 (NS). Reductions in sigmoidoscopic score and number of liquid stools were noted but failed to reach statistical significance. CONCLUSION: A consistent improvement in disease activity was seen in the initial 2 weeks after infusion and the treatment was well tolerated. These promising results support the testing of CDP571 in a larger controlled trial.

Adult↗

A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis.

BACKGROUND: Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine. AIM: To compare the safety and efficacy of balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity. METHODS: Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary. RESULTS: Fifty-seven patients were randomized: 28 to receive balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the balsalazide group due to adverse events (2/28 vs. 9/29, P=0.041). These data confirm that balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups. CONCLUSIONS: This study confirms the better tolerability of balsalazide compared to sulfasalazine, and supports the use of balsalazide in ulcerative colitis of all grades of severity.

Administration, Oral↗

Distal procto-colitis and n-3 polyunsaturated fatty acids: the mechanism(s) of natural cytotoxicity inhibition.

BACKGROUND: Altered natural killer (NK) and lymphokine-activated killer (LAK) cell activities have been reported with ulcerative colitis (UC). Previously, we have shown that in patients with UC, the n-3 polyunsaturated fatty acids (PUFAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), specifically inhibit natural cytotoxicity with clinical improvement in disease activity. The aim of this study therefore was to evaluate the possible mechanism(s) involved in this inhibition, and in particular the alteration of production of interleukin 2 (IL2) and the arachidonic acid metabolite leukotriene B4 (LTB4), both known to modulate NK cell activity. MATERIALS AND METHODS: Each patient with procto-colitis received either fish oil extract (EPA 3.2 g, DHA 2.4 g; n = 9) or placebo (n = 9) daily for 6 months. Monthly assessment included disease activity using clinical and sigmoidoscopic scores. Peripheral blood mononuclear (PBMN) cells were isolated and NK cell cytotoxic activity in vitro was measured. Monthly serum samples were analysed for LTB4, IL2 and soluble IL2 receptors (sIL2R). RESULTS: The n-3 PUFAs group had significantly reduced NK cell activity, compared with the placebo group (P < 0.05, Mann-Whitney U-test). In the n-3 PUFA group, incubation of PBMN cells for 72 h with recombinant interleukin 2 (rIL2) reversed the NK inhibition. In patients with active proctocolitis, serum levels of LTB4 correlated positively with NK cell cytotoxicity (r = 0.873, P < 0.05, Kendall's correlation coefficient). After six months of n-3 PUFAs supplementation, serum levels of LTB4 were undetectable with concurrent significant reduction in NK cell cytotoxic activity. The latter was associated with significant reduction of serum IL2 and sIL2R levels (P < 0.05). CONCLUSION: This study has demonstrated both evidence of suppression of immune reactivity and concurrent reduction in disease activity in patients with proctocolitis receiving n-3 PUFAs supplementation. This may have important implications for therapy in patients with UC.

Cytotoxicity, Immunologic↗

Compliance and findings in a Swedish population screened for colorectal cancer with sigmoidoscopy.

AIM: The aim of this study was to evaluate the patterns of compliance and the frequency of adenomas and neoplasms in a Swedish population. METHODS: In 1996, 2000 men and women born in 1935 or 1936 were selected at random from the population registers of Uppsala and Malmö/Lund. All subjects were invited by mail to participate. In a randomised study design, subjects were either called up by a nurse to schedule the appointment for sigmoidoscopy or instructed to call themselves. At sigmoidoscopy subjects with a cancer, an adenoma (neoplastic polyp) or more than three hyperplastic polyps were scheduled for a complete colonoscopy. RESULTS: Thirty-nine percent (770/1988) of all the invited subjects had a sigmoidoscopy. The participation differed between the two centres, 47% at the Uppsala centre and 30% at the Malmö/Lund centre (P<0.01). There was no statistically significant difference between the two different invitation groups. In all, 98 subjects (13%) were planned for colonoscopy. Thirty-one (35%) of the subjects having a colonoscopy were women and 57 (65%) were men. Fifty-five true adenomas were found in 46 subjects. All together, six subjects had proximal adenomas. Five adenocarcinomas were diagnosed, all within the reach of the sigmoidoscope. CONCLUSIONS: The compliance was lower and the adenomas were fewer than expected. To increase compliance it is necessary with rigorously controlled invitation routines.

Adenoma↗

Cancer incidence in the Falkland Islands.

Cancer incidence in the Falkland Islands, 1989-2000, was compared with rates in England and Wales, from which most Islanders originate. Colon and rectum cancer incidence was significantly raised 1989-93 but greatly reduced after 1994, when colonoscopic screening in high-risk families and sigmoidoscopic screening in the general population were introduced.

Colonic Neoplasms↗

[Anastomotic protection with a transanal tube after rectum resection and total mesorectal excision].

Between October 1998 and December 1999 50 patients with a primary cancer of the rectum were treated by sphincter saving anterior resection of the rectum and total mesorectal excision. Eight patients were given a neoadjuvant combined radio-chemotherapy. The anastomoses were performed in the triple-stapling technique with a Premium Plus CEEA stapling device (Fa. Tyco Health Care, Tönisvorst, Germany) or with a Proximate ILS curved stapling device (Fa. Ethicon Endo Surgery, Norderstedt, Germany). The anastomoses were situated in 7 cm or in lower distance from the anal skin. In all patients with complete anastomotic tissue rings the anastomoses were protected with the transanal tube. The integrity of the anastomosis (n = 48) was checked for completeness in the 2nd and 12th postoperative week. The patients were sigmoidoscoped and the anastomoses were controlled by transanal ultrasonography. During the hospital stay 2 patients (4.2 %) with a clinically evident anastomotic leakage were detected. 3 patients (6.2 %) with an asymptomatic anastomotic leakage were detected by computertomography. The anastomoses of 27 patients (56.2 %) were clinically and by ultrasonographical examination intact. In these patients a postoperative radiogram was not indicated. Relaparotomy was necessary in one patient for bleeding, in two patients for anastomotic leaks and in three patients for ileus (12.5 %). Because of low anastomotic leakage rate and low morbidity we find the transanal tube to be at least equivalent to conventional colostoma for anastomotic protection.

Adult↗

Does scant hematochezia necessitate the performance of total colonoscopy?

BACKGROUND AND STUDY AIMS: Controversy exists as to whether all patients with lower intestinal bleeding need to undergo total colonoscopy. This study compares the prevalence of colonic neoplasms in patients reporting scant hematochezia with the prevalence in controls. PATIENTS AND METHODS: Structured interviews were carried out with 4265 consecutive patients referred for colonoscopy. Of these, 468 patients had scant hematochezia, 299 had occult rectal bleeding and 57 reported dark rectal bleeding. Patients with scant hematochezia were matched for age and sex with those having no risk factors for colorectal neoplasms. For all groups, we determined the prevalence of adenomas and cancers below and above 50 cm. RESULTS: Colonic neoplasms were found in 18 % of patients with scant hematochezia and in 7.5 % of controls. However, most of these tumors were located within the reach of a sigmoidoscope. Compared with controls, patients with scant hematochezia had no increased risk for proximal neoplasms (odds ratio [OR] = 1.2), while this risk was significantly increased in patients with occult rectal bleeding (OR = 3.1) and patients who had observed maroon-colored blood in their stool (OR = 4.8). CONCLUSIONS: Flexible sigmoidoscopy appears to be a sufficient work-up for young patients who have observed trace amounts of bright red blood on the surface of their stool.

Adenoma↗

The Aer-O-Scope: proof of the concept of a pneumatic, skill-independent, self-propelling, self-navigating colonoscope in a pig model.

BACKGROUND AND STUDY AIMS: Considerable training is needed to enable endoscopists to use the currently available commercial colonoscopes and sigmoidoscopes effectively and safely. The aim of this study was to evaluate the safety and efficacy of the propulsion mechanism incorporated into the Aer-O-Scope (GI View Ltd., Ramat Gan, Israel)--a novel self-propelled, self-navigating colonic endoscope for diagnostic purposes. MATERIALS AND METHODS: Twenty young female pigs underwent complete bowel preparation followed by a sedated examination using the new device. Ten pigs underwent two consecutive procedures, with a wash-out period of 7 days between each procedure. The total number of procedures was 30. Two prototypes of the Aer-O-Scope, with different cable lengths and vehicle balloon sizes (n = 20 and n = 10 for prototypes I and II, respectively) were used. Each examination was followed by a standard colonoscopy for safety evaluation. The insertion length of the Aer-O-Scope was determined by fluoroscopy images. RESULTS: The colon was adequately clean in 25 procedures. Maximum insertion was achieved in 21 procedures (84%)--80% with prototype I (n = 15) and 90% with prototype II (n = 10). The time to maximum insertion averaged 8.9 +/- 4.4 min (10 +/- 4.6 and 6.6 +/- 2.9 min for prototypes I and II; P < 0.05), and the withdrawal time averaged 3.4 +/- 2.1 and 4.2 +/- 3.4 min, respectively. The driving pressures for prototypes I and II averaged 46.3 and 34.5 mbar, respectively. The follow-up conventional colonoscopy identified no mucosal tears or perforations. Minor mucosal petechiae were noted in 43% of the cases. No adverse events were noted up to 7 days after the procedure. CONCLUSIONS: The propulsion mechanism used in this novel self-propelled, self-navigating colonoscope was effective and safe in pigs.

Animals↗