| Background and Purpose:As the most preferred low colorectal cancer surgical procedures, the Miles rectal cancer surgery(abdominal perineal resection colorectal cancer),is an important part of the colorectal cancer surgery. According to statistics, the rectal cancer morbidity in our country is25-35people/10million, among them30%is due to the location of the tumor is too low and had to cut the anus. According to the estimation of the China Ostomy Association chairman Dehong Yu, China’s new permanent annual increase intestinal stoma patients about10million people, a total of100colostomy those people, there is an increase trend in the future.Colostomy patients is a special group, the colostomy complications are difficult to manage, and the traditional colostomy bag would cause great impact on patient’s mental health, and the traditional method of colostomy management isn’t ideal. In order to solve the above problems, a lot of artificial anal plugging devices have been developed at home and abroad, but from the point of view of its bowel control is nothing more than two categories, one is to use a block device or an external device intestinal stoma closure or mouth acceptance of the stool, defecation block devices (such as ostomy, colostomy suppository, etc.) need to be entirely or partially removed during defecation; Another is to simulate anal sphincter, the lateral force blocks the artificial anus and artificial intestinal anal contraction, and withdraw externally applied forces during defecation, so that the artificial mouth or anus bowel colostomy will open (such as the U.S. ABS artificial anus, Britain developed the artificial anal sphincter and Germany PAS highly integrated artificial anal sphincter, etc.). Clearly, the former needs to remove the plugging device, which is troublesome and unhealthy, and will have impact on the skin around the stoma and mental health of patients. The latter simulates anal sphincter to ensure that the blocking effect needs to exert greater pressure on the intestinal wall, easy to produce intestinal lesions due to ischemia. Based on this, the development of a safe and effective means of controlling artificial anus has become an urgent need.This experiment mainly study different pressure intelligent artificial anus plugging device sealing effect and the animal experiments. This test of different pressure intelligent artificial anal plugging device control device, using organic silicone rubber. Because intelligent colostomy closure device is large, and requires close to human physiology, we use miniature pigs as experimental subjects. After the establishment of animal models colostomy, applying pressure from the sealing device to explore the direction of the intestine through the stoma leakage observed case, the general concept of stoma, inflammatory infiltration. Explore the intelligent artificial anus plugging device optimal pressure range when using least complications.Research Contents and Methods:1. Intelligent artificial anal plugging device model1.1Set the default program:refer to the domestic and foreign references.In the preliminary experiments measure the weight of about29kg experimental Tibet miniature pig colon lumen diameter size. As intelligent colostomy closure device model design dimensions, and thus And thus set the load project and map out the engineering drawing and dynamic simulation.1.2Materials:medical organic silicone rubber is quite a wide range of biological materials used in medical field, has good biocompatibility, non-irritating, non-toxic, non-allergic reactions, rarely body rejection to the tissue, and body fluids as well as tissue contact process can maintain its original elasticity and softness, not be degraded and the service life of the material can last for decades. Therefore, clinical trials on this selection has been widely used and proven to have good biocompatibility of silicone rubber materials used for model making.1.3Model Making:select sample production unit, according to stereogram of the design scheme, engineering drawings, rapid injection molding, produce a plugging device model.1.4Determine the final model samples:The device includes artificial anal sphincter, and water sac two parts. The artificial anal sphincter is a Kind of hollow cylindrical substance with a height of about7cm and5cm in diameter It’s made from organic silicone rubber, has a certain hardness and elasticity, placed in the abdominal wall or pelvic peritoneal fold less space rectum after excavation, which can stabilize and support intestinal canal. Sigmoid colon can through the center from artificial anal sphincter and be fixed. There are two openings from artificial anal sphincter at the base2cm and5cm bladders, which are located opposite side, used for water injection water sac expansion closed loops. Water sac buried within the artificial anal sphincter2side, a catheter connectted to pump, Through the pump to the sphincter after water injection water sac expansion, highlighting the artificial bowel sphincter compressed into an "S" closed intestine; After Withdrawing water pump capsular retraction, bowel natural expansion. To open defecation in patients with fecal discharge device to simulate the role of the human anus, so that patients regain the ability to control bowel movements. 2. Colostomy model All Tibet mini-pigs environmental adaptation three days in advance before experiment, preoperative fasting24h, the fasting period can be appropriate to give glucose, electrolyte solution, forbidden to drink8h. Set small pigs colostomy models according to the extraperitoneal colostomy after the completion of preoperative preparation.3. Animal experiments Research of different intelligent pressure sealing device for the on the effects of colostomy complications3.1Stoma leakage rate After the8.42mmHg,18.05mmHg and33.33mmHg three different pressure control device is closed, count the number of colostomy leakage times of each group animals in the1,2,4,6weekend day2h after eating (Through the artificial colostomy into dilute barium, after blocking observed by eating within2h after angiography contrast agent leaks).3.2Histological observation (a) General observation of colostomy local bowel ischemia, necrosis and incision infection status of surrounding tissue (b)2. before the closure, post-closure1,2,4,6gripping each weekend a small group of animals stoma intestinal mucosa, line formalin fixed, HE staining, counting40high magnification tissue neutrophils, lymphocytes absolute value.3.3intestine local perfusion Animals were fixed after anesthesia, set the channel zero, the needle probe with the intestinal wall placed perpendicular from the distal stoma at2cm to each group before plugging perfusion as a baseline., Close the artificial anus control device and record the blood flow after closing time for6s,60s,1h and6h. 4. Statistical analysisSince the types of test observations and the factors influencing the relative complexity, so do targeted statistical design as follows:Stoma leakage rate data:balloon pressure affect the focus be analyzed using the chi-square test overall and partition, resolve the distribution of different balloon pressure during the test three groups of stoma leakage rate, indirect analysis of ostomy bag pressure leakage rate impact.Neutrophils and lymphocytes Information:The data for the two factors that affect data:balloon pressure factors and test the overall process time factor, the latter of which is the nature of the repeated measurements factors,so the design is two-factor repeated measures analysis of variance, respectively the impact of various factors and the interaction of two factors make the determination.Partial intestinal perfusion:There are three factors which influence:Different balloon pressure groups, different tests and different total process time off colostomy time. Therefore, a comprehensive analysis will be conducted three factors. To simplify the statistical process, the three factors that are considered to be independent factors, ignoring the different time and a different test colostomy closure time pairing of these two factors is the nature of homogeneous sources. Designed as two (three) factors split plot trials. Where:Different balloon pressure is the most important factor in this trial concerns the design of the cell; different colostomy closure time is an important factor as the times set in a large area, and then split the region from the region set of factors, that is, different The total process time factor test, which carried out the primary and secondary have other multi-factor analysis.Statistical software SPSS17.0, taking significant level α=0.05.Result 1Impact on stoma complications of different pressure intelligent artificial anus plugging device1.1Animal general statusThroughout the test, most test animals showed an excellent performance, but the maximum set pressure of the airbag group showed a poor performance, the intake, the activity deteriorates and weight decrease than the other two groups, the weight of each group before and after test were:B1group:28.2±1.0,28.3±2.1; B2group:27.3±1.0,28.2±0.8; B3group:29.0±1.3,24.1±2.0, respectively. Obviously B3group (maximum balloon pressure group33.33mmHg) decrease most weight, before and after its test weight difference was-4.9±1.9, paired t test to know:t=5.77, p=0.004, extremely significant.1.2stoma leakage rateLeakage total times and total number were highest in B1group, B3group was the lowest. Using a chi-square test to unclose the difference of leakage rate among three groups, B3group and B1, B2difference was statistically significant or near significant. Although this test only shows that the number of leaks in the distribution of the various periods of the total test process, but the combination of data can still be accurately concluded:leak rate decline with the balloon pressure increasing. When the balloon pressure rose18.05mmHg (B2group), the total number of leak only only one (also only once, and is a slight leak), and the highest balloon pressure group (B3group) similar.1.3Histological observation-neutrophils, lymphocytesBetween three different balloon pressure group, the five time point in the testing process and interaction between balloon pressure and test time, all p<0.01, there was a significant statistical significance. Binding data view:the number of lymphocytes and neutrophils, raised with bladder pressure increasing and the time going during the test.1.4Comparison of intestinal perfusion Blood flow in8.42mmHg group had no significant decline in comparison with baseline, resumed when6min,60min to return to the first level before plugging,18.05mmHg and33.33mmHg group blood flow decreased rapidly in the6s after block, when to60s under bottoming, after6min18.05mmHg group blood flow gradually began to recover,33.33mmHg group recovery trend is not obvious, and continued at a low level.Conclusion:1The intelligent artificial anal plugging device designed and produced by us using for small pigs animal studies, and the correlation between stress and stoma closure complications were discussed.2when the diameter of the control device bladders inside diameter was1/2(bowel pressure of about18mmHg), able to combine the leakage rate and complications at least the minimum balance. |
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