| The high intersphincteral anal fistula(HIAF)is classified according to the Parks criteria.It originates from the affected area of anal gland infection.The fistula runs along the gap between the internal and external sphincter muscles,penetrates the skin outward to form an external orifice,and extends inward along the internal and the gap between the superficial and deep parts of the external sphincter muscle.Its end reaches up to the musculus levator ani.Because it penetrates through the anorectal ring,how to protect the anal function while opening the fistula to cure it during surgery is a clinical challenge.How to improve the success rate of HIAF surgery,decrease the recurrence rate,alleviate postoperative pain,reduce postoperative complications while protecting anal function,avoiding anal function damage and improving the quality of life of patients,has been a difficult problem in the treatment of HIAF.There is no unified standard for the treatment of HIAF at both home and abroad.Therefore,we anorectal specialists have been attempting to explore the appropriate therapeutic method at advantages of favorable efficacy,mild pain,low recurrence rate,maintenance of anal function,and improvement of quality of life of patients.In this paper,on the one hand,the loose combined cutting seton was used to treat HIAF by clinical observation method.To be specific,the effectiveness and safety were evaluated in the loose combined cutting seton referring to silk-ligating,no stringing after surgery,and removing suture after 20 days compared with the traditional cutting seton in order to analyze the observational indices of effectiveness including clinical efficacy and recurrence rate and the safety evaluation indices such as anal function assessment and anorectal pressure measurement by comparing the postoperative pain degree.On the other hand,fistula model was constructed in animal experiments,which was intervened by the loose combined cutting seton in order to explore establishment method of fistula model and mechanism of anus fistula treated by the loose combined cutting seton.Clinical StudyEffectiveness and Safety of the application of loose combined cutting seton in the treatment of HI AFObjective To evaluate the effectiveness and safety of loose combined cutting seton in the treatment of HIAF when comparing with cutting seton in a clinical randomized controlled study.Create a new surgical method for the treatment of HIAF.Compared with the cutting seton,advantages such as clinical efficacy,recurrence rate,postoperative complications reduction,course of treatment shortening,and anal function protection were evaluated using loose combined cutting seton.Methods This study is a prospective,single-blind,randomized,controlled,non-inferiority clinical trial.72 patients with clear diagnosis of HIAF in the outpatient clinic and they were agreed for surgeries.The random distribution card is sealed in a numbered,opaque kraft paper envelope.Open the envelope according to the order of patient visits and meet the inclusion criteria.Group A was the experimental group(36 cases),and Group B was the control group(36 cases).In the experimental group,loose combined cutting seton was used;in the control group,cutting seton was used.The general observations such as baseline data,general preoperative routine examinations,clinical therapeutic indices including cure rate,recurrence rate,and wound healing time,and safety evaluation indices such as postoperative pain visual analogue scale(VAS)score,anorectal pressure measurement,WENER anal function evaluation,and anal appearance were recorded and calculated in the two groups.Results 34 cases were both completed in the experimental group and the control group.Before treatment,there were no statistical differences in baseline data including gender,age,height,body weight,preoperative main symptoms,and anal function measurements before surgery including anal resting pressure,anal maximal contraction pressure,and high pressure zone length,which are comparable(p>0.05).After treatment,with regard to effectiveness evaluation indices,the cure rate in the experimental group was 91.18%,and 85.29%in the control group without statistical difference between the two groups(p>0.05).There was no recurrence case observed in the experimental group after follow-up,while the recurrence rate in the control group was 2.94%,and the difference was not statistically significant(p>0.05).The average healing time in the experimental group was 41.74±8 days,while in the control group,the average healing time was 51.27±11.77 days,and the difference was significant(p<0.05).The postoperative anal pain VAS score in the experimental group no significant difference on 1st day day(p>0.05)and was lower than the control group on 7th?14th?20th days,with a statistical difference(p<0.05).In the experimental group,there was no anal incontinence case;in the control group,there were five patients scored>10 points on anal incontinence by Wexner function.The functional score after surgery in the experimental was lower than that of the control group with statistical significance(p<0.05).Anorectal pressure measurement results showed that there was no significant difference in postoperative anal resting pressure between the experimental group and the control group(p>0.05).The postoperative anal maximal contraction pressure was higher than that of the control group,and there was a significant difference between the two groups(p<0.05).The high pressure zone length in the experimental group was higher than that of the control group,and the difference was statistically significant(p<0.05).Conclusion The loose combined cutting seton for the treatment of HIAF can obtain a definite effect in a low recurrence rate.It is superior to the traditional cutting seton in alleviating postoperative pain,promoting wound healing,protecting anal function,and preventing anal incontinence.Experimental study1.Study of anal fistula model with silk-ligating for drainageObjective To construct an anal fistula model in rats,explore the possibility of a silk-ligating model a.Methods Thirty Sprague-Dawley(SD)rats were adaptively raised for 7 days and randomly divided into the normal group(n=10),experimental group(n=10)and control group(n=10).In the experimental group,perianal silk was indwelled,and in the control group,metal thread for ligation was indwelled.The general conditions,anal temperature,changes in perianal secretions,and hematoxylin-eosin(H&E)staining of perianal tissues after sampling were observed.The content of inflammatory cytokines including interleukin-4(IL-4),transforming growth factor-?(TGF-?),IL-6,and tumor necrosis factor-?(TNF-?)in anal fistula tissues was tested using enzyme-linked immunoabsorbent assay(ELISA).Results With regard to the general conditions of rats after modeling,the rats in the experimental group and the control group were relatively debilitated in less active compared with the normal group.Three rats died in the control group 5,10,and 13 days after surgery.There were no abnormal deaths in the normal and experimental groups.There was no statistical difference in the anal temperature of the experimental group,control group and normal group before modeling(p>0.05).The average anal temperature of the experimental group increased on the 1st day after modeling,compared with the normal group(p<0.05).The average anal temperature in the control group increased compared with the normal group(p<0.05).The difference in anal temperature between the experimental group and the control group was not statistically significant(p>0.05).On the 7th day,the average anal temperature in the experimental group was higher than that in the normal group(p<0.05).The average anal temperature in the control group was higher than the normal group(p<0.05).The average anal temperature in the experimental group was lower than the control group(p<0.05).On the 14th day,the average anal temperature of the experimental group was higher than that of the normal group,and the difference was statistically significant(p<0.05).The anal temperature of the control group was higher than the normal group,with a significant difference(p<0.05).The anal temperature was lower in the experimental group than the control group,and the difference was significant(p<0.05).There was no statistical difference in the anal temperature of the experimental group,control group,and normal group on the 21st day(p>0.05).On the 30th day,there was no significant difference in anal temperature in these three groups(p>0.05).On perianal secretion scores in rats,there were secretions around the anus after modeling in the experimental group and the control group.There was no significant difference in the scores of the perianal secretions between the two groups on the 1st day of the modeling(p>0.05).The peripheral secretions significantly decreased compared with the control group on the 7th day,and the difference was significant(p<0.05).The perianal secretions in the experimental group still decreased on the 14th day,which was significantly different from that of the control group.The perianal secretions gradually reduced on the 21st day and no significant difference was displayed between the two groups(p>0.05).On the 30th day,the perianal secretion gradually decreased,and there was no significant difference between the two groups(p>0.05).H&E staining of perianal tissues after sampling,obvious anal fistula-like changes were observed under microscope in the experimental group and the control group,and the successful modeling rate of the experimental group was higher than that of the control group,with a statistical difference(p<0.05).On the content of inflammatory cytokines in tissues,the levels of inflammatory cytokines including IL-4,TGF-?,IL-6,and TNF-? after modeling in the perianal tissue of the experimental group and the control group were higher than those in the normal group,and the differences were significant(p<0.05).The levels of IL-4 and TGF-? in the perianal tissue of the experimental group were higher than those in the control group,and the differences were significant(p<0.05).The levels of IL-6 and TNF-? in the perianal tissue of the experimental group were lower than those in the control group(p<0.05).The levels of healing factors including VEGF and FGF-2 in the experimental and control groups were higher than those in the normal group,and the difference was statistically significant(p<0.05).The levels of VEGF and FGF-2 in the experimental group were lower than those in the control group with statistical significance(p<0.05).Conclusion The anal fistula model of rat was successfully established by indwelling anus with silk-ligation.The actual success rate was higher than that of the metal thread seton published in previous literatures.The local anal inflammatory response may be one of the possible mechanisms of anal fistula.2.Experimental study of anal fistula treated with loose combined cutting setonObjective To study the therapeutic effect of anal fistula model in rats with loose combined cutting seton,and explore its mechanism in treating anal fistula.Methods In this experiment,grouping was conducted twice.First,30 SD rats were divided into normal group(n=6)and model group(n=24).After modeling,they were randomly divided into the blank group(n=8),experimental group(n=8),and control group(n=8).In the experimental group,loose combined cutting seton using silk was used,and in the control group,cutting seton using rubber band was applied.The general conditions of the rats,anal temperature,and the changes of the perianal secretions were observed.The levels of the healing factors of VEGF and FGF-2 in the perianal tissue of the rats were detected by immunohistochemistry and Western-Blot.The immunohistochemical integrated optical density(IOD)values and Gray values were measured using Image-pro plus 6.0 analysis software(Media Cybernetics,Inc.,Rockville,MD,USA).The content of inflammatory cytokines including IL-4,TGF-?,IL-6 and TNF-? in serum and perianal tissue were tested using ELISA.Results After the modeling,there were statistical differences in the general conditions,perianal secretion,the levels of VEGF and FGF-2,and the content of inflammatory cytokines including IL-4,TGF-?,IL-6,TNF-? between the control group and the blank group with significant differences(p<0.05).No obvious difference in the average anal temperature was displayed between the control group and the blank group(p>0.05).On the general conditions of rats,there were significant differences in the experimental group and control group compared with that in the blank group after intervention,presenting with debilitation,lusterless hair,reduced activity,poor food and water intake,no abnormalities of defecation and urination,and absence of abnormal death.On measuring anal temperature,there was no statistical difference in the average anal temperature of the experimental group,the control group,and the blank group before intervention(p>0.05).The average anal temperature of the experimental group and the control group increased on the 1st day after the intervention.The average anal temperature of the experimental group was statistically different from that in the blank group(p<0.05).The average anal temperature of the control group was significantly different from that of the blank group(p<0.05).The average anal temperature was not significant between the experimental group and the control group(p>0.05).On the 4th day,the anal temperature of the experimental group was higher than that of the blank group(p<0.05).The average anal temperature of the control group was higher than that of the blank group(p<0.05).The average anal temperature of the experimental group was lower than that of the control group(p<0.05).The average anal temperature of the experimental group was higher than that of the blank group on the 7th day(p<0.05).The average anal temperature of the control group was higher than that of the blank group(p<0.05).The average anal temperature in the experimental group was lower than that in the control group,and the difference was statistically significant(p<0.05).With regard to perianal secretion in rats,there was no statistical difference in perianal secretion score before intervention in the experimental group and the control group compared with that in the blank group(p>0.05).Compared with the blank group,the perianal secretion score increased on the 1st day after intervention in the experimental group(p<0.05).The perianal secretion score in the control group increased also compared with the blank group,and the difference was significant(p<0.05).There was no significant difference in the perianal secretion score between the experimental group and the control group(p>0.05).The secretion score of the experimental group increased on the 4th day,compared with the blank group(p<0.05).The secretion score of the experimental group was higher than that of the control group with statistical significance(p<0.05).The secretion score of the control group increased compared with that in the blank group with a significant difference(p<0.05).The secretion score on the 7th day was higher than that of the 4th day in the experimental group,and the difference was significant compared with that in the blank group(p<0.05).The secretion score in the experimental group was lower than that of the control group on the 7th day,and there was a significant difference between the two groups(p<0.05).The perianal secretion score of the control group was significantly different from that of the blank group(p<0.05).On the serum levels of inflammatory cytokines,the content of serum inflammatory cytokines including IL-4,TGF-?,IL-6,and TNF-? in the experimental group and the control group were higher than those in the blank group after intervention,and the differences were statistically significant(p<0.05).The serum levels of IL-4 and TGF-? in the experimental group were higher than those in the control group with statistical significance(p<0.05).The serum IL-6 level in the experimental group was lower than that in the control group,and the difference was statistically significant(p<0.05).Compared with the control group,the TNF-? content in the experimental group was not significantly different(p>0.05).On the content of inflammatory cytokines in tissue,the levels of inflammatory cytokines including IL-4,TGF-?,IL-6 and TNF-? in the perianal tissue of the experimental group and the control group were higher than those in the blank group after the intervention with statistical significance(p<0.05).The levels of IL-4 and TGF-? in the perianal tissue of the experimental group were higher than those in the control group,and the differences were significant(p<0.05).The levels of IL-6 and TNF-? in the experimental group were lower than that in the control group,and the differences were statistically significant(p<0.05).On tissue levels of inflammatory cytokines,the levels of healing factors including VEGF and FGF-2 in the experimental and control groups were higher than those in the blank group,and the difference was statistically significant(p<0.05).The levels of VEGF and FGF-2 in the experimental group were higher than those in the control group with statistical significance(p<0.05).On tissue levels of Western-Blot,the levels of VEGF protein and FGF-2 protein in the experimental and control groups were higher than those in the blank group,and the difference was statistically significant(p<0.05).The levels of VEGF protein and FGF-2 protein in the experimental group were higher than those in the control group with statistical significance(p<0.05).Conclusion Loose combined cutting seton obtains remarkable effects on drainage and tissue healing after anal fistula surgery.Regulation of the content of inflammatory cytokines and the level of healing factors may be one of its mechanisms for the treatment of anal fistula. |
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