Multi-center Clinical Trials About Botulinum Toxin Type A Anal Sphincter Side Injection And Lesions Expanding Sector Cut A Small Incision Drainage In The Treatment â…¡, â…¢ Anal Fissure

Objictive:Based on the pre-clinical studies in the center, multi-center clinical trial proved again that botulinum toxin type A anal sphincter side injection and lesions expanding sector cut a small incision drainage in the treatment II, III anal fissure in the safety and effectiveness, to improve and perfect the steps and key points of the operation, and to provide a new method to optimize treatment options for anal fissure.Method:The paper use the design of complete random and multi-center clinical study. It’s collaborative completed by the Second Affiliated Hospital of Hunan Medical University, People’s Liberation Army163Hospital, Hospital of Changsha City.A total of120patients met the study criteria were randomly divided into two groups (botulinum toxin type A anal sphincter side of injection lesions fan small incision cut to expand the drainage) and control group1(fan-shaped lesions small incision cut expansion drainage part of the sphincterthe side of the amputation), control group2(anal fissure excision debridement amputation surgery part of the internal sphincter side), the allocation rate is1:1:1for three groups of cases. By observing the wound healing time, postoperative pain scores and the occurrence of postoperative complications and other observed indicators, the paper combined with anorectal manometry to evaluation of anal function.Result:Three experimental groups did not occurre about incontinence and acute urinary retention. The result of the comparison for postoperative recovery rate:botulinum toxin type A anal sphincter side injection and lesions expanding sector cut a small incision drainage are better than the other groups, p<0.05.Pain integral results:the pain integrals of surgery after24h, the first bowel movement and a week after surgery pain were lower than the other groups for botulinum toxin type A anal sphincter side injection and lesions expanding sector cut a small incision drainage p<0.05.the difference between two comparison groups has no significant,p>0.05. anorectal manometry test results:all isndicators in the three groups before surgery have no statistically significant difference, p>0.05. Changes of the postoperative anal resting pressure were statistically significant, Panal <0.01. preoperative and postoperative differences have no statistically significant among the pressure of anal canal maximum systolic,rectal sensation capacity and rectal maximum capacity (P>0.05);the healing time of observed group is shorter (P<0.05) than the others.while the difference between the two groups was no statistically significant (P> 0.05).Conclusions:The study have some advantages through the compare between conditional control group and experimental group:the healing time of surgical wound is short, the small size of scars, less pain, quick operation and maximum protection for internal anal sphincter and so on. And on the basis of preliminary studies, it optimizes the surgical procedure and reduces the difficulty of surgery to improve surgical accuracy. In this study, the clinical efficacy of the technique both good and a higher security, it’s worthy of clinical application.