研究疾病:
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陈旧性肛裂
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研究疾病代码:
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K60.101
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Target disease:
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old anal fissure
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本项目拟以肛肠病安氏疗法采用精准比例切口设计的方式对陈旧性肛裂进行治疗的手术方法为研究对象,通过与对照组进行观察研究,主要将手术前后肛门功能评价、创面面积、创面愈合率、创面愈合时间、创面水肿、创面疼痛、术后排尿障碍、治疗效果、复发率等作为观察指标,开展前瞻性、随机、平行对照的临床研究,拟将符合入选标准的患者采用随机方法,观察组与对照组病例数按1:1分配,通过研究,以期对肛肠病安氏疗法采用精准比例切口设计的手术方式对陈旧性肛裂进行治疗的手术方法的科学性进行评价。
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Objectives of Study:
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The objective of this study was to investigate anorectal diseases treated with Anns method using precise proportion incision design for old anal fissure, the evaluation of anal function, wound area, wound healing rate, wound healing time, wound edema, wound pain, postoperative dysuria, therapeutic effect and recurrence rate were used as observation indexes, to carry out a prospective, randomized, parallel control clinical study, the selection criteria of patients to adopt a random method, the number of cases in the observation group and the control group according to 1:1 distribution, through the study, the aim of this study is to evaluate the scientific method of anorectal diseases treated with Ann's method using precise proportion incision design for old anal fissure.
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药物成份或治疗方案详述:
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本方案将2021年10月至2023年9月在我院及合作医院肛肠科住院符合纳入标准的陈旧性肛裂患者,共102例,采用随机数字表法随机分为治疗组和对照组,各51例。治疗组采用肛肠病安氏疗法精准比例切口设计的手术方式,具体术式名称为病理组织切除、内括约肌松解术,治疗陈旧性肛裂,对照组采用肛裂切除术治疗陈旧性肛裂。通过对两组患者手术前后肛门功能评价、创面面积、创面愈合率、创面愈合时间、创面水肿、创面疼痛、治疗效果、复发率等指标的观察,使用 SAS 9.2软件进行统计学处理,综合评价肛肠病安氏疗法采用精准比例切口设计的手术方式治疗陈旧性肛裂的科学性。
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Description for medicine or protocol of treatment in detail:
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A total of 102 patients with old anal fissure who were admitted to the Department of Anus and intestine of our hospital and cooperative hospitals from October 2021 to September 2024 were randomly divided into treatment group and Control Group (51 cases each) .In the treatment group, the precise proportion incision was used for old anal fissure, the name of the operation was pathological tissue resection and internal sphincter release, the control group was treated with excision of anal fissure for old anal fissure. Through the evaluation of anus function, wound area, wound healing rate, wound healing time, wound edema, wound pain, treatment effect and recurrence rate of two groups of patients before and after operation, statistical analysis using SAS 9.2 software, Comprehensive evaluation of Anorectal Diseases Ann's therapy using precision proportion incision design of surgical treatment of old anal fissure of the scientific.
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纳入标准:
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1.年龄≥18 岁≤65 岁,性别不限;
2.符合陈旧性肛裂诊断标准;
3.发病后未接受肛裂手术者;
4.患者自愿参加本研究并签署知情同意书。
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Inclusion criteria
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1. Age ≥18 years ≤65 years, sex is not limited;
2. Meet the diagnostic criteria of old anal fissure;
3. Those who do not undergo anal fissure surgery after onset;
4. The patient voluntarily participated in the study and signed an informed consent form.
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排除标准:
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1.合并肿瘤者;器质性心脏病,或心律失常者;有肝、肾、肺、造血系统等严重原 发性疾病者,或肝功能异常,AST、ALT 大于正常值 1.5-2 倍,肌酐大于正常值上限者;或 严重代谢、胃肠、内分泌功能紊乱者;
2.拟怀孕、怀孕或哺乳期的女性;
3.有出血倾向者;
4.有精神疾患无法合作者;
5.滥用药物、毒品或酗酒史者;
6.主要脏器外科手术后未满 6 周患者,手术伤口愈合不良患者;
7,有免疫缺陷病史,包括 HIV 检测阳性或患有其它获得性、先天性免疫缺陷疾病者;
8.处于急、慢性结核感染期间者。
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Exclusion criteria:
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1. Patients with tumor, organic heart disease or Arrhythmia, patients with liver, kidney, lung, hematopoiesis and other serious diseases, or abnormal liver function, AST,ALT 1.5-2 times higher than normal, creatinine higher than the upper limit of normal; Or serious metabolic, gastrointestinal, endocrine disorders;
2. A woman who is getting pregnant, pregnant, or nursing;
3. Prone to bleeding;
4. Unable to cooperate with others due to mental illness. A history of drug, drug, or alcohol abuse;
5. Patients with poor wound healing less than 6 weeks after Major Organ Surgery;
7. Have a history of immunodeficiency, including HIV testing positive or with other acquired, congenital immunodeficiency disease;
8. In the acute, chronic tuberculosis infection period.
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研究实施时间:
Study execute time:
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从From
2021-10-01
至To
2024-09-30
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征募观察对象时间:
Recruiting time:
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从From
2022-07-21
至To
2024-09-30
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