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Clinical report


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Clinical report

  1. 1. Papers on Clinical Application (LG 2000 Anorectal Treating Device Series) ZHENGZHOU SAFUTE ELECTRONIC EQUIPMENT CO., LTD. ADD: No.8 Guohuai Street, High & New Zone, Zhengzhou, China TEL: +86 371 67897033 FAX: +86 371 67897036
  2. 2. Observations on Curative Effects of Anorectal Diseases Treated by LG2000B Anorectal Treating Device People’s Hospital of Henan Province Feng Bei, Zhu Chongguang Abstract: The aim is to observe treatment effect and security of LG2000B anorectal treating device. For 330 cases, the curative effect is 99.14%, total effective rate is 100%. Besides, its advantages are easy operation, instant treatment, little suffering, little trauma, low expenses, no complications, no infection, no side effect, and fine long-term curative effect. Keywords: anal diseases; LG2000B anorectal treating device As clinical common and frequently encountered diseases, anal diseases make patients suffer a lot physically and mentally, severely affecting patients’ life, study and work. In recent years, since we brought in LG2000B anorectal treating device manufactured by Zhengzou Safute Electronic Equipment Co., Ltd., satisfactory curative effects have been reached in treating 300 cases with internal, external, anal abscess, anal fissure, etc. The whole process is summarized as follows: 1. Clinical data All together 330 cases in the group, 117 males, 223 females; max age is 76, mini 10; Types of disease: 157 external hemorrhoids, 148 internal, 49 anal abscess, 107 anal fissure; some patients suffer from two or three types Course of disease: 1-30 years 2. Case selection Diagnostic criteria: refer to criteria made at National Academic Conference on Coloproctology in 1975 2.1.1 Internal hemorrhoid Main symptoms: fresh red blood with defecation, or blood drop, or blood injection; induced or worsened by constipation, fatigue, drinking, and excessive rajasic food; anal prolapsus appears along with defecation, cough or squat; hemorrhoid nucleus come outside anus with or without pain Digital examination: soft convex with smooth surface, mucous membrane tuber without pressing pain; usually at 3, or 7, or 11 point in lithotomy position Anoscope inspection: tuber-shaped convex in mucous part under dentate line, forming into turgescence with dark purple or in the shape of strawberry. 2.1.2 External hemorrhoid Main symptoms: neoplasitc skin flap in the perianal with soft texture; no pain, no bleeding; a conscious feeling of foreign matter; painful when accidentally infected 2.1.3 Anal abscess Main symptoms: red, turgescent, hot and painful in the perianal, a callosity is formed; relatively heavier pain in local part; jumping pain; occasional chill, fever, and general malaise, etc. Page 2 of 9
  3. 3. Inspection: accessible painful lump with fluctuation when touched; liquor puris can be extracted via injector 2.1.4 Anal fissure Main symptoms: a little defecation with pain and blood; fresh red; sometimes attached to surface of defecation; blood drop at time; habitual constipation Inspection: anal fissure in gradeⅠ, skin of anal canal splits completely, forming into inflammatory ulcer, base of which is clean and trimmed, no complications or with a light anal sinusitis, inflammation of anal papilla; in gradeⅡ,base of ulcer is hoary, rim becomes thicker and untrimmed, undetermined texture, elasticity of anal canal lessened, remaining looseness, complications are sentinel pile, hypertrophy of anal papilla, anal sinusitis, etc.; in gradeⅢ, state of ulcer appears as in gradeⅡ with fibrosis, anal stenosis, complications are sentinel pile, hypertrophy of anal papilla and subcutaneous fistula, etc. 2.2 Intake standard: all those conforming to diagnostic criteria above 2.3 Exclusion standard: hypertension, hepatocirrhosis, patients suffering from hemorrhagic diseases, severe heart diseases, psychopathy and those in gestation period suckling period 3. Treatment method 3.1 Hemorrhoid Complete defecation before operation, local cleaning, take lithotomy or literal position according to morbid part, routine sterilization, anaesthetize by lidocaine of 1%, press electronic pincers, use tissue forceps to uplift upper part of hemorrhoid, use electronic pincers to clip its base(excessive inward clip of internal hemorrhoids should be avoided in case intestinal wall is injured); make sure it is well clipped, step on foot switch, the device sounds alarm automatically after 3-5 seconds which means treatment is finished, then take off pincers, cut residual tissues with pencil; for larger ones, cilp the tissue from different surfaces untill the hemorrhoid nucleus retreat with anus. 23 cases each time, after treatment, insert a piece of compound indomethacin suppositories into the anus; use aquae tepida to wash anus after defecation everyday and insert a piece of compound indomethacin suppositories so as to make defecation easy and smooth. 3.2 Anal abscess Preoperation preparations are as hemorrhoid, rutine strelization,local antisepsis, press eletronic pencil button, step on foot switch, cut morbid part with high frequency electronic pencers so as to discharge pus, then insert vaseline pledget, apply dressing to focus, cover and fix its position, clean the anus everytime after defecation. 3.3 Anal fissure: Preoperation preparations are as hemorrhoid, through excision of external sphincter muscle, rutine sterilization, treat in lithotomy position, local antisepsis, four fingers away from sphincter, press electronic pencil, step on foot switch, cut at 12cm in the perianal, at the centre behind anuas, 0.5-1cm or so under skin, use vessel forceps to pick up sphincter, then cut it off; if incision is 0.5cm, extrude two sides so as to match them; for bigger ones, bind them up after operation. 4. Curative effect 4.1 Standard: Refer to criteria made at National Academic Conference on Page 3 of 9
  4. 4. Coloproctology in 1975 Hemorrhoid Healing:36 months after treatment, it disappears when inspected through anoscope, no apparent scar exists,skin of anal canal and rectal mucous coat are smoth, no touch of callosity or ridgy mucous coat tissue, easy and smooth defecation, no blood with defecation; apparent effectiency: reduced hemorrhoid, no prolapsus of internal hemorrhoid, no blood with defecation; effeciency: part of hemorrhoid is reduced, no prolapsus of internal hemorrhoid, blood with defecation is decreased; Inefficacy: no change of clinical symptoms Anal abscess Healing: focus is eliminated, symptoms disappear; apparent effectiency: clinical symptoms get better obviously; effeciency: clinical symptoms are lessened; inefficacy: no change of symptoms 4.2 Consequence For all 451 cases, 447 are completely cured,taking up 99.14%; 4 cases with apparent effectiency, 0.86%. curative effects of different diseases are illustrated in the table below: Table Apparent Disease Case Healing(%) Effeciency Inefficacy Cure rate(%) effectiency(%) Internal 148 146(99.85) 2(1.42) 100 hemorrhoid External 157 157(100) hemorrhoid Anal 49 49(100) abscess Anal 107 105(98013) 2(1.87) 100 fissure 4.3 Side effect No side effect or complication are examined in all cases. 4.4 Follow-up No recurence for all 103 cases followed up. 5. Discussion 5.1 Anal diseases are clinical common and frequently encountered diseases. The morbidity is reported to be 59.1% in a national survey, of which, hemorrhoid taking up 52.19%. In the past, operation, injection, freezing, RF, laser, and far infrared are used to treat hemorrhoid, though certain effect can be reached, many defects like severe wound, long treatment course, high expense, great suffering also appear, making them hard to be accepted; injectin is just suitable for early internal hemorrhoid with high recurence, many complications; laser is restriced to epicanthus of external Page 4 of 9
  5. 5. hemorrhoid with limited application scope. LG2000B anorectal treating device is helpful to clinical usage with multiple functions, wide application scope, fine curative effect, particularly in the long term. 5.2 By adopting BEIM-biological electrical impedance automeasurement, LG2000B anorectal treating device assures tissue become dry and hard without carbonization; fine orientation performance; little trauma, light edema, no infection. 5.3 According to clinical inspection on 330 cases, treatment effects of internal and external hemorrhoid, anal abscess and anal fissure are satisfactory by using of LG2000B anorectal treating device. The cure rate is 99.14%, of which, external hemorrhoid and anal abscess are both 100%, internal hemorrhoid 98.58%, ana fissure 98.13%; apprent effenciency is 0.86%, of which, internal is 1.41%, anal fissure 1.87%; total efficiency is 100%. Moreover, it is easy to operate with short treatment, little suffering, little trauma, low expense, no recurence, no infection, no side effect, fine long-term curative effect, making it widely popular with doctors and patients. Observations on Curative Effects of 62 Hemorrhoid Cases Treated by LG 2000 Anorectal Treating Device Lu Chunzhi, Zhang Yuxiang Coloproctology Dept., First Affiliated Hospital to TCM College Abstract: The curative effect of sixty-two hemorrhoid cases treated by LG2000 anorectal treating device (Enhancement) is 100%, averagely reducing 6 days from healing period compared to regular surgery. The patent technology BEIM has been applied to electronic pincers, electronic pencil, and electronic forceps, which makes tissues dry and hard without carbonization, possesses fine orientation performance, assures simultaneous cut and bleeding arresting with great convenience, little suffering, no complications, no trauma, no wound, no recurrence and no infection. Keywords: hemorrhoid; LG2000 anorectal treating device; curative effect observation Our department has treated 62 hemorrhoid cases with satisfactory effect through adopting LG2000 anorectal treating device (Enhancement) manufactured by Zhengzhou Safute Electronic Equipment Co., Ltd. The treatment process is as follows: 1. Data and method All of 112 cases are outpatients, divided into treatment group with 62 and control group with 50. Treatment group: sex-28 males and 34 females; average age-32.5±14.4; course of disease-1 month to 3 years; 40 internal hemorrhoids of Ⅱor Ⅲ grade, 22 Page 5 of 9
  6. 6. thrombotic external hemorrhoids. Control group: sex-21 males and 29 females; average age-33.3±15.5; course of disease-3 months to 4 years; 37 internal hemorrhoids of Ⅱor Ⅲ grade, 13 thrombotic external hemorrhoids. It is not statistically significant in sex and age differences, so cases are comparable(P﹥0.05). 1.1 Treatment method (1) Treatment group: Treated by electronic pincers and electronic pencil of LG 2000 anorectal treating device (E) in dorsosacral or lateral position, sterilized routinely, applied sacral or local anaesthesia, consequently anus becomes completely loose and hemorrhoid nucleus appears entirely. Notice that patients with hypertension, hepatocirrhosis, hemorrhagic diseases, severe heart diseases, psychic diseases, and those in sucking period are excluded. For internal hemorrhoid, use tissue forceps to clip hemorrhoid, uplift it, then adopt electronic pincers to closely clip its base (make sure it is well clipped), step on foot switch for 3-5 seconds, the device sounds alarm and cut electricity automatically when treatment is finished, then remove foot from foot switch, take off pincers, a dry and hard tissue is formed without carbonization. For thrombotic external hemorrhoid, first get rid of skin tissues at the thrombus with electronic pencil, and then treat it with pincers. If hemorrhoid is larger, treat it in the same way for several times with special attention to reserve Skin Bridge. (2) Control group: use traditional ligation for internal hemorrhoid and excision for the external, adopt postoperative anti-infection, and employ sitz bath in PP liquor with concentration of 1:5000 or routine coptis chinensis ointment after defecation. 2. Consequence 2.1 Standard effect Healing: hemorrhoid disappear, no uncomfortable feeling, get better, etc. hemorrhoids dwindle, symptoms lessen Inefficiency: no apparent improvement of symptoms and signs after treatment 2.2 Curative effect See table 1 below: Table1 Curative Effects Constrast between Two Groups in Different Periods 10d 20d 30d Group n n(%) n(%) n(%) Treatment 62 41(66.1) 20(32.2) 1(1.6) Control 50 19(38.0) 26(52.0) 5(10.0) As shown in table 1, most in treatment group are cured for about 10 days, while 20 days for the other. Specially, for treatment group, it takes 13±2.3d to completely finish treatment; control group 19±2.5d, delaying 6d averagely with apparent difference(P﹤ 0.01). 2.3 Untoward reactions 4 cases with anal tenesmus and edema, 1 with anal pain, none with hemorrhage in treatment group; in control group, all with pain and hemorrhage in different degrees, 8 Page 6 of 9
  7. 7. with anal tenesmus, 1 with edema; few untoward reactions and complications, no hemorrhage in former group, but anal edema are comparatively more as contrasted with the latter. 3. Discussion When treating with electronic pincers and pencil of LG2000 anorectal treating device (E), BEIM can intelligently and properly adjust output impedance, water of hemorrhoid tissues vaporizes instantly, the tissues rapidly become dry and hard without carbonization and consequently reach best treatment effect with little bleeding, little suffering, and fine curative effect. It is an ideal anorectal treating device with multiple functions. By adopting an inspection system with a computer and a treating system with electronic pincers, electronic pencil and electronic forceps, LG2000 anorectal treating device (E) can clearly store pictures, compare them before and after treatment, support dynamic replay of treating process, and print color graphic case note with high clarity. Treatment group is superior to control group in healing period and complication, 6d compared with traditional surgery. Besides, there is little suffering, little bleeding during and after surgery, no infection, complications like pain and tenesmus are fewer. While a few patients, with muscle or skin dermatochalasis and circular hemorrhoids, show anal edema in different degrees which can be lessened by hot compress and bed rest. When clipping base of hemorrhoids with electronic pincers, make sure it is well clipped and sealed, excessive inward clip of internal hemorrhoids should be avoided in case intestinal wall is injured, resulting in negative consequences. Acknowledgement: This paper is finished under significant and conducive supervision of Professor Zhang Dongyue and Professor Liu Dianwen, hereby we extend honorable gratitude and appreciation to them. Observations on Curative Effects of 500 Anorectal Disease Cases Treated by LG2000 Anorectal Treating Device Yu Chenghai, Li Peisheng, Zhang Shengli The 460th Hospital of PLA Du Shaoxian The Second Affiliated Hospital to Zhengzhou University Due to the introduction of LG2000 anorectal treating device manufactured by Zhengzhou Safute Electronic Equipment Co., Ltd., curative effects of 100 anorectal disease cases like internal, external and mixed hemorrhoids, anal fissure, hyperthrophy of anal papilla, proctopolypus, anal fistula and perianal abscess are satisfactory from Aug. 2001 to Oct. 2002 . Except for 6 circular hemorrhoid cases who need hospitalization, the rest are all clinical patients with cure rate reaching 98%, no serious complications. Page 7 of 9
  8. 8. 1. Clinical data 500cases in the group, 342 males, 158 females; mini age 9, max 74, average 48.6; 130 internal cases, 70 external, 110 mixed, 70 perianal abscess, 80 anal fistula; all are cured completely one time, except for 10 complicated anal fistular 2. Case selection Diagnostic criteria: refer to criteria made at National Academic Conference on Coloproctology in 1975 3. Treatment method 3.1 Anaesthesia Adopt local prolonged anaesthesia in the perianal, mix 1mm methylthioninium chloride injecta with 10mm lidocaine of 2% and 10mm sodium chloride of 0.9%, stir and dilute them, then start infiltration anaesthesia. 3.2 External hemorrhoid Incise skin of base in the shape of V with high ferquency electronic pencil, clip and cut it off; for patients with several hemorrhoids, skin bridge should be preserved, no twin cut on the same planum in case of anal stenosis after operation. 3.3 Internal hemorrhoid Plan operation according to the number of hemorrhoid and the extent of prolapsus; for a single one, just clip it; for circular ones, clip vertically and horizontally so as to avoid postoperative anal stenosis 3.4 Mixed hemorrhoid For sigle hemorrhoids or those with clear boundary, such as dominant internal hemorrhois with small external ones, clip the internal and external parts toghther; conversly, first use high frequency electronic pencil to incise base in the shape of V, then a little blunt dissection, finally clip and cut off remaining tissues on the two sides respectively. 3.5 Anal fissure For patients with sentinel pile, hypertrophy of anal papilla, subcutaeous fistula, besides routine incision, genucubital position at 9 point and lateral internal sphincter muscle excision are necessary so that spasm of internal sphincter muscle can be eliminated, lessen anal stenosis, anal fissure can be cured within one week. 3.6 Prevention of anal abscess after operation Add Chymotrypsin 1mg to anesthetics, inject it under the incision or spray BFGF-ESSEX locally; Chymotrypsin can break down fibrin, promote calipary and lymphatic circulation; BFGF-ESSEX is used for external application, and is named companion of electronic pencil, hence, effective anal stenosis can be prevented. 4 Evaluation on curative effect 4.1 Standard Healing: 3-6 months after treatment, hemorrhoid disappears when inspected through anoscope, no obvious scar, skin of anal canal and rectal mucous membrane are smooth, no convex or callosity when applied with digital examination, easy and smooth defecation without blood; efficiency: apparent reduced hemorrhoid, no propalapsus, lessened defecation with blood; inefficiency: no better sigh for clinical symptoms. For other anal diseases, healing: focus eliminated, symptoms disappear; Page 8 of 9
  9. 9. apparent efficiency: signs of getting better appear, efficiency: symptoms lessened; inefficiency: no fine sign. 4.2 Consequence For all 500 cases, 490 are healed, cure rate is 98%; 10 cases with inefficiency, taking up 2%. Discussion: 1. LG2000 anorectal treating device treat hemorrhoid via electronic pincers with bipolar coagulation & biological electrical impedance anto-measurement (BEIM) While curing hemorrhoid, high frequency electronic pincers generates heat rapidly to vaporize water of hemorrhoid tissues instantly. The electronical impedance of hemorrhoid tissues becomes larger and larger. While electrical impedance of hemorrhoid tissues matches with output impedance of the device, the tissues become dry and hard without carbonization, and at the same time the device sounds the alarm automatically. Its advantages are: parts are heated regularly, tissues become dry and hard instantly with clear boundary, bleeding is arrested securely and reliably. 2. Easy and convenient operation with multiple functions; wide applicable scope such as internal, external and mixed hemorrhoids, anal fissure, anal fistula, hypertrophy of anal papilla, condyloma acuminata, etc. 3. Short treatment: each hemorrhoid needs only 3-5 seconds; local anesthesia is sufficient, no hospitalization for the most, no affection to normal work and low expense 4. High cure rate, no complications, low recurrence; cure rate for the treated group is 98%; popular among patients All in all, we believe that LG2000 anorectal treating device integrates advantages of electrical ion, RF, microwave and far infrared besides bleeding arresting. It is an ideal device with multiple functions, short treatment period and rare complication. Page 9 of 9