RU2639039C1 - Method for anal fissure treatment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: for treatment of a chronic anal fissure, it is excised along with the surrounding scar tissue and the guard tubercle by two half-moon incisions within healthy tissues. 0.1-0.2 ml doses of autoplasma, enriched with platelet growth factors, is injected into the wound walls and bottom with a grid of 3-4 mm. Wound edges are separated by a rectal mirror. A film of enriched autoplasm is applied to the wound bottom. Enriched autoplasm in a volume of 1 ml is injected under the wound, to a depth of 5-7 mm. Botulinum toxin A at a dose of 15-20 units is injected into the inner sphincter at three points to a depth of 5-7 mm. In case of back fissure, botulinum toxin is administered at 5, 7 and 12 hours, in case of front fissure - at 11, 1 and 6 hours. On the 4th day, the introduction of autoplasm is repeated.

EFFECT: reduces postoperative pain syndrome, increases the effectiveness of anal fissure treatment, reducing the risk of postoperative complications.

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Description

The invention relates to medicine, namely to coloproctology, and can be used in the treatment of anal fissure.

Anal fissure takes third place in the structure of diseases of the colon, which is 5.3-11.7%. More often women (over 60%) suffer and more than a third of patients are of working age. An anal fissure occurs due to damage to the mucosa of the anal canal, usually with constipation or diarrhea. In 70% of cases, a combination of anal fissure with hemorrhoids is noted. In 85% or more cases, the fissure is located along the posterior circumference of the anal canal at 6 o’clock on the conditional dial and in 8-9%, mainly in women, along the front wall at 12 o’clock and rarely (about 0.5%) on the side walls of the anal canal. In 3-4%, a combination of two cracks along the posterior and anterior walls of the anal canal is found. (Fedorov V.D., Dultsev Yu.V. Proctology - Medicine 1984 - 384 p.).

Known surgical and non-surgical methods for the treatment of chronic anal fissure.

A known method of treating anal fissure with the introduction of botulinum toxin (RF patent No. 2537230, publ. 12/27/2014). The essence of this method is the introduction of botulinum toxin A at a dose of 20-35 U at 4 points into the internal sphincter of the anal canal for 1, 5, 7 and 11 hours with the simultaneous subcutaneous injection of 5-7 U of botulinum toxin under the distal edge of the fissure and the conditional introduction into the rectum environment of mesenchymal stem cells in a dose of 20-30 ml.

The disadvantages of this method include the impossibility of treating cracks in this way with pronounced cicatricial changes and in the presence of “sentinel” tubercles, anal polyps.

There is also a method of treating anal fissure and long non-healing wounds of the anal canal (RF patent No. 2578853, publ. 03/27/2016). The essence of the method is that autoplasma taken from a patient after sparging with an ozone-oxygen mixture for 5 minutes and converting it into a gel form by heating is injected under an anal fissure in the amount of 2.5-3.0 ml. This method allows to improve the epithelization of wounds and postoperative rehabilitation of patients.

The disadvantages of the method include the introduction of the obtained gel in one portion into the wound, which leads to an uneven acceleration of reparative processes due to the different distribution of platelet-rich autoplasma in the volume of tissues.

This method was not used to treat postoperative anal canal wounds.

The most common is the method of surgical treatment of an anal fissure under local or general anesthesia: after a rectal speculum is inserted into the rectum, the fissure is excised with two semilunar incisions within healthy tissues along with a watchdog tubercle, while the bottom of the wound is the internal anal sphincter. Then a metered sphincterotomy is performed along the posterior or lateral circumference of the anal canal to a depth of 4-6 mm in women and up to 8 mm in men. Conduct hemostasis, while the wound is not sutured. The anal canal is swabbed with a gauze cloth with ointment. The healing time of the postoperative wound is 44.22 ± 2.35 days, and the intensity of the pain on the first day after surgery is 6.0 ± 1.3 cm on a visual-analogue scale. (Shelygin Yu.A., Frolov S.A., Orlova L.P., Podmarenkova L.F., Poletov N.N., Zharkov E.E., Dzhanaev Yu.A. Direct results of complex treatment of chronic anal fissure. // Coloproctology No. 1 (31) 2010).

However, when using this method, there is the possibility of the formation of abscesses and hematomas in the area of sphincterotomy in the early postoperative period. The formation of fistulas of the rectum is noted in 0.2-1.6% in the long-term postoperative period. In 0.6-19.6% of patients, the weakness of the anus sphincter persists, of which I degree of incontinence is observed in 0.6-11.6%, II degree - in 6-8% of cases. Relapse of the disease was noted in 0.6-11.1%) patients (Shelygin Yu.A., Zharkov E.E., Orlova L.P., Podmarenkova L.F. Long-term results of excision of the anal fissure in combination with lateral subcutaneous sphincterotomy. // Actual problems of coloproctology. M., 2005. - pp. 141-142; Shelygin Yu.A., Zharkov E.E., Orlova L.P., Podmarenkova L.F.) Risk of anal incontinence after excision of the anal fissure in combined with lateral subcutaneous sphincterotomy. // Actual problems of coloproctology. - 2005. - No. 1 (11). - from. 10-16.

The problem solved by the invention is to increase the effectiveness of the treatment of anal fissure while reducing the likelihood of developing postoperative complications and reducing postoperative pain.

The technical result consists in preventing the development of such postoperative complications as anal incontinence, the development of abscesses and hematomas, and the formation of fistulas.

The problem is solved by a method of treating a chronic anal fissure, including excising it together with the surrounding scar tissue and the guard tubercle with two semilunar incisions within healthy tissues, characterized in that autoplasma enriched with platelet-derived growth factors (TGF) is introduced into the walls and bottom of the wound with a mesh in increments of 3 -4 mm in 0.1 ml, then, diluting with a rectal mirror the edges of the wound, a film of TGF-enriched autoplasma is applied to its bottom, and 1-ml TGF-enriched autoplasma is introduced under the wound in a volume of 1 ml to a depth of 5-7 mm, the following stage injected botulinum toxin A in a dose of 15-20 Units into the internal sphincter at three points to a depth of 5-7 mm, with a back crack at 5, 7 and 12 hours, with a front crack at 11, 1 and 6 hours, on the 4th day the procedure for introducing enriched TGF autoplasma is repeated.

The method is as follows.

In patients, 30 minutes before surgery, blood is taken in 4 sterile tubes with a volume of 9 ml with an anticoagulant component. After blood sampling, the tube is turned over several times to mix the blood and anticoagulant. Next, the blood is centrifuged for 8 minutes at a speed of 6500 rpm. In sterile conditions, autoplasma enriched with platelets is selected. First remove the top platelet plasma with a low platelet count. A platelet rich layer is then taken. A 10% calcium chloride solution is added to the resulting platelet-rich autoplasma at the rate of 50 μl of calcium chloride per ml of enriched plasma in order to destroy platelets and release TGF. About 9 ml of TGF-enriched autoplasma are obtained from the starting material, 4 ml of which are used to produce the film. The resulting plasma in a volume of 4 ml is placed in a sterile glass bowl with a lid. The bowl is placed in a thermostat for 20 minutes: first with a temperature of 37 ± 1 ° C to form a fibrin membrane, then at a temperature of 50 ° C the film is finally formed. The remaining 5 ml of TGF-enriched autoplasma is used for injection into the bottom and walls of the postoperative wound.

Surgical intervention is performed with excision of the anal fissure with two semilunar incisions within healthy tissues, then an TGF-enriched autoplasma is injected into the walls and bottom of the wound with a mesh of 3-4 mm increments of 0.1-0.2 ml using an insulin syringe, then diluting the edges of the wound with A rectal mirror is placed on its bottom with a film of enriched TGF autoplasma, after which a 1 ml enriched TGF autoplasma is injected under a postoperative wound to a depth of 5-7 mm. The next stage is the introduction of botulinum toxin A at a dose of 15-20 U into the internal sphincter at three points to a depth of 5-7 mm: with a back crack for 5, 7 and 12 hours, with a front one for 11, 1 and 6 hours. On the 4th day after the operation, an autoplasma enriched with TGF is re-injected into the edges and bottom of the wound with a mesh in increments of 3-4 mm in 0.1-0.2 ml increments, then, spreading the edges of the wound with the fingers, a film of enriched TGF autoplasma, and under the wound injected enriched TGF autoplasma in a volume of 1 ml to a depth of 5-7 mm.

We present clinical examples of the method.

Example 1

Patient K., 31 years old, was admitted with complaints of pain during and after defecation, scarlet blood discharge in the feces. During anoscopy: at 6 o’clock on the conditional dial, an anal fissure with dimensions of 1.5 × 0.5 × 0.5 cm with altered, tight edges was revealed, the sphincter tone was sharply increased - sphincterospasm.

30 minutes before the operation, blood was taken in 4 sterile tubes with a volume of 9 ml with an anticoagulant component. After blood sampling, the tube was turned over several times to mix the blood and anticoagulant. Further, the blood was centrifuged for 8 minutes at a speed of 6500 rpm. Under sterile conditions, autoplasma enriched with platelets was selected. First, the upper platelet-rich plasma was removed. Then a platelet rich layer was taken. A 10% calcium chloride solution was added to the obtained platelet-rich autoplasma at the rate of 50 μl of calcium chloride per 1 ml of enriched plasma in order to destroy platelets and release TGF. About 9 ml of TGF-enriched autoplasma were obtained from the starting material, of which 4 ml was used to obtain the film. The resulting plasma in a volume of 4 ml was placed in a sterile glass bowl with a lid. The bowl was placed in a thermostat for 20 minutes: first, with a temperature of 37 ± 1 ° C to form a fibrin membrane, then at a temperature of 50 ° C the film was finally formed. The remaining 5 ml of TGF-enriched autoplasma was used for injection into the bottom and walls of the postoperative wound.

Then, surgery was performed with excision of the anal fissure with two semilunar incisions within healthy tissues, after which an autoplasma enriched with TGF was introduced into the walls and bottom of the wound with a mesh in 3 mm steps of 0.1 ml, then, after diluting the edges of the wound, a film was placed on its bottom from TGF-enriched autoplasma, TGF-enriched autoplasma was administered under the wound in a volume of 1 ml to a depth of 7 mm, botulinum toxin A at a dose of 15 Units was introduced into the internal sphincter at three points to a depth of 5 mm at 5, 7 and 12 hours as the next step.

On the 4th day after the operation, a second injection of TGF-enriched autoplasma is repeated into the edges and bottom of the wound with a mesh in 3 mm increments of 0.1 ml, then, spreading the wound edges with the fingers, a film of TGF-enriched autoplasma is placed on the bottom of the wound, and under the wound TGF-enriched autoplasma is introduced in a volume of 1 ml to a depth of 7 mm. On the 4th day, the procedure was performed without the introduction of botulinum toxin A.

The wound healed by secondary intention on the 26th day. At the follow-up examination after 2 months, the patient does not complain, the sphincter tone is normal, and examination of the mucosal defects was not determined.

Example 2

Patient S., 24 years old, was admitted with complaints of severe pain during and after defecation. An objective examination: at 12 o’clock on the conditional dial, a crack of 1.0 × 0.5 × 0.2 cm in size with scar-changed dense edges, a guard polyp of 0.5 × 0.3 × 0.2 cm was identified, and a sphincter spasm was noted.

30 minutes before the operation, blood was taken in 4 sterile tubes with a volume of 9 ml with an anticoagulant component. After blood sampling, the tube was turned over several times to mix the blood and anticoagulant. Further, the blood was centrifuged for 8 minutes at a speed of 6500 rpm. Under sterile conditions, autoplasma enriched with platelets was selected. First, the upper platelet-rich plasma was removed. Then a platelet rich layer was taken. A 10% calcium chloride solution was added to the obtained platelet-rich autoplasma at the rate of 50 μl of calcium chloride per 1 ml of enriched plasma in order to destroy platelets and release TGF. About 9 ml of TGF-enriched autoplasma were obtained from the starting material, of which 4 ml was used to obtain the film. The resulting plasma in a volume of 4 ml was placed in a sterile glass bowl with a lid. The bowl was placed in a thermostat for 20 minutes: first, with a temperature of 37 ± 1 ° C to form a fibrin membrane, then at a temperature of 50 ° C the film was finally formed. The remaining 5 ml of TGF-enriched autoplasma was used for injection into the bottom and walls of the postoperative wound.

Surgery was performed with excision of the anal fissure with two semilunar incisions within healthy tissues, after which the autoplasma enriched with TGF was introduced into the walls and bottom of the wound with a mesh with a step of 4 mm, 0.2 ml each, then a film of enriched TGF was placed on the bottom of the wound. autoplasma, then TGF-enriched autoplasma was administered under the postoperative wound in a volume of 1 ml to a depth of 5 mm, the next stage was injected botulinum toxin A at a dose of 20 units into the internal sphincter at three points at a depth of 7 mm at 11, 1 and 6 hours.

On the 4th day after the operation, a second injection of TGF-enriched autoplasma is repeated into the edges and bottom of the wound with a mesh of 4 mm increments of 0.2 ml, then, spreading the wound edges with the fingers, a film of TGF-enriched autoplasma is placed on the bottom of the wound, and under the wound TGF-enriched autoplasma is introduced in a volume of 1 ml to a depth of 5 mm. On the 4th day, the procedure was performed without the introduction of botulinum toxin A. The wound healed by secondary intention on the 28th day. During the follow-up examination after 3 months, the patient does not complain, the sphincter tone is normal, with a manual examination of the mucosal defects were not determined.

On the basis of our clinic, the described method has been successfully applied in 15 patients. Each patient underwent 2 procedures on the 1st and 4th days of the postoperative period. In the postoperative period, patients were assessed for the intensity of the pain syndrome using a visual analogue scale. The intensity of the pain syndrome in the first day after the operation was 4.1 ± 1.5 cm, the healing time of the postoperative wound was 31.15 ± 3.54 days. There was a decrease in pain by an average of 30%, starting from the first day after surgery, compared with the control group of patients. The healing time of the postoperative wound was 31.15 ± 3.54 days, which is 25% faster than in patients who did not use TGF and botulinum toxin A.

The combined action of botulinum toxin A and TGF-enriched autoplasma has a synergistic effect: due to the action of botulinum toxin, muscle spasm is reduced, microcirculation improves, which leads to a better distribution of TGF-enriched autoplasma in tissues and accelerates its action.

Thus, the method according to the invention increases the effectiveness of the treatment of anal fissure while reducing the likelihood of developing postoperative complications and reducing postoperative pain.

Failure to conduct a sphincterotomy leads to a decrease in surgical trauma and a decrease in the likelihood of developing postoperative complications such as anal incontinence, the development of abscesses and hematomas, and the formation of fistulas.

Claims (1)

A method for treating a chronic anal fissure, including excising it together with the surrounding scar tissue and the guard tubercle with two lunate incisions within healthy tissues, characterized in that they introduce an autoplasma enriched with platelet growth factors into the walls and bottom of the wound with a mesh with a step of 3-4 mm by 0 , 1-0.2 ml, then, diluting with a rectal mirror the edges of the wound, a film of autoplasma enriched with platelet growth factors is applied to its bottom, and autoplasma enriched with platelet growth factors is introduced into the w 1 ml to a depth of 5-7 mm, the next step is to inject botulinum toxin A at a dose of 15-20 U into the internal sphincter at three points to a depth of 5-7 mm, with a back crack for 5, 7 and 12 hours, with a front one for 11 , 1 and 6 hours, on the 4th day, the procedure for introducing platelet-rich autoplasma is repeated.