RU2644753C1 - Treatment method of acute and chronic anal crack, complicated by synchronousism - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely, to coloproctology. Performed the introduction of autoplasm, enriched with platelets. In the preoperative period of 20–100 ml of the peripheral blood of the patient, autoplasma is obtained by two-step centrifugation. At the first stage, red blood cells and leukocytes are removed, and on the second stage platelets are concentrated. Then, the isolated fraction is converted to a gel form, adding thrombogenesis activators, after which plasmogel is injected into the inner and outer sphincter of the anal canal at four points corresponding to 1, 5, 7 and 12 hours of the conditioned dial. Next, the anal fissure is excised.

EFFECT: method allows to reduce the pain syndrome in the preoperative and postoperative period, to shorten the healing time of the wound by reducing the spasm and creating favorable conditions for the regeneration of the excised crack, to reduce the frequency of relapses after surgery, and to reduce postoperative complications.

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Description

The invention relates to medicine, namely to coloproctology, and can be used to select the treatment tactics for patients with acute and chronic anal fissures complicated by sphincterospasm.

The problem of diagnosing and treating acute and chronic anal fissures remains a very important and relevant topic in modern coloproctology. In the structure of coloproctologic diseases, the anal fissure takes the third place, second only to hemorrhoids and colitis in prevalence (E. Semionkin, 2004). According to the reversibility data, the incidence of anal fissure is 20-23 cases per 1000 adult population (Vorobev G.I., 2006; Kurdyukova P.G., 2003), and the specific gravity in the structure of colorectal diseases is from 8.5 to 16% ( Vorobiev G.I., 2001, 2006; Zhukov B.N. et al., 1999). Moreover, more than 50% of patients are of working age (Vorobev G.I., 2006; Shelygin Yu.A. et al., 2005; Ortiz H. et al., 2005), which, in addition to medical, also has socio-economic significance (Erel S. et al., 2009).

It is known that one of the causes of the development of a chronic anal fissure is a spasm of the internal sphincter and the pain associated with it (Corman M.L., 2003; Muthukumarassamy R. et al., 2005). J.N. Lund (2006) notes that the pathogenesis of the fissures is not fully understood, but a spasm of the internal anal sphincter is the most constant sign.

Despite the successes achieved in the diagnosis and treatment of acute and chronic anal fissures, the improvement of surgical intervention technologies, including the use of minimally invasive methods of surgical treatment, as well as the constant expansion of the possibilities of medical support, the number of relapses and complications with this pathology over the past decades has remained stably high.

Thus, the high invasiveness of the methods of treatment of anal fissure currently used, leading to long-term rehabilitation and a significant number of complications after surgery, requires the development of new modern low-traumatic methods of treating patients with this pathology.

Studies conducted in patent and scientific medical literature have revealed a significant number of security documents that protect all kinds of treatment methods for acute and chronic anal fissures.

There is a method of complex treatment of anal fissure, consisting in its surgical treatment (excision), which is characterized in that in the preoperative period, a clinical and instrumental examination of the patient is performed to identify the risk of formation of anal incontinence, and with a combination of a number of factors, surgical treatment is limited to excision of the anal fissure and application to the skin of the perianal region of 0.3% nitroglycerin ointment. In this case, sphincterotomy is not performed. The ointment is applied again after 12 hours within 2-8 weeks (RF Patent No. 2216283, class A61B 17/00; publ. November 20, 2003).

A significant drawback of this method is that its use in most cases is accompanied by a number of undesirable side effects, such as tachycardia, headache, dizziness, orthostatic hypotension associated with the use of nitrates. This leads to the fact that most patients cannot be given a full course of treatment due to the emerging need for periodic interruption. The recurrence rate of the disease using this method, according to the author, was quite high and reached 50%.

There is a method of complex treatment of chronic anal fissure, including excision of the anal fissure, characterized in that sphincteromanometry is performed before surgery. At basal pressure in the anal canal in the projection of the internal sphincter from 60 to 120 cm of the water column, the sphincters are dissected longitudinally in the area from 3 to 5 hours of the nominal dial, and at a basal pressure in excess of 120 cm of the water column, the sphincters are additionally dissected longitudinally in the area from 9 to 7, 5 hours (RF Patent No. 2293529, class A61B 17/00; publ. 02.20.2007).

The disadvantages of this method of treatment include the risk of complications in the form of postoperative stenosis of the anal canal or incontinence of varying severity. There is also a risk of wound infection after sphincterotomy with the subsequent development of paraproctitis and fistulous passages. In the presence of running concomitant pathology of the anal canal (hemorrhoids, polyps, etc.), the method becomes technically difficult to implement.

A known method for determining the treatment of anal fissure, characterized in that the first is determined by a point index by summing up special evaluation points. At a point index of 8 to 11 points, indications are given for excision of a crack without sphincterotomy, and at a point index of more than 11 points, indications for excision of a crack in combination with dosed sphincterotomy are established (RF Patent No. 2310371, CL A61B 5/00; publ. 20.11. 2007).

The disadvantage of this method is the difficulty in determining the point index, the possibility of errors in the calculations, and the need to use a large amount of additional complex equipment for this purpose.

A known method of surgical treatment of chronic anal fissure, including the use of botulinum toxin A at a dose of 20-35 U, which is injected at 4 points into the internal anal sphincter for 1, 5, 7 and 11 hours, respectively, with simultaneous subcutaneous injection of 5-7 U of botulinum toxin under the crack its distal edge. In addition, a conditioned medium of mesenchymal stem cells is introduced into the rectum at a dose of 20-30 ml (RF Patent No. 2537230, class A61K 5/12; publ. 11/20/2013).

The disadvantages of this method include the high cost of the ingredients used and the need for repeated administration of botulinum toxin after a certain time interval (2-3 months). The limitations of the use of this method can also include the possibility of an allergic reaction to botulinum toxin in patients and the difficulty of obtaining a conditioned environment of mesenchymal stem cells.

The prototype of the present invention, the closest in combination of features to the claimed method, is a method for the treatment of acute anal fissure, characterized in that autoplasma in a volume of 2-2.5 ml is injected under the fissure. Previously, autoplasma is bubbled for 5 minutes with an ozone-oxygen mixture (RF Patent No. 2578853, class A61B 17/00; publ. 04/13/2015).

The disadvantages of this method of treatment include the need to use for this purpose a large amount of additional complex equipment for bubbling autoplasma with an ozone-oxygen mixture, and the complexity of this process should also be noted. In addition, the introduction of the resulting solution only under the crack does not solve the issue of sphincterospasm, which in the present invention stops after the introduction of platelet-rich plasma at several points around the circumference of the anal canal. This avoids sphincterotomy and reduces the likelihood of a relapse of the disease by eliminating the pathogenetic factor: spasm of the sphincter of the anal canal.

The aim of the present invention is to reduce the morbidity of surgical intervention and, accordingly, to reduce postoperative pain in patients with anal fissure, which leads to a reduction in the length of stay of patients in the hospital and thus helps to increase the effectiveness of treatment.

The objective of the invention is to develop a new effective treatment for acute and chronic anal fissures complicated by sphincterospasm. The disadvantages of the prototype are eliminated in the claimed invention.

The claimed method of treating acute and chronic anal fissures helps to reduce pain in the preoperative and postoperative stages, reduces the time of treatment of patients in the hospital, helps to avoid complications characteristic of sphincterotomy (anal sphincter insufficiency or postoperative stricture) and reduces the likelihood of disease recurrence by eliminating the pathogenetic factor ( spasm of the sphincter of the anal canal).

The problem is solved by the fact that before the operation (excision of the anal fissure), the sphincter tone is examined on the basis of objective physical and instrumental (sphincterometry) studies. In the course of the study, patients who have an increased tone of the rectal sphincter are treated with PRP therapy (Platelet Rich Plasma or platelet-rich plasma therapy) in the preoperative period. Then they carry out surgical treatment - excision of the anal fissure.

The technical result of the claimed invention is: reduction of pain in the preoperative and postoperative period, reduction of wound healing time by reducing spasm and creating favorable conditions for the regeneration of excised fissures, reducing the frequency of relapses after surgery, as well as reducing postoperative complications.

The technical result is achieved in that a method of treating an acute and chronic anal fissure complicated by sphincterospasm involves the introduction of autoplasma enriched in platelets. In accordance with the invention, in the preoperative period, autoplasma is obtained from 20-100 ml of the patient’s peripheral blood by two-stage centrifugation, while the first stage removes red blood cells and white blood cells, and the second concentrates platelets. Then the selected fraction is transferred into a gel form, adding thrombotic activators. After this, the plasmogel is injected into the internal and external sphincter of the anal canal at four points corresponding to 1, 5, 7 and 12 hours of the conditional dial. Then carry out the excision of the anal fissure.

At present, no one doubts the effect of spasm of the sphincter of the anal canal on the course of the disease: the intensity of the pain syndrome, the frequency of relapse, the duration of wound healing, etc. However, other factors, such as stool disturbance (diarrhea or constipation), anatomical features of the anal canal (congenital or acquired stenosis of the anal canal), also affecting the course of the disease. Most often, it is the combination of all the above factors that creates the most favorable background for the onset of the disease and the development of its relapses, however, it is the spasm of the anal canal that is crucial for the course of an acute or chronic anal fissure.

The method of treatment of acute and chronic anal fissures developed and tested by us is pathogenetically substantiated. On the basis of experimental and clinical studies, the need for correction of the spasm of the sphincter of the anal canal is proved both at the preoperative stage of treatment and after surgical excision of the anal fissure. Otherwise, there is a likelihood of the formation of the so-called "vicious circle." We have proved that it is the spasm of the sphincter of the anal canal that contributes to the formation and subsequent recurrence of the anal fissure, which is confirmed by our clinical observations. The elimination of this factor breaks the pathological "vicious circle", is accompanied by a significant decrease in the tone of the rectum sphincter and a reduction in the healing time of the postoperative wound, which leads to a decrease in the frequency of postoperative relapse of the disease.

We have proved the relationship between the duration of sphincterospasm and the condition of the anal fissure. If the spasm persists for less than a month, then the crack is acute and heals on its own against the background of conservative therapy, if sphincterospasm exceeds 1 month, then the crack passes from acute to chronic and there is a need for its surgical treatment.

Our studies have proved a direct correlation between the severity of sphincterospasm and the intensity of the pain syndrome. So, with an increase in sphincter spasm, which is recorded using sphincterometry, there is a clear increase in pain.

A detailed description of the method and examples of its clinical implementation.

At the preoperative stage, in patients with an acute or chronic anal fissure, an anamnesis is collected, an objective physical and instrumental examination (anoscopy, sigmoidoscopy, sphincterometry) is performed. In order to objectively assess the condition of the external and internal sphincter of the rectum, sphincterometry is performed. Used sphincterometer S4401 (Germany). In the process of examining patients, establishing a diagnosis of the disease and identifying concomitant pathology, a close relationship was proved clinically and instrumentally between the spasm of the sphincter of the anal canal (functional stenosis of the anal canal) and the presence of acute or chronic anal fissure.

In the preoperative period, the following medical procedures were used. Previously, to obtain Platelet Rich Plasma or platelet-rich plasma, 20-100 ml of peripheral blood is taken from the patient. Using two-stage centrifugation, first red blood cells, as the heaviest shaped elements, and white blood cells (platelets remain in the supernatant) are removed from whole blood, and then, during the second centrifugation, platelets are concentrated. To increase usability, thrombus activators (thrombin + calcium chloride) are added to the isolated fraction. The resulting gel is used independently. The whole process takes 20-30 minutes and allows you to get Platelet Rich Plasma or platelet-rich plasma with a platelet concentration of 3-5 times higher than in peripheral blood.

Then, in the patient’s position on the left side (in the embryo position), after preliminary treatment of the surgical field with a disinfectant solution at 1, 5, 7, and 12 hours, an autologous enriched platelet plasma was injected with a syringe into the internal and external sphincter using a conditional dial. A good therapeutic effect was achieved due to the high concentration of platelets in the injected autoplasma. Normally, the platelet concentration in the blood varies between 150 thousand / μl and 350 thousand / μl and averages 200 thousand / μl. It has been scientifically proven that the stimulating effect of platelet-rich plasma is manifested if the platelet concentration in it is 1,000,000 / μl. Therefore, at the moment the plasma is called rich in platelets, if their concentration in it is equal to 1,000,000 / μl. With conventional medication, the healing of such cracks is very slow, since these areas are poorly supplied with blood. In acute and chronic anal fissures, enriched plasma is injected directly into the sphincter, which contributes to rapid tissue remodulation.

Platelets produce numerous active substances - growth factors, including: fibroblast growth factor, transforming, epidermal, vascular endothelial, etc. Growth factors attract stem cells and trigger restoration processes - cell division, collagen and elastin synthesis, tissue repair, angioneogenesis.

The criteria for the effectiveness of treatment are the elimination or decrease in the intensity of the pain syndrome due to relaxation of the sphincter of the anal canal, the reduction of the patient’s hospital stay, high physical activity and patient capacity in the early postoperative period, the absence of complications in the early and late postoperative periods, as well as an excellent subjective assessment of their overall state by the patient. Proof of a good treatment result will be sphincterometry, performed after 1 and 6 months of the operation field and indicating normal pressure in the anal canal, as well as the absence of any complaints from the patient.

The need to use the proposed method is confirmed by the following clinical examples.

Clinical example 1

Patient P-in, 37 years old, was hospitalized in the department of coloproctology 02/26/2016, with complaints of pain in the anus after the act of defecation, poor bleeding, constipation. From the anamnesis it is known that it is sick for about 4 months, the disease was preceded by constipation, had previously been treated repeatedly by a gastroenterologist in a community clinic. Upon admission, the patient's condition is moderate, the skin is pale pink in color. There is hard breathing in the lungs on both sides, no wheezing. The respiratory rate is 19 per minute. Blood pressure - 120/80 mm Hg, heart rate - 70 per minute. The tongue is wet, coated with a white coating. On palpation, the abdomen is soft, painless in all departments. In a local study, the anal region without pathological changes, at 6 o’clock of the conditional dial in the supine position, the anal fissure is 1.5 × 0.5 × 0.2 cm in size, with Cicatrical edges and a “guard tubercle”. Rectal examination is painful, sphincter tone is increased. Sphincterometry indices: average resting pressure 68 mmHg, average value with strong-willed contraction - 130 mmHg

In the preoperative period of February 28, 2016, the patient was injected with autologous enriched platelet plasma into the internal and external sphincter of the anal canal at 1, 5, 7 and 12 hours according to the conditional dial. 02/30/2016, surgical treatment was performed in the amount of excision of a chronic anal fissure with the Surgitron apparatus. The postoperative period was uneventful with a moderate pain syndrome; with a digital examination of the rectum, before the patient was discharged from the hospital, a subjective decrease in the tone of the rectal sphincter was noted in comparison with the initial data. The patient was discharged from the "day hospital" on the 10th day. A wound with signs of epithelization, the bowel movement is moderately painful. During the control examination 1 month after the operation, hypertonicity of the rectal sphincter was not revealed (sphincterometry data: average resting pressure - 54 mm Hg, average value for voluntary contraction - 114 mm Hg). No data were found for the recurrence of the disease, no other anorectal pathology was found, the patient is able to work. The patient rated his health on a scale of general clinical impression as "a big improvement." 6 months after discharge during the follow-up examination, data for relapse were not revealed.

Example 2

Patient T-ko, 34 years old, was admitted to the coloproctology department with complaints of pain in the anal canal during and after the act of defecation, poor allocation of blood from the rectum. From the anamnesis it is known that it is sick for about 5 months. The disease was preceded by a mechanical injury during intercourse. The outpatient treatment previously conducted to the patient had no effect. Upon admission, the patient's condition is moderate. The skin is pale pink in color. In the lungs, vesicular breathing on both sides. Respiratory rate - 16 per minute. Blood pressure - 110/70 mm Hg, heart rate - 72 per minute. The tongue is wet. On palpation, the abdomen is painless. An objective examination of the patient in the supine position at 6 and 12 o’clock of the conditional dial in the anal canal identifies two anal fissures with dimensions of 1.6 × 1.2 × 0.3 cm with cicatricial edges. Rectal examination is sharply painful, the sphincter tone is subjectively increased. Indices of intraanal pressure, according to sphincterometry: the average resting pressure is 69 mm Hg, the average value for volitional contraction is 139 mm Hg.

In the preoperative period 03.02.2016, the patient was injected with autologous enriched platelet plasma into the internal and external sphincter of the anal canal at 1, 5, 7 and 12 hours according to the conditional dial. 02/05/2016, surgical treatment was performed - excision of chronic anal fissures with the Surgitron apparatus.

The postoperative period was uneventful, without complications, with a mild pain syndrome. A digital examination of the rectum showed a subjective significant decrease in the tone of the sphincter of the rectum compared with the initial data. The patient was discharged from the "day hospital" on the 14th day after the operation. A postoperative wound with signs of epithelization, the bowel movement is moderately painful, there is no bleeding from the rectum. During the follow-up examination after 1 month according to sphincterometry: the average resting pressure is 60 mm Hg, the average value for volitional contraction is 120 mm Hg, no data were found for the recurrence of the disease, no other anorectal pathology was found, and the disability was restored. The patient rated his health on a scale of general clinical impression as "a very big improvement." 6 months after discharge during the follow-up examination, data for relapse were not revealed.

The method was tested on the clinical base of the Department of General Surgery of the Rostov State Medical University in 50 patients with anal fissures, which made up the main group of patients. The control group consisted of 60 patients who underwent traditional surgical treatment without the use of PRP therapy. Results: absence of recurrence of the disease after surgery in the main group of patients (in the control group, 12 patients had a recurrence of anal fissure), halving the healing time of the postoperative wound in patients of the main group compared with the control group of patients. In patients of the control group, disability is restored on the 2nd-3rd day after the operation (on average, 2.1 ± 0.4 days), while in the control group of patients this indicator ranged from 5 to 14 days (on average - 9.4 ± 1.8 days). Moreover, the subjective assessment of their well-being by patients of the main group in the early and late postoperative periods was interpreted as “good” and “very good”.

Thus, the identification of violations of the sphincter tone in patients with chronic anal fissures and their adequate correction can significantly improve the results of surgical treatment of this category of patients and reduce the healing time of postoperative wounds.

An analysis of the results showed that the application of the pathogenetically substantiated method of complex treatment of chronic and acute anal fissures that we proposed can significantly reduce the number of complications and relapses of the disease (almost completely eliminate them), which undoubtedly helps to increase the effectiveness of treatment.

The proposed method has the following advantages. The application of the proposed method improves the treatment of patients with chronic and acute anal fissures. Its use allows to improve the treatment results of patients with acute or chronic anal fissures due to a significant reduction in the number of complications and relapses of the disease in the early and late postoperative periods due to the provision of stable relaxation of the sphincter of the anal canal and a decrease in the intensity of the pain syndrome. This is also confirmed by a decrease in the length of hospital stay of patients, their high ability to work in the early postoperative period and an excellent subjective assessment of their general condition by the patients themselves.

The inventive method of treating patients with acute and chronic anal fissures was tested on sufficient clinical material, showed the effectiveness of the application and can be recommended for use in specialized coloproctological hospitals.

Claims (1)

A method of treating acute and chronic anal fissure complicated by sphincterospasm, including the introduction of autoplasma enriched with platelets, characterized in that in the preoperative period from 20-100 ml of the patient’s peripheral blood receive autoplasma by two-stage centrifugation, while the red blood cells and leukocytes are removed at the first stage, and on the second - platelets are concentrated, then the isolated fraction is converted into a gel form, adding thrombus formation activators, after which the plasmogel is introduced into the internal and external sphinx ep anal canal four points corresponding to 1, 5, 7, and 12 o'clock of the dial conditional then carried excision anal fissure.