RU2386441C1 - Method for prevention of adhesive process in peritoneal cavity in obstetric-gynaecologic surgeries - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to obstetrics and gynaecology. The method for prevention of adhesive process in peritoneal cavity in obstetric-gynaecologic surgeries involving administration of chitosan compounds and differing that the compound is applied in layer-by-layer suturing of an operative wound in preperitoneal and skin structure of anterior abdominal wall. The compound represents a sponge measured 60×100×4 mm to 240×180×4 mm and containing 2% collagen acetate, 2% chitosan ascorbate of degree of deacetylation 95% and more, molecular weight 100 to 700 kDa, ascorbic acid - 1.8 g/g of dry chitosan, chondroitin-sulphuric acid - 5-100 mg/g of dry chitosan, hyaluronic acid - 10-100 mg/g of dry chitosan, heparin - 2.5-5 mg/g of dry chitosan and bovine serum growth factor "Adgelon" - 11-220 mkg/g of dry chitosan.

EFFECT: method improves effectiveness of prevention of postoperative adhesive process in small pelvis in women, prevents development of exudative processes in the operative wound tissues and accelerates the healing.

2 tbl, 1 ex

Description

The invention relates to medicine, namely to obstetrics and gynecology, and can be used to prevent adhesions in the peritoneal cavity during obstetric and gynecological operations.

There are various methods for the prevention of adhesions, which differ in the mechanism of action, method of application and effectiveness. This includes corticosteroid hormones (hydrocortisone), drugs that act on blood coagulation (clexane), and means for creating artificial ascites (isotonic sodium chloride solution, dextran) [1, 4]. In order to reduce the degree of adhesion, anti-adhesive substances are used in the form of an adhesive active hydrogel based on cross-linked polyacrylamide with a dynamic viscosity of at least 1.0 [2], Elton irrigating agent [3], in the form of ingredients such as aqueous cellulose gel applied on the parietal or visceral sheets of the peritoneum [5], carry out laser and ozone therapy [6-8].

However, existing methods of prevention are often ineffective, as a rule, highly invasive, suggest the introduction of foreign ingredients into the serous cavities, can increase the risk of infection in the peritoneal cavity, cause an inflammatory process, and additionally provoke the formation of adhesions and fibrosis. Many drugs used for this purpose are ineffective in the presence of liquid and cellular components of the blood. Not all methods are easy to use and affordable due to their high cost.

There is a method consisting in conducting ultrasound therapy in the field of surgical intervention in a pulsed manner using low-frequency pulses with a pulse duration of 10 m / s, the intensity of the generated pulse 0.7 W / cm ² labile technique 1 time per day for 10 minutes in quantity 7 procedures [1]. However, despite the fact that this method is non-invasive, the treatment is not effective enough, there is a low ability to reduce the formed adhesive process in the small pelvis, conditions for inflammatory processes in the tissues of the postoperative wound are formed.

Known methods for treating the adhesion process in the pelvis in women after gynecological operations on the uterus and its appendages, which include either ultrasound therapy to the area of the appendages in a pulsed mode using low-frequency pulses, before which ascorbate-based gel is applied to the skin in the area of hypogastrium chitosan containing metronidazole [8], or a chitosan gel with metronidazole on a swab without physiotherapy sessions is independently injected into the vagina [9] or into the cavity of the rectum [10] or by gavage into the gastric cavity [11]. However, these methods are intended to treat an existing adhesive process in the pelvis, and not to prevent this postoperative complication. In addition, the application of the therapeutic composition in these methods is carried out within the mucous membranes or skin, which significantly reduces the effectiveness of the therapeutic or prophylactic effect on the adhesion process in the peritoneal cavity due to the multilayer barriers between the peritoneal integument and the therapeutic composition.

The objective of the invention is to increase the effectiveness of prevention of the formation of adhesions in the pelvis in women in the postoperative period, preventing the development of exudative processes in the tissues of the postoperative wound and accelerating the healing time.

The objective is achieved due to the fact that the composition based on chitosan is applied by layer-by-layer suturing of the surgical wound into the preperitoneal and subcutaneous tissue of the anterior abdominal wall, the composition being a sponge from 60 × 100 × 4 mm to 240 × 180 × 4 mm in size, which contains 2% collagen acetate, 2% chitosan ascorbate with a deacetylation degree of more than 95%, molecular weight from 100 to 700 kDa, ascorbic acid - 1.8 g / g dry chitosan, chondroitin acid - 5-100 mg / g dry chitosan, hyaluronic acid - 10-100 mg / g of dry chitosan, heparin - 2.5-5 mg / g of dry chitosan and serum cattle growth factor "gelon" - 11-220 μg / g of dry chitosan.

The method is as follows. Perform a collar-shaped suprapubic operative access through the anterior abdominal wall. A cesarean section is performed in the lower uterine segment according to one of the methods adopted in obstetrics, after removing the fetus, the uterine wall, cystic-uterine fold are closed, then hemostasis and revision of the abdominal cavity are checked. After suturing the parietal sheet of the peritoneum, a sponge containing 2% collagen acetate, 2% chitosan ascorbate with a deacetylation degree of more than 95%, molecular weight from 100 to 700 kDa, ascorbic acid - 1.8 g / g dry chitosan, chondroitersulfuric acid is introduced into the preperitoneal tissue - 5-100 mg / g of dry chitosan, hyaluronic acid - 10-100 mg / g of dry chitosan, heparin - 2.5-5 mg / g of dry chitosan and serum growth factor of cattle "gelon" - 11-220 μg / g of dry chitosan, ranging in size from 60 × 100 × 4 mm to 240 × 180 × 4 mm. Next, the muscle layers and aponeuroses of the anterior abdominal wall are stitched in layers. Before closing the subcutaneous fat layer between it and the fascial-muscular layer, the same sponge is inserted and the subcutaneous fat and skin are sutured tightly with separate nodular nylon sutures. The postoperative period is 7-10 days, after 1 month, a follow-up examination of women is carried out in the conditions of the patronage of the women's consultation.

Prevention of the adhesive process by the claimed method was carried out on the basis of the MUZ "Maternity hospital No. 5" in Krasnoyarsk in 10 puerperas, which made up the main study group. The control group consisted of 7 women who were terminated by caesarean section in the full term of pregnancy, but they did not perform adhesion prophylaxis in the postoperative period.

All patients had a full-term gestation period of 37 to 40 weeks, of which 11 patients were operated on as planned, 6 patients on an emergency basis. Indications for surgery are presented in table 1. All women were registered for pregnancy, examined. In the history of 1 patient of the study group, there was infertility, surgical intervention for subserous uterine fibroids in 2005 with transverse suprapubic laparotomy by Pfannenshtil incision, myomectomy of 3 subserous nodes, suturing of the serosal bed with a continuous vicryl suture, layer-by-layer closure of the anterior abdominal wall .

Table 1 Indications for surgery on the pelvic organs Indications for operative delivery Number of patients Scheduled operation Emergency operation Birth-born age over 30 years in combination with obstetric and extragenital pathology 3 Pelvic presentation of the fetus, with a fetal body weight of more than 3500 g 2 Uterus scar after conservative myomectomy combined with infertility one Severe forms of gestosis in the absence of the effect of conservative therapy 2 Placental presentation one Multiple pregnancy after IVF one Multiple pregnancy with pelvic presentation of the first fetus one Premature discharge of amniotic fluid and lack of effect from labor excitement 3 Anomalies of labor, not amenable to drug correction 2 Weak labor and the woman’s refusal of birth control one

The postoperative period in this case proceeded without complications. In 1 patient of the main group at the age of 33 years, there was also a history of infertility due to polycystic ovary, pregnancy occurred after stimulation of the ovulation process with clomiphene. In 1 patient of the control group, a prolonged tube infertility was followed by in vitro fertilization (IVF), and a multiple pregnancy developed.

All patients of the main group underwent a laparotomy with a Pfannenstiel incision, a cesarean section was made in a transverse incision in the lower uterine segment (4 patients using the Gusakov method, 6 patients using the Defler method), a double-row continuous vicryl suture was applied to the uterine wall, and serous vesicoureteral folds were sutured. continuous single-row vikrilovy seam. Then, after closing the peritoneal section with a continuous vikril seam, a sponge containing 2% collagen acetate, 2% chitosan ascorbate with a deacetylation degree of more than 95%, molecular weight from 100 to 700 kDa, ascorbic acid - 1.8 g / g was introduced into the preperitoneal tissue dry chitosan, chondroitinsulfuric acid - 5-100 mg / g dry chitosan, hyaluronic acid - 10-100 mg / g dry chitosan, heparin -2.5-5 mg / g dry chitosan and serum cattle growth factor "gelon" - 11-220 μg / g dry chitosan, dimensions 60 × 100 × 4 mm, then layered the muscle layer and aponeurosis of the anterior abdominal wall were sutured, the same sponge was inserted into the space between the muscle-aponeurotic layer and subcutaneous fat, the layer of subcutaneous fat and skin were sutured tightly with separate nodular nylon sutures.

Patients in the control group underwent a laparotomy with a Pfannenstiel incision, a cesarean section was made in a transverse incision in the lower uterine segment (2 patients using the Gusakov method, 5 patients using the Defler method), a double-row continuous vicryl suture was applied to the uterine wall, and serous cystic-vesiculate uterine suture was closed. single row vikrilovy seam. Then, the incision of the parietal peritoneum of the anterior abdominal wall is sutured with a continuous vikril suture, then the muscle layer and aponeurosis, subcutaneous fatty tissue and skin are sutured with separate knotted nylon seams in layers of individual vikril sutures.

The postoperative period in all patients of the main study group proceeded without complications, 2 patients in the control group of the study developed postoperative suture seroma, 1 patient of the same group developed adhesive intestinal obstruction, stopped by conservative treatment methods.

In a comprehensive blood test in the postoperative period in the main group of the study, the blood test had a clear positive trend and at the time of discharge on the 7th day of postoperative intervention was within normal limits. In the control group of the study, two patients on the 7th day after the operation recorded an increased number of leukocytes in the peripheral blood. The same patients were discharged from the maternity hospital on the 10th day of the postoperative period after stopping the local inflammatory process in the postoperative wound and normalizing peripheral blood counts. A detailed blood test in the dynamics of the postoperative period in the study groups is presented in table 2. As can be seen from table 2, in the main group of the study in the postoperative period, positive laboratory dynamics were noted: the number of leukocytes returned to normal compared to the control group, the blood leukoform, and the sedimentation rate decreased red blood cells, normalized concentration of C-reactive protein (CRP). On the 7th day of the postoperative period, the response to CRP was negative in the study group and moderate in the control group. This indicates a more rapid relief of the inflammatory process in the area of surgical intervention.

table 2 The dynamics of peripheral blood in the postoperative period Blood counts The main group (n = 10) Control group (n = 7) Norm before surgery 3 day 5 day 7 day before the opera
tions 3 day 5 day 7 day 10 day White blood cells, 10 ⁹ / l 7.6 6.6 5,4 4.2 7.2 6.8 6.6 5.8 5,4 4-6 - sticks% four 3 2 2 8 6 four 2 2 3-6 - segmented% 78 72 68 62 76 74 72 68 68 51-67 - young% - - - - - - - - - Lymphocytes,% 24 twenty eighteen eighteen 26 24 twenty twenty twenty 23-42 Basophils% one one 2 one one one 2 one one 0-1 Eosinophils% 0 0 0 0 0 0 0 0 0 1-2 HB, mg% 124 122 136 138 120 116 one hundred 98 98 ESR mm / h 45 32 28 eighteen 48 46 40 36 28 Up to 12 C-reactive protein (qualitative reaction) ++ + + - ++ ++ +++ +++ ++ - CRP - negative reaction
+ CRP - the reaction is weak
++ CRP - the reaction is moderate
+++ CRP - the reaction is very pronounced

All patients of the main study group were discharged home with the child on the 7th day of the postoperative period, while in the control group 2 patients with postoperative suture seroma were in the maternity hospital for up to 10 days.

Further, after discharge from the maternity hospital, women were found to be observed on an outpatient basis - the patronage of the antenatal clinic. After one month, all patients underwent a gynecological examination. In the main group, during vaginal examination, it was found that the uterus is of normal size, in the anteflexio position, with clear contours, mobile, of normal consistency, palpation in the suture area on the uterus is painless, uterine appendages on both sides are not clearly contoured, palpation in the area of their projection is painless, the vaginal arches are free and deep, the postoperative suture on the skin is smooth, elastic, painless. In the control group of the study, in two patients, the size of the uterus was larger than normal, the uterus was painless on palpation, uterine mobility was limited due to adhesions, uterine appendages were soldered to the lateral surfaces of the uterus, their mobility was limited, there are signs of shortening of the vaginal arches. In the remaining patients of the control group, vaginal status was within normal limits. Postoperative skin suture is painless, inactive.

Ultrasound examination of patients of the main group showed that all echo parameters were normal; in the control group, two patients revealed indirect signs of an adhesive process in the small pelvis.

Clinical example. Patient B., 32 years old, was admitted to the birth ward with regular labor. Third pregnancy, the first forthcoming birth, previous pregnancies ended in spontaneous miscarriages in the early stages. The cause of spontaneous miscarriages has not been established.

Upon admission to the maternity hospital after an initial examination, the diagnosis is: pregnancy 39-40 weeks; first birth at the age of 32; burdened obstetric history (OAA); the beginning of the first period of labor.

The birth plan is drawn up for childbirth through the natural birth canal under the control of the heart tones of the fetus by the dynamics of labor.

After the initial examination, after three hours, a decrease in the frequency and strength of contractions was recorded. A vaginal examination showed slight dynamics of cervical dilatation. Diagnosed with primary weakness of labor. An amniotomy was performed on this subject. When re-examined after 3 hours, the contractions are weak, the vaginal status is the same. Considering the first forthcoming birth at the age of 32 years, OAA, the presence of primary weakness of labor, the refusal of birth control by oxytocin (intravenous, drip), it was decided to urgently deliver the cesarean section with surgery.

Under epidural anesthesia, a laparotomy was performed according to Pfannenstiel, a caesarean section in the lower uterine segment according to Defler, a fetus weighing 3560 g, 54 cm tall, was extracted with an Apgar score of 8-9 points. The incision on the uterus is sutured with a double-row continuous vikril seam, peritonization due to the vesicoureteral fold. After sanitation of the abdominal cavity, counting napkins, and instruments, the peritoneum was sutured with a continuous vikril seam. A sponge containing 2% collagen acetate, 2% chitosan ascorbate with a degree of deacetylation of more than 95%, molecular weight from 100 to 700 kDa, ascorbic acid - 1.8 g / g dry chitosan, chondroitersin acid - 5-100 mg / g dry chitosan, hyaluronic acid - 10-100 mg / g dry chitosan, heparin -2.5-5 mg / g dry chitosan and serum growth factor cattle "gelon" - 11-220 μg / g dry chitosan, sizes 60 × 100 × 4 mm, then the muscle layer and the aponeurosis of the anterior abdominal wall are stitched in layers between musculoaponeurotic layer and the subcutaneous fatty tissue introduced the same sponge sewn subcutaneous fat layer and skin of individual nodes kapron sutures tight. Total blood loss was 500 ml. The postoperative period was uneventful, body temperature returned to normal on the 2nd day. The leukocyte formula returned to normal on the 5th day, the white blood cells left 5.6 × 10 ⁹ , the CRP reaction on the 5th day was weak. In the area of postoperative sutures, there were no infiltrative and inflammatory phenomena. In the morning on the 7th day postoperative sutures were removed, healing by primary intention. The postpartum woman was discharged home with her child on the 7th day. Observation was conducted in the conditions of a antenatal clinic. The patient has no complaints. Feels good. After 1 month, a vaginal examination was performed: the body of the uterus is normal in size, with clear contours, mobile, painless. Appendages on both sides are not clearly defined. The vaults are free, deep. Ultrasound echopathology was not detected. The peripheral blood picture was normal. Thus, the proposed method prevents the development of adhesions in the peritoneal cavity of the pelvis during obstetric and gynecological operations, provides for the location of the chitosan composition in the immediate vicinity of the peritoneal cover, prevents the development of exudative processes in the tissues of the postoperative wound and accelerates the healing time.

Literature

1. Zhenchevsky R.A. Adhesive disease. - Moscow, 1989.

2. Application No. 2002103330, IPC ⁷ АВВ 17/00, А61К 31/74, А61Р 41/00, 03/10/2004.

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Claims (1)

A method for the prevention of adhesions in the peritoneal cavity during obstetric and gynecological operations, including the use of compositions based on chitosan, characterized in that the composition is applied by layer-by-layer suturing of the surgical wound into the preperitoneal and subcutaneous tissue of the anterior abdominal wall, the composition being a sponge of 60 × 100 × 4 mm to 240 × 180 × 4 mm, which contains 2% collagen acetate, 2% chitosan ascorbate with a deacetylation degree of more than 95%, a molecular weight of 100 to 700 kDa, ascorbic acid 1.8 g / dry chitosan, chondroitin sulfuric acid - 5-100 mg / g dry chitosan, hyaluronic acid - 10-100 mg / g dry chitosan, heparin - 2.5-5 mg / g dry chitosan and serum cattle growth factor "gelon" - 11-220 mcg / g dry chitosan.