RU2795077C1 - Method for implantation and fixation of a polypropylene sleeve-implant during the formation of a gastrostomy - Google Patents

Abstract

FIELD: medicine; surgery; gastroenterology.

SUBSTANCE: stomach is brought out into the laparotomy wound. A stem gastrostomy is formed. In the left hypochondrium in the projection of the rectus abdominis muscle, a wound channel is formed, through which the gastrostomy is brought out to the skin of the anterior abdominal wall. The diameter of the gastrostomy is measured in the zone of its adjoining to the aponeurosis of the anterior abdominal wall and the thickness of the subcutaneous fat. A sleeve-implant is formed from a polypropylene mesh, for which a trapezoidal blank of the sleeve-implant is cut out and folded in the form of a truncated cone, while the height of the formed sleeve-implant is not more than half the thickness of the subcutaneous fat layer. The sleeve-implant is placed from the side of the skin on the gastrostomy with partial placement of the tissue of the sleeve-implant on the tissue of the anterior abdominal wall aponeurosis and is fixed to the aponeurosis of the anterior abdominal wall with involvement of the gastrostomy serous-muscular tissues in the nodal suture. The gastrostomy is additionally fixed to the skin of the wound channel.

EFFECT: method reduces the risk of gastrostomy failure and the formation of adhesive process of the abdominal organs in the postoperative period due to the placement of the sleeve-implant on the outer side of the anterior abdominal wall, which excludes contact of the material of the sleeve-implant with internal organs, reduces the risk of postoperative complications in the postoperative period.

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Description

The invention relates to medicine, namely to surgical methods for the formation and fixation of a gastrostomy, and can be used in the surgical practice of medical institutions with surgical hospitals.

A known method of forming a gastrostomy according to Depage-Janeway using the GIA apparatus (Operative Pediatric Surgery, Seventh Edition. Editor Lewis Spitz, Arnold Coran page 44). This method is taken as an analogue method. In the course of this method, an upper median laparotomy (opening of the abdominal cavity) is performed. The anterior wall of the stomach is pulled into the wound with two Babcock clamps to form a gastric tube 8-10 cm long. In addition, the diameter of the tube must be calculated so that it allows the insertion and removal of an 18-22F Foley catheter for feeding the patient. The stapler (GIA-60) is placed perpendicular to the wall of the stomach in the area of its greatest curvature so that the hardware suture ends 25 mm from the indicated area. The device operates leaving 4 rows of sutures, 2 on each side in a double variable line of staples. At the same time, the GIA knife cuts the stomach between both double rows of sutures, forming a closed gastric tube in the form of a diverticulum (stalk) with a base at the greater curvature of the stomach wall. The hardware suture is immersed with separate interrupted sutures with a synthetic absorbable thread. To the left of the median incision in the projection of the left rectus abdominis muscle, a hole of 30-50 mm in size is made and the formed gastric tube is passed through it. To do this, an Allis clamp is passed through the wound and, capturing the end of the tube, they bring it out. The stomach is sutured to the parietal peritoneum to avoid strain on the tube. The end of the formed gastric diverticulum is dissected, bleeding is stopped, a 18-22F Foley catheter is inserted to feed the patient and left in place for one week. The edges of the gastric tube are sutured to the skin with absorbable synthetic threads. This method provides mechanical fixation of the stomach to the anterior abdominal wall, which prevents leakage of gastric contents into the abdominal cavity. However, with all the undoubted advantages of this analogue method, it still has a number of significant drawbacks associated with insufficient reliability of gastrostomy fixation in the tissues of the anterior abdominal wall, which is due to the peculiarities of the formation of mature connective tissue in various parts of the anterior abdominal wall, especially in weakened, cachexic cancer patients with reduced reparative processes.

There is a known method for performing gastrostomy using a polypropylene mesh (patent RU No. 2691924 publ. 06/18/2019). This analogue method is characterized by the fact that, after making access by performing a median laparotomy, two implants are modeled, which are made of a polypropylene mesh. The first implant is made in the form of an oval-shaped plate with a central hole, and the second implant is made in the form of at least a single-layer mesh sleeve-implant and covers the formed gastrostomy. The gastric tube is passed through the central hole of the first implant, after which the second implant is put on it, made in the form of a sleeve. The first implant is fixed to the wall of the stomach, and the second - to the gastric tube, after which the implants are sutured together. The gastric tube covered by the second implant is brought to the anterior abdominal wall to the left of the median incision in the projection of the left rectus abdominis muscle through a 15-20 mm hole. At the end of the operation, the gastric tube is fixed with sutures to the parietal peritoneum and the muscular-aponeurotic layer. This analogue method, due to the use of a polypropylene mesh, provides reliable fixation of the stomach to the peritoneum, which prevents leakage of gastric contents into the abdominal cavity, significantly reduces the risk of gastrostomy failure, however, with all the undoubted advantages of the analogue method, it still has a number of significant drawbacks, the main of which is the presence of two synthetic implants in the abdominal cavity, placed partly on the anterior wall of the stomach and partly on the basis of the gastrostomy. This may be accompanied by the development of a pronounced adhesive process in the area of fixation of polypropylene meshes on the stomach and on the base of the gastrostomy, in which contact of these meshes with other hollow organs of the abdominal cavity (small, large intestine) is not excluded, which can lead, in some cases, to intestinal obstruction in the immediate or late postoperative periods.

A method is known for performing laparoscopic gastrostomy using a polypropylene mesh sleeve-implant (patent RU No. 2748881 publ. 06/01/2021). By the combination of essential features, in terms of the formation and fixation of the stem gastrostomy, this analogue is the closest to the patented method and, therefore, is taken as its prototype. The prototype method is characterized by the fact that using endovideosurgical equipment, after installing trocars, a place is determined for applying a gastrostomy and, using clamps, the stomach wall is captured along the greater curvature. After that, an endoscopic apparatus of a linear suture is inserted through the appropriate trocar and brought under the clamps, positioning it in such a way that, after crossing the stomach wall, a cone-shaped gastric tube is formed, the size of which is sufficient to form a gastrostomy. Next, a cone-shaped polypropylene mesh sleeve-implant is prepared, the dimensions of which allow to completely cover the gastric tube at its base, while the height of the mesh corresponds to 1/5 of the length of the said tube. The sleeve-implant is placed in the abdominal cavity. The gastric tube is passed through the central hole of the sleeve-implant. Through a 10 mm trocar installed in the left hypochondrium, a clamp is inserted, which captures the end of the gastrostomy. The gastrostomy, captured by the clamp, is pulled into a 10 mm trocar installed in the left hypochondrium, and pulled out to the anterior abdominal wall through the channel of the removed 10 mm trocar. The gastric tube is pulled up and fixed with interrupted sutures to the skin with a surgical thread. The trocars are removed, the sutures are applied to the skin with a surgical thread. The gastric tube is cut with scissors so that the tube protrudes above the skin, forming a functioning gastrostomy. A Foley catheter is inserted through the gastrostomy into the lumen of the stomach to feed the patient, which completes the stage of formation of the gastrostomy. The prototype method, due to the use of a polypropylene mesh sleeve-implant, provides reliable fixation of the stomach to the anterior abdominal wall, which prevents leakage of gastric contents into the abdominal cavity. However, this method, with all its undoubted advantages, still has a number of significant drawbacks, which are mainly associated with the location of the polypropylene sleeve-implant in the abdominal cavity. The placement of the sleeve-implant on the basis of the gastrostomy without its clear fixation, with the subsequent movement of the gastrostomy into the wound channel of the anterior abdominal wall, does not exclude the possibility of its displacement and deformation in the tissues, and the presence of a synthetic polymer or its fibers in the abdominal cavity can cause the development of the adhesive process of the sleeve - an implant with other hollow organs of the abdominal cavity (small, large intestine) in the area of the implant sleeve, since it is placed on the basis of the gastrostomy from the side of the abdominal cavity. This is fraught with the possible formation of acute intestinal obstruction in the immediate or late postoperative period. As a significant drawback of the prototype method, it should also be noted that the laparoscopic formation of the stem gastrostomy implies the need for endotracheal anesthesia and the availability of expensive endovideosurgical equipment. In addition, the removal of the gastrostomy through the opening of the 10 mm trocar in some cases can lead to mechanical ischemia of the gastrostomy in the tissues of the anterior abdominal wall, followed by its necrosis.

The problem, the solution of which is aimed at the “Method of implantation and fixation of a polypropylene sleeve-implant during the formation of a gastrostomy” claimed as an invention, is the insufficiently satisfactory results of the use of analogue methods in the treatment of patients in need of the formation of a gastrostomy, in whom, due to severe cachexia or prolonged oncological intoxication, as a rule, there is a decrease in reparative processes. The patented method can significantly improve the results of surgical treatment of this particular category of patients, in the first place.

When using the invention, a combination of the following important technical results is achieved:

Reduces the risk of gastrostomy failure.

The risk of formation of adhesive process of the abdominal organs in the postoperative period is reduced.

Reduces the risk of postoperative complications in the postoperative period.

The essence of the patent-pending method of implantation and fixation of a polypropylene sleeve-implant during the formation of a gastrostomy is the sequential implementation of the following steps:

- perform upper median laparotomy;

- the stomach is removed into the laparotomic wound;

- form a stem gastrostomy using a stapler;

- in the left hypochondrium in the projection of the rectus abdominis muscle, a wound channel with a diameter of 30-50 mm is formed to remove the gastrostomy through it;

- through the formed channel with the help of a clamp, the gastrostomy is removed to the skin of the anterior abdominal wall, the diameter of the gastrostomy is measured in the zone of its adjoining to the aponeurosis of the anterior abdominal wall and the thickness of the subcutaneous fat;

- in accordance with the diameter of the gastrostomy in the area of its contact with the aponeurosis of the anterior abdominal wall and the thickness of the patient's subcutaneous fat, a sleeve-implant is formed from a polypropylene mesh;

- under visual control using Farabeus hooks, the sleeve-implant is placed from the side of the skin on the gastrostomy with partial placement of the tissue of the sleeve-implant on the tissue of the aponeurosis of the anterior abdominal wall;

- the sleeve-implant is fixed with three interrupted sutures along the circumference with a non-absorbable polypropylene thread to the aponeurosis of the anterior abdominal wall with involvement of the gastrostomy serous-muscular tissues in the interrupted suture;

- the gastrostomy is additionally fixed with three interrupted sutures with a non-absorbable thread along the circumference to the skin of the wound canal, the end of the gastrostomy is cut off with scissors so that it protrudes above the skin by at least 10 mm, forming a functioning gastrostomy, into which a Foley catheter is inserted;

- the laparotomic wound is sutured in layers.

The essence of the invention is illustrated by drawings

On FIG. 1 schematically shows the stomach with a stalk gastrostomy formed from its anterior wall.

On FIG. 2 schematically shows a pattern of a blank made of polypropylene mesh for forming a sleeve-implant.

On FIG. 3 schematically shows the formed sleeve-implant.

On FIG. 4 schematically shows the location of the sleeve-implant on the gastrostomy and its fixation to the aponerosis of the anterior abdominal wall and to the skin of the wound channel with interrupted sutures.

The method of implantation and fixation of a polypropylene sleeve - an implant during the formation of a gastrostomy is carried out as follows:

After the protocol preparation of the patient for performing abdominal surgery, an upper median laparotomy is performed (see, for example, R.M. Zollinger, R.M. Zollinger., edited by V.A. Kubyshkin "Atlas of Surgical Operations" P. 36, Geotar-Media publishing house, Moscow , 2009). Next, the abdominal organs are inspected, the stomach (1) is removed into the laparotomy wound along its greater curvature using a GIA-60 stapler (not shown), a stem gastrostomy (2) is formed (see Fig. 1). After that, in the left hypochondrium in the projection of the middle of the left rectus abdominis muscle, a through wound channel with a diameter of 30-50 mm is formed through which the gastrostomy (2) is removed using an Allis clamp (not shown). Under visual control, using Farabeus hooks and an elastic sterile ruler (not shown), the diameter of the gastrostomy (2) is measured in the zone of its adjoining to the aponeurosis (3) of the anterior abdominal wall, as well as the thickness of the subcutaneous fat (4) of the wound channel. This manipulation makes it possible to more accurately form the dimensions of the sleeve-implant (5), i.e. its diameter, taper and height. In accordance with the obtained dimensions, a trapezoidal blank (6) of the implant coupling (5) is cut out and folded in the form of a truncated cone (see Fig. 2, Fig. 3) so that at its base it is adjacent to the aponeurosis (3) the anterior abdominal wall by 1-2 mm, and exceeded the diameter of the gastrostomy (2) by 2-3 mm in all its parts. The height of the sleeve-implant (5) formed in this way should not exceed half the thickness of the subcutaneous fat layer (4) of the patient. The edges of the sleeve-implant (5) are sutured with two interrupted sutures (7) with a non-absorbable polypropylene thread (trademarks Surgipro, Prolen) with a conditional diameter of 2/0 on a piercing needle of 21-22 mm ½ of the circumference (see Fig. 2). As a material for the manufacture of the sleeve-implant (5), a standard sterile polypropylene mesh is used for the surgical treatment of abdominal hernias (trademarks Lintex, Etikon, Volot). The sleeve-implant (5) (see Fig. 4) is placed on the gastrostomy (2) so that it is located partially on the aponeurosis (3) of the anterior abdominal wall by 1-2 mm, after which the sleeve-implant (5) is fixed with three interrupted sutures (8) with a non-absorbable synthetic thread based on polypropylene (Surgipro, Prolen) with a conditional diameter of 2/0 on a pricking needle 21-22 mm ½ of the circumference along the diameter of the gastrostomy stem (2) with involvement of the aponeurosis tissue (3) in the suture, actually sleeve-implant (5) and serous-muscular membrane of the gastrostomy (2) (see Fig. 4). Then, for the purpose of additional fixation of the gastrostomy (2), three more interrupted sutures (9) are formed with a non-absorbable synthetic thread based on polypropylene (Surgipro, Prolen) with a conditional diameter of 2/0 on a piercing needle of 21-22 mm ½ of the circumference between the skin of the wound channel itself and seromuscular membrane of the gastrostomy (2) (see Fig. 4). After that, the gastrostomy (2) is cut with scissors so that its end protrudes above the skin by at least 10 mm, forming a final functioning gastrostomy, through which a Foley catheter (not shown) is inserted into the lumen of the stomach (1) to feed the patient. The operation according to the patented method is completed by applying standard surgical sutures to the laparotomic wound, (see, for example, R.M. Zollinger, R.M. Zollinger., edited by V.A. Kubyshkin "Atlas of Surgical Operations" P. 38, publishing house "Geotar-Media", Moscow , 2009).

The fundamental differences between the patented method and its closest analogues, which provide better final results of gastrostomy in comparison with them for the above categories of patients and ensure the achievement of the totality of the claimed technical results, is that:

- the sleeve-implant (5) is fixed in the wound channel after the removal of the gastrostomy (2) to the skin, which excludes the contact of the material of the sleeve-implant with the internal organs and the initiation of the adhesive process from the abdominal organs;

- the sleeve-implant (5) in the wound channel is sutured to the aponeurosis (3) and gastrostomy (2) with three interrupted sutures (8) under visual control using Farabef hooks, additionally, the gastrostomy is fixed to the skin with three interrupted sutures (9), which achieves stable fixation of the gastrostomy (2) in the tissues of the anterior abdominal wall;

- in the course of the patented method, unlike its analogues, the diameter and height of the sleeve-implant (5) can be selected individually during the operation, depending on the diameter of the gastrostomy (2) and the thickness of the subcutaneous fat (4) of the patient, thus so as not to cause ischemia of the gastrostomy and not to promote the formation of inflammatory seromas from the side of the subcutaneous fat (4) in the area of the sleeve-implant (5).

Moreover, all the claimed technical results are interconnected and with the essence of the patented method as follows:

- the risk of gastrostomy failure is reduced due to the formation of mature connective tissue in the area of the sleeve-implant (5), which was confirmed in experimental studies on chinchilla rabbits. (A.G. Vaganov, A.Z Tsulaya, L.V. Safonov, S.N. Shurygin, V.V. Krishtop, V.G. Nikonorova “Cellular-tissue complexes of the gastrostomy zone”, Modern problems of science and education, 2020, No. 2);

- the risk of formation of adhesions of the abdominal organs in the postoperative period is reduced due to the placement of the sleeve-implant (5) not inside the patient's abdominal cavity, but on the outside of the anterior abdominal wall along the wound channel on the aponeurosis (3) and gastrostomy tissue (2), with subcutaneous fat adjacent to them (4), which eliminates the contact of the implant sleeve material with internal organs

- the risk of postoperative complications in the postoperative period is reduced due to the possibility of performing the operation both under general anesthesia and under local infiltration anesthesia. The latter is especially important for patients with a high operational risk, with reduced reparative processes, suffering from severe cachexia and prolonged oncological intoxication.

The patented method of implantation and fixation of a polypropylene sleeve-implant during the formation of a gastrostomy is clinically applicable, because for its implementation in modern medical institutions with surgical hospitals, all the necessary materials, equipment and tools are available. The practical achievement of the totality of the claimed technical results is fully confirmed by an experimental study, which convincingly proves a favorable morphological reaction of tissues in the zone of formation of the implant sleeve (5). The study was conducted on 18 chinchilla rabbits, with the study of the results on days 7, 14 and 21 from the moment of the operation: (A.G. Vaganov, A.Z Tsulaya, L.V. Safonov, S.N. Shurygin, V. V. Krishtop, V. G. Nikonorova "Cell-tissue complexes of the gastrostomy zone", Modern problems of science and education, 2020, No. 2), as well as S. Shurygin, A. Vaganov, A. Tsulaya et al "Morfologian Substantiation for the effectiveness of the Propored Method of Gastrostomy using a Polypropylene Endoprosthesis)) p.45-49, International Journal of Biomedicine, USA, 2020, 10(1).

Claims (11)

A method for implantation and fixation of a polypropylene sleeve-implant during the formation of a gastrostomy, which consists in the sequential implementation of the following steps: - perform upper median laparotomy; - the stomach is removed into the laparotomic wound; - form a stem gastrostomy using a stapler; - in the left hypochondrium in the projection of the rectus abdominis muscle, a wound channel with a diameter of 30-50 mm is formed; - through the formed channel with the help of a clamp, the gastrostomy is removed to the skin of the anterior abdominal wall, the diameter of the gastrostomy is measured in the zone of its adjoining to the aponeurosis of the anterior abdominal wall and the thickness of the subcutaneous fat; - in accordance with the diameter of the gastrostomy in the zone of its adjoining to the aponeurosis of the anterior abdominal wall and the thickness of the subcutaneous fat of the patient, a sleeve-implant is formed from a polypropylene mesh, for which a trapezoidal blank of the sleeve-implant is cut out and folded in the form of a truncated cone, while the height of the formed sleeve-implant not more than half the thickness of the layer of subcutaneous fat; - under visual control using Farabeus hooks, the sleeve-implant is placed from the side of the skin on the gastrostomy with partial placement of the tissue of the sleeve-implant on the tissue of the aponeurosis of the anterior abdominal wall; - the sleeve-implant is fixed with three interrupted sutures along the circumference with a non-absorbable polypropylene thread to the aponeurosis of the anterior abdominal wall with involvement of the gastrostomy serous-muscular tissues in the interrupted suture; - the gastrostomy is additionally fixed with three interrupted sutures with a non-absorbable thread along the circumference to the skin of the wound channel, the end of the gastrostomy is cut off with scissors so that it protrudes above the skin by at least 10 mm, forming a functioning gastrostomy, into which a Foley catheter is inserted; - the laparotomic wound is sutured in layers.

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