RU2826837C1 - Method of treating hysteroptosis using mesh polypropylene implant - Google Patents

Abstract

FIELD: medicine; urogynecology.

SUBSTANCE: longitudinal incision of a posterior vaginal wall and an underlying fascia is performed, starting from a posterior fornix, with length of 25–30 mm, with a forefinger forming pararectal translator canals to ischial spines on both sides. Anterior surface of the sacrospinal ligaments is exposed. Rectum and pararectal fat are displaced medially, using a transsacrospinal trocar, according to the principle from the inside out, the sacrospinal ligament is punctured in the area of its inner one-third in the middle of its width, then along the trocar—the sacrotuberal ligament, gluteal muscles, subcutaneous fat and skin of the gluteal region, during puncture of sacrospinal ligament with index finger located between trocar and lateral wall of rectum, the latter is insured against damage, provisional guide suture is delivered through puncture. Trocar is removed; a similar manipulation is performed from the opposite side; a transverse incision of the anterior wall of the vagina is made at the level of the uterine isthmus. Using an anterior transobturator trocar, a provisional guide suture is delivered from both sides around the cervix. Then, having fixed the prosthesis to the sutures, it is carried out around the cervix, the middle part of the mesh prosthesis is fixed to the anterior surface of cervix for 3 cm with a non-absorbable continuous ethibond 1–0 suture. "Sleeves" of the prosthesis are delivered through the sacrospinal ligaments according to the in-out method onto the gluteal region in a state of tension, both vaginal incisions are closed with absorbable suture material 3–0. At the end of the operation, the implant tape sleeves are pulled up with simultaneous lifting and returning to their physiological positions of the uterus, posterior wall of the vagina and its dome.

EFFECT: method enables restoring the anatomy of the pelvic floor, adequate urination and sexual activity, as well as improving the quality of life in women in general.

2 cl, 2 ex

Description

The invention relates to the field of medicine, namely, to urogynecology, and can be used for surgical treatment of hysteroptosis.

Hysteroptosis or prolapse of the uterus is a disease that occurs as a result of failure of the ligamentous and fascial apparatus of the pelvic floor. Often, prolapse of the uterus is accompanied by prolapse of the vaginal walls with the bladder and rectum (cystocele, rectocele), however, the disease also occurs in isolation. Up to 20% of all gynecological surgeries are for correction of prolapse of the uterus.

According to world statistics, uterine prolapse is diagnosed in 14% of women. Another American study, which included 149,554 women, showed that the risk of surgical intervention for prolapse during life is 11%.

A UK study by the Oxford Family Planning Association found that more than 17,000 women aged 25-39 were diagnosed with prolapsed uterus.

The most effective method of treating pelvic prolapse is surgical. Despite the numerous techniques, there is no universal operation that solves all prolapse problems, the frequency of relapses of the disease is high, so surgeons tirelessly continue to develop new methods, the use of which, sometimes in combination with each other, allows to obtain not only good, but also stable results.

A method for surgical treatment of anterior apical genital prolapse is known (RU, patent 2727758, published 23.07.2020), which is carried out by reconstructing the pelvic floor with a polypropylene implant using a combined approach. A vaginal speculum is inserted into the vagina, the cervix is fixed with bullet forceps. Hydropreparation of the tissues of the anterior vaginal wall is performed with a physiological NaCl solution in an average volume of forty milliliters with the introduction of the latter under the pubocervical fascia. An incision is made in the anterior vaginal wall with a mandatory dissection of the vaginal mucosa and the pubocervical fascia, retreating two to three centimeters proximal to the external opening of the urethra, not reaching the external os of the cervix by one and a half to two centimeters. The bladder is separated from the uterus by sharp and blunt means. A wide mobilization of the posterior wall of the urinary bladder and its lateral (right and left) sides is performed. The paravaginal space is exposed, the cellular space around the obturator foramina is opened. The lower branches of the pubic bones on both sides, the bony tubercle of the ischium, and the tendinous arches of the intrapelvic fascia are manually identified. Skin incisions of about 0.8 cm in length are made in the area of the left inguinal-femoral fold at the level of the clitoris. Next, under the control of the index finger, a guide needle with a cannula (tubular guides) is used to perforate the membrane of the obturator foramen 5 on the left along the anteromedial edge, the needle is removed. As a result, one end of the tubular guide comes out through the skin of the inguinal-femoral fold, the second, perforating the membrane of the obturator foramen, comes out through the vagina. A special guide is installed on the right in a similar manner. Retractors of the polypropylene mesh sleeves are installed through the tubular guides (cannulas). The peritoneum is identified and opened in the area of the vesicouterine fold. The future implant is cut out of ultra-light polypropylene mesh (surface density 19 g/m2) in the shape of an isosceles trapezoid with individual dimensions for each patient. The height of the implant trapezoid is equal to the distance from the introitus to the apex of the vaginal dome. The wide base of the trapezoid (the front part of the implant) is equal to half the transverse size of the pelvic outlet (the distance between the inner surfaces of the ischial tuberosities) plus two centimeters. The narrow base (the back part of the implant) is equal to the width of the cervix plus two centimeters. Sleeves for the implant in the form of three strips are made of polypropylene mesh (surface density 40-60 g/m2). The front sleeves are made in the form of two strips with the same dimensions: 1 centimeter wide and 10 centimeters long. The back sleeves are made in the form of a strip 1 centimeter wide and 20 centimeters long. The narrow base of the trapezoidal implant is fixed to the middle of the strip with separate interrupted sutures of non-absorbable 2/0 prolene thread. Two polypropylene sleeves are fixed symmetrically to the corners of the wide base of the trapezoidal implant with separate interrupted sutures of non-absorbable 2/0 prolene thread: one on the right, the other on the left. The middle of the anterior part of the polypropylene implant is fixed to the pubocervical fascia at the anterior vaginal incision with an interrupted suture of absorbable thread (PGA 2/0, Vicryl 2/0, USP 2/0), and the middle of the posterior part of the implant is fixed to the cervix (or vaginal stump in the absence of a cervix) with interrupted sutures of non-absorbable suture material (e.g., prolene 2/0, monofilament 2/0, PDS). The left and right sleeves of the anterior part of the implant are passed with retractors inside the tubular conductors (cannulas) - from the inside (from the vaginal side) to the outside. The sleeves of the posterior part of the polypropylene implant are brought out into the abdominal cavity. The mesh polypropylene implant is finally straightened and installed without tension under the posterior wall of the bladder. The vaginal mucosa is sutured with a continuous suture of absorbable suture material (for example, PGA 1, Vicryl 1, USP 1) without excision of the "excess" vaginal mucosa. The tubular conductors (cannulas) are removed. The excess sleeves of the mesh prosthesis are cut off subcutaneously. The vagina is tightly tamponed with sterile napkins moistened with a furacilin solution or physiological NaCl solution. A lower median laparotomy or laparoscopy is performed. In laparoscopic access, a ^CO2 peritoneum is applied through an umbilical puncture with a Veress needle and a 10 mm trocar with a 30° laparoscope is inserted. Survey laparoscopy is performed. The posterior sleeves of the polypropylene mesh are visualized. Five-millimeter and twelve-millimeter trocars are inserted at standard points. The peritoneum is opened from the exit point of the polypropylene sleeves of the implant (from the previously opened peritoneum in the area of the vesicouterine fold) along the round ligaments of the uterus to the iliac-obturator region on the right and left. Anatomical landmarks are visualized on both sides - the iliac vein, the obturator nerve, Cooper's ligament (ligamentum iliopectineale). The posterior sleeves of the polypropylene mesh are fixed to Cooper's ligament using a herniostapler or separate sutures with non-absorbable suture material. The cervix and vagina are fixed in a "hammock" shape. The mesh is peritonized with a continuous suture of absorbable suture material. The trocar wounds are sutured.

The disadvantage of this method of surgical treatment of prolapse is the need for two approaches: transvaginal and laparoscopic, which increases the risk of complications and the trauma of the operation.

Also known (RU, RF patent 2612518, published 09.03.2018) is a method of laparoscopic promontofixation, including punctures of the anterior abdominal wall in the paraumbilical region, in the epigastric region and along the line connecting the spines of the ischial bones, the introduction of trocars into the abdominal cavity, an incision of the parietal peritoneum in the direction from the sacral promontory to the isthmus of the uterus in the area of fixation of the uterosacral ligaments, the formation of a tunnel partially sharp, partially bluntly in the subperitoneal tissue, the introduction of a mesh implant into the cavity, wherein an implant with a tapered end and a U-shaped split end is cut out of a rectangular prolene mesh, the tapered end is fixed to the presacral fascia with separate interrupted sutures, the U-shaped split end is fixed to the uterosacral ligaments on both sides and to the isthmus uterus, peritonization of the implant is performed with sheets of peritoneum, the operation is combined with plastic surgery of the sacrouterine ligaments according to MacCoul, obliteration of the retrouterine space in the modification of Moschcowitz, colpoperineo-levatoroplasty.

The disadvantage of the known method is the need for general anesthesia and the risk of injury to the vessels of the presacral region with potential subsequent uncontrolled bleeding, the risk of injury to vital structures such as the ureter, as well as the involvement of the nerve structures of the pelvic plexus in the suture.

The closest to the proposed method is (RU, patent 2235517, published 10.09.2004) a method that includes correction of prolapse and partial prolapse of the internal genital organs in women by incision and separation of the anterior vaginal wall with exposure of the lateral walls of the cervix and cardinal ligaments on both sides, formation of paraurethral canals behind the pubis so that the angle between the direction of the canal and the symphysis is 30-40° on each side, passing ligatures made of non-absorbable material through the formed canals, removing and fixing the middle of the ligatures above the aponeurosis of the external oblique abdominal muscles in the suprapubic region on each side, leaving the free ends of the ligatures in the vaginal wound on both sides, alternately suturing the cardinal ligaments from the side of the vaginal wound with one of the free ends of the ligatures, pulling and tying the ends of each ligatures between themselves under visual control, suspending the uterus by the aponeurosis with subsequent restoration of the anterior wall of the vagina.

The disadvantages of this method are the lack of a developed surface of thin ligatures and low fixation ability in the tissues through which they pass, they must be tied and fixed behind the aponeurosis, this creates additional stress on the organs. In addition, the small thickness of the threads when they are stretched and during physical exertion of the patient can lead to the concentration of local stress on the tissue and worsen the healing of the wound surface and a relapse of prolapse may develop.

The technical task that the developed method is aimed at solving is to restore the anatomy of the pelvic floor, adequate urination and sexual life, as well as improve the quality of life of women in general.

The technical result achieved by implementing the developed method consists in increasing the effectiveness of treatment while simultaneously reducing its trauma. The reduction in trauma is achieved by the fact that the developed method using a polypropylene prosthesis allows for a decrease in the area inside the pelvic dissection and a significant reduction in the volume and weight of the mesh implant. To achieve the specified technical result, it is proposed to use the developed method for treating isolated hysteroptosis.

To achieve the specified technical result, it is proposed to use the developed method for treating isolated hysteroptosis using a mesh polypropylene implant. When implementing the developed method, a longitudinal incision is made in the posterior wall of the vagina and the underlying fascia, starting from the posterior fornix, 25-30 mm long, pararectal translatory canals are formed with the index finger to the sciatic spines on both sides, the anterior surface of the sacrospinal ligaments is exposed; the rectum and pararectal tissue are displaced medially, using a transsacrospinal trocar, on the principle from the inside out, a puncture of the sacrospinal ligament is performed in the area of its inner third in the middle of its width, and then along the trocar - the sacrotuberous ligament, gluteal muscles, subcutaneous fat and skin of the gluteal region, during the puncture of the sacrospinal ligament, the index finger located between the trocar and the lateral wall of the rectum is insured against damage to the latter, a provisional guide thread is passed through the puncture, the trocar is removed, a similar manipulation is performed on the opposite side, a transverse incision is made in the anterior wall of the vagina at the level of the isthmus of the uterus, with the use of. a provisional guide thread is passed through the anterior transobturator trocar on both sides around the cervix, then the prosthesis is fixed to the threads and passed around the cervix, the middle part of the mesh prosthesis is fixed to the anterior surface of the cervix for 3 cm with a non-absorbable continuous Etibond (1-0) suture, the "sleeves" of the prosthesis are passed through the sacrospinal ligaments using the in-out method onto the gluteal region under moderate tension, both vaginal incisions are sutured with 3-0 absorbable suture material, at the end of the operation the sleeves of the implant-tape are pulled up, which is accompanied by lifting and returning the uterus, the posterior wall of the vagina and its dome to their physiological anatomical positions.

In a preferred embodiment, a CYRENE tape implant is used with the following characteristics: length - 20 cm, width - 4.5 cm, thread diameter - 0.15 mm, cell diameter - 0.50 mm, average weight - 70 g/ ^cm2 , proportion of lumens in the total area - 85%, tensile strength of 55 N (Newton), extensibility of 57.3, material of manufacture - bioinert polypropylene.

The method allows to reduce the risk of damage to tissues and organs of the small pelvis during surgery, intraoperative complications, reduces technical difficulties in eliminating anatomical defects of the pelvic floor, allows to achieve good functional results. The technique allows to achieve the return of the uterus to its original anatomical points and to preserve the uterus even in case of its prolapse (4th degree hysteroptosis).

Below are specific examples of the implementation of the claimed method for treating isolated hysteroptosis.

Below are specific examples of the implementation of the claimed method for treating isolated hysteroptosis.

1) Patient E., 54 years old.

Admitted to the Urology Clinic of the First Moscow State Medical University named after I.M. Sechenov with the diagnosis: urogenital prolapse stage III according to POP - Q: hysteroptosis stage III.

Complaints of a sensation of a foreign body in the vagina

Medical history

Over the past 6 months, she began to notice the above complaints. She was consulted at LDO No. 4 of the Clinical Hospital No. 2. During the examination, hysteroptosis was detected. She was hospitalized on a planned basis for surgical treatment.

Obstetric and gynecological history: pregnancies - 4, births - 2 (term, spontaneous, without peculiarities). Menopause since 48 years.

Local status. The lumbar region is visually unchanged. The symptom of tapping on the lumbar region is negative on both sides. The kidneys are not palpated. The urinary bladder is not determined by palpation and percussion. The external genitalia are formed correctly. Urination is frequent, painless, not difficult, urine is visually unchanged.

Vaginal examination: the external genitalia are developed correctly. The anterior vaginal wall is sound, not prolapsed. The cervix is not elongated, not eroded, cylindrical, not deformed, and protrudes beyond the limits by 3 cm (C+3) when straining. The body of the uterus is tilted forward, not enlarged, mobile, and painless when palpated and displaced. The posterior wall is not prolapsed. The appendages on both sides are not palpated, their area is painless.

Survey data:

PISQ 12: no sexual life (due to prolapse)

PFDI-20: 120 points

PFIQ-7: 134 points

Diagnostic examination data

Ultrasound of the pelvic organs: uterus, ovaries, cervix - without features, free fluid in the pelvis - not determined. Volumetric pathology of the pelvis was not revealed.

Ultrasound of the kidneys and bladder: the right kidney measures 10.0 x 5.0 cm, with clear, even contours, the parenchyma is homogeneous, up to 2.0 cm thick. No dilation of the renal pelvis and calyces was detected. Kidney mobility is within normal limits. The left kidney measures 10.0 x 5.0 cm, with clear, even contours, the parenchyma is homogeneous, up to 1.9 cm thick. No dilation of the renal pelvis and calyces was detected. Kidney mobility is within normal limits. The urinary bladder has clear, even contours, and a volume of 291 ml. Wall thickness is 3 mm. Residual urine volume is 15 ml.

Uroflowmetry: maximum flow rate - 14.0 ml/sec, average flow rate - 8.6 ml/sec, emptying volume - 250 ml.

In order to correct the prolapse, the patient underwent surgical treatment using our method with a polypropylene implant.

Progress of the operation:

The duration of the operation is 1 hour 12 minutes.

Blood loss - 50 ml.

The vaginal tampon and urethral catheter were removed on the 1st day after the operation.

Ultrasound: no residual urine. The renal pelvis is not dilated on either side.

The patient was discharged on the 3rd day.

At examination 1 month after surgery:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 6.5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: 48 points

PFDI - 20: 0 points

PFIQ - 7: 0 points

Ultrasound: no residual urine. The renal pelvis is not dilated on either side.

Uroflowmetry: maximum flow rate - 18.0 ml/sec, average flow rate - 11.7 ml/sec, residual urine - 18 ml.

At the 6 month follow-up:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 6.5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: 48 points

PFDI - 20: 0 points

PFIQ - 7: 0 points

At the 1 year follow-up:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 6.5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: 48 points

PFDI - 20: 0 points

PFIQ - 7: 0 points

2) Patient B., 75 years old

Admitted to the Urology Clinic of the First Moscow State Medical University named after I.M. Sechenov with the diagnosis: urogenital prolapse stage III according to POP - Q: hysteroptosis stage III.

Complaints of a sensation of a foreign body in the vagina, frequent urination in small portions

Medical history

Over the past 6 years, she began to notice the above complaints. She was consulted at LDO No. 4 of the Clinical Hospital No. 2. During the examination, hysteroptosis was detected. She was hospitalized on a planned basis for surgical treatment.

Obstetric and gynecological history: pregnancies - 1, births - 1 (term, spontaneous, without peculiarities). Menopause since 50 years.

Local status. The lumbar region is visually unchanged. The symptom of tapping on the lumbar region is negative on both sides. The kidneys are not palpated. The urinary bladder is not determined by palpation and percussion. The external genitalia are formed correctly. Urination is frequent, painless, not difficult, urine is visually unchanged.

Vaginal examination: the external genitalia are developed correctly. The anterior vaginal wall is sound, not prolapsed. The cervix is not elongated, not eroded, cylindrical, not deformed, and protrudes beyond the limits by 1.5 cm (C+1.5) when straining. The body of the uterus is tilted forward, not enlarged, mobile, and painless when palpated and displaced. The posterior wall is not prolapsed. The appendages on both sides are not palpated, their area is painless.

Survey data:

PISQ 12: No sex life

PFDI - 20: 125 points

PFIQ - 7: 132 points

Diagnostic examination data

Ultrasound of the pelvic organs: uterus, ovaries, cervix - without features, free fluid in the pelvis - not determined. Volumetric pathology of the pelvis was not revealed.

Ultrasound of the kidneys and bladder: the right kidney measures 10.0 x 5.5 cm, with clear, even contours, the parenchyma is homogeneous, up to 1.8 cm thick. No dilation of the renal pelvis and calyces was detected. Kidney mobility is within normal limits. The left kidney measures 10.0 x 5.0 cm, with clear, even contours, the parenchyma is homogeneous, up to 1.7 cm thick. No dilation of the renal pelvis and calyces was detected. Kidney mobility is within normal limits. The urinary bladder has clear, even contours, and a volume of 254 ml. Wall thickness is 3 mm. Residual urine volume is 15 ml.

Uroflowmetry: maximum flow rate - 15.9 ml/sec, average flow rate - 10.6 ml/sec, emptying volume - 254 ml.

In order to correct the prolapse, the patient underwent surgical treatment using our method with a polypropylene implant.

Progress of the operation:

Duration of the operation is 1 hour 05 minutes.

Blood loss - 20 ml.

The vaginal tampon and urethral catheter were removed on the 1st day after the operation.

Ultrasound: no residual urine. The renal pelvis is not dilated on either side.

The patient was discharged on the 3rd day.

At examination 1 month after surgery:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: No sex life

PFDI - 20: 0 points

PFIQ - 7: 0 points

Ultrasound: no residual urine. The renal pelvis is not dilated on either side.

Uroflowmetry: maximum flow rate - 18.4 ml/sec, average flow rate - 11.2 ml/sec, residual urine - 18 ml.

At the 6 month follow-up:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: No sex life

PFDI - 20: 0 points

PFIQ - 7:0 points

At the 1 year follow-up:

The patient has no complaints. Vaginal examination reveals normal external genitalia, no prolapse of the vaginal walls is observed during cough test and straining. Scars on the vaginal walls and perineum are normal. The cervix is not deformed, is determined to be 5 cm above the hymen. The body of the uterus is tilted forward, not enlarged, mobile, painless on palpation. The appendages on both sides are not palpated, their areas are painless. No pain is observed on palpation. Ultrasound examination of the pelvis and perineum is normal.

Survey data:

PISQ 12: No sex life

PFDI - 20: 0 points

PFIQ - 7: 0 points

Claims (2)

1. A method for treating hysteroptosis using a mesh polypropylene implant, characterized in that a longitudinal incision is made in the posterior wall of the vagina and the underlying fascia, starting from the posterior fornix, 25-30 mm long, pararectal translatory canals are formed with the index finger to the sciatic spines on both sides, the anterior surface of the sacrospinal ligaments is exposed; the rectum and pararectal tissue are displaced medially, using a transsacrospinal trocar, according to the principle from the inside out, a puncture of the sacrospinal ligament is made in the area of its inner third in the middle of its width, and then along the trocar - the sacrotuberous ligament, gluteal muscles, subcutaneous fat and skin of the gluteal region, during the puncture of the sacrospinal ligament, the index finger located between the trocar and the lateral wall of the rectum is used to insure the latter from damage, a provisional guide thread is passed through the puncture, the trocar is removed, a similar manipulation is performed on the opposite side, a transverse incision is made in the anterior wall of the vagina at the level of the isthmus of the uterus, using the anterior transobturator trocar, a provisional guide thread is passed on both sides around the cervix, then, having fixed the prosthesis to the threads, it is passed around the cervix, the middle part of the mesh prosthesis is fixed to the anterior surface cervix for 3 cm with non-absorbable continuous Etibond 1-0 suture, the "sleeves" of the prosthesis are passed through the sacrospinal ligaments using the in-out method onto the gluteal region in a state of tension, both vaginal incisions are sutured with absorbable suture material 3-0, at the end of the operation the sleeves of the implant-tape are pulled up with simultaneous lifting and return to their physiological anatomical positions of the uterus, the posterior wall of the vagina and its dome. 2. The method according to item 1, characterized in that it uses a CYRENE tape implant with the following characteristics: length - 20 cm, width - 4.5 cm, thread diameter - 0.15 mm, cell diameter - 0.50 mm, average weight - 70 g/ ^cm2 , proportion of lumens in the total area - 85%, tensile strength of 55 N, extensibility of 57.3, material of manufacture - bioinert polypropylene.