RU2499570C2 - Method of surgical treatment of anterior vaginal wall prolapse in women with high risk of relapse after extirpation of uterus - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to operative gynecology and can be applied in treatment of women with anterior vaginal wall prolapse with high risk of relapse after extirpation of uterus. For this purpose transvaginal access is realised. Longitudinal cut of vagina mucous membrane, with 2.5-3 cm indent proximally from external urethra orifice is performed. Not only vagina mucous membrane but also underlying fascia is dissected to reduce risk of erosion development in post-operative period. After that, reconstruction of anterior and apical parts of pelvic floor is carried out. For this purpose four branches of front part of mesh implant are passed by means of guides through obturator membrane along tendinous arch of pelvic fascia on skin of perineum, two branches from each side. Two branches of posterior part of mesh implant are passed through medial parts of sacrospinal ligaments on skin of perineum laterally and lower than anus by means of guides. Isthmus between anterior and posterior parts of mesh implant is fixed by its edges in its medium part to sacrouterine ligaments from two sides by nonabsorbable threads. Implant straightened in sagittal projection has form of "poker", and its short posterior part faces rectum. After straightening of front and back parts of implant and its isthmus fixation, free ends of branches of posterior part of implant are cut off subcutaneously, and branches of anterior part are sutured subcutaneously to each other without tension with non-absorbable sutures. Excess is cut off and submerged into tissues. Vaginal wall is sutured with uninterrupted absorbable sutures, skin cuts are sutured with interrupted sutures in the area of perineum.

EFFECT: method makes it possible to ensure creation of neo-fascia instead of destroyed one due to definite method of laying and fixing mesh implant as a result of selection of the strongest structures of small pelvis for its fixation, which prevents possible following protrusion of vagina walls in case of intra-abdominal pressure increase, as well as due to application of mesh implant made lighter due to definite structure.

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Description

The invention relates to gynecology, in particular, to operative gynecology.

In Russia, prolapse of the pelvic organs to one degree or another occurs in every 10th woman, and in the group of the late reproductive age - in every 3rd.

Today, there are more than a hundred methods for the surgical treatment of pelvic organ prolapse. These are various methods of vaginal, transabdominal, laparoscopic and robotic surgery, which are successfully performed in our country. However, any surgical treatment for prolapse is associated with a high relapse rate.

Many surgical methods for treating pelvic organ prolapse did not meet expectations, accompanied, despite its diversity, by a high risk of relapse - from 33 to 58% [12].

The prerequisite for the development of prolapse and an increase in the number of relapses are often undifferentiated forms of connective tissue dysplasia, in which the use of methods using their own obviously failed tissues is doomed to failure, which justifies the wider use of implants. Of the proposed biological and synthetic prostheses, synthetic materials are currently preferred due to fewer complications and higher efficacy [7, 11]. There are more than a dozen methods for surgical reconstruction of the pelvic floor using synthetic prostheses.

The modern concept of surgical treatment of genital prolapse should consist of "replacing" the old destroyed pelvic fascia with a new one, with its fixation to the anatomically strong structures of the small pelvis.

The concept of “replacement” surgery is advanced and is reflected in the introduction of new techniques. The transvaginal technology of conducting a synthetic free implant without tension (tension free vaginal mesh) using conductors quickly meets this goal.

According to a systematic review and meta-analysis of randomized trials with the use of mesh technologies in the surgical treatment of genital prolapse, an increase in efficiency of up to 75% -92% is noted [9]. Relapses using synthetic materials in the reconstruction of the pelvic floor vary from 5.2 to 8.3% [2]. The difference with the results without the use of synthetic materials is obvious.

However, today there is still no consensus on the use of mesh implants in pelvic surgery. Opponents of the use of implants are based on a small number of randomized trials and an increase in the frequency of complications associated with foreign material: erosion, dyspareunia, infectious complications, mesh protrusion [6].

Controversial and debatable aspects of the use of mesh materials are specific complications associated with the presence of foreign material.

According to the results of various researchers, the frequency of erosion during colporography with the installation of synthetic materials can reach 15-30% [13]. However, the likelihood of this complication is sharply reduced to 0.5–5% [5] when observing the recommendations for the use of type I nets based on the classification of P.K. Amid (1997).

The requirements for an “ideal implant” are also complemented by high elasticity, strength, low wick ability, biological compatibility, versatility and accessibility of the application technique, and economic feasibility.

We are supporters of the use of mesh-technologies in young women, as one of the most significant causes of genital prolapse and their relapses, researchers consider signs of "weakness" of connective tissue detected more often in "young" women [3]. This fact is a good reason for the use in women with failed connective tissue, according to the general principles of herniology, additional strengthening materials that can initiate the body's reaction in the form of fibrosis and the formation of dense connective tissue [8].

This is especially true for women with obviously insolvent connective tissue, usually of reproductive age, with a characteristic “aggressive” course of the disease with the formation of combined forms of prolapse and prolapse of the internal genital organs (Shalaev O.N., 2008).

The prototype of the method we developed for the surgical treatment of pelvic organ prolapse using synthetic material was the transvaginal synthetic implant without tension using conductors (Transvaginal Mesh Procedures for Pelvic Organ Prolapse, No. 254, February 2011, 1102E.pdf).

There are many common techniques for transvaginal mesh implant, but we consider it necessary to further improve these techniques.

According to our observations, the tendon arch of the pelvic fascia was absent or poorly expressed in 33.4% of women, and according to the literature, in 50-70% of women (4). This may increase the risk of recurrence of prolapse of the anterior vaginal wall.

The lack of fixation of the isthmus of the mesh implant during hysterectomy is a risk factor for the development of enterocele and apical prolapse in the postoperative period.

We have proposed a new method for surgical treatment of genital prolapse using a mesh implant established by transvaginal access.

Today on the medical market there are many synthetic implants for surgical reconstruction of the pelvic floor.

However, we use an implant made of a non-absorbable mesh cut in a single block, made of a material with polypropylene monofilaments with a diameter of not more than 0.07 mm, surface porosity of less than 40 g / m ² and volume porosity of 98.

These grid parameters create a unique structure, which, in turn, helps to increase its flexibility. A lightweight endoprosthesis for reconstructive surgery of the pelvic floor has exceptional softness and high bulk porosity. Due to the combination of high bioinertness indicators and special structural and mechanical properties, the mesh ensures the formation of a thin, delicate and uniform scar in the implantation zone. The endoprosthesis is highly resistant to infection. The mesh has excellent strength, durability and surgical adaptability and has a suitable porous structure, which is necessary for more efficient germination of collagen.

The use of additional support points when fixing the mesh implant allows you to use a lighter mesh, which, accordingly, reduces the number of complications, such as erosion, incomplete healing of the vaginal mucosa, dyspareunia, etc.

As a device to facilitate the conduct of a synthetic implant and fix it to reliable structures of the pelvic floor, reusable conductors can be used.

The technical result of this invention is the effective treatment of patients with a high risk of recurrence of prolapse of the anterior vaginal wall with the formation of cystocele by creating neofascia instead of destroyed, which is ensured by a certain method of distribution and fixation of the mesh implant due to the choice of the most durable structures of the small pelvis for its fixation, which prevents possible subsequent protrusion of the walls of the vagina with an increase in intra-abdominal pressure, as well as due to the use of lightweight, due to the specific structure of the mesh implant itself.

The method is as follows.

The operation is usually performed under regional spinal or epidural anesthesia (other methods of analgesia may be used). The patient is placed on the operating table in a lithotomy position. The surgical field is treated with antiseptic solutions, then the bladder is emptied.

Carry out transvaginal access. A longitudinal incision is made of the vaginal mucosa, retreating 2.5-3 cm proximal to the external opening of the urethra. It is necessary to dissect not only the vaginal mucosa, but also the underlying fascia to reduce the risk of erosion in the postoperative period.

Then, the anterior and apical pelvic floor are reconstructed. For this, four sleeves of the front part of the mesh implant are guided through conductors through the locking membrane along the tendon arch of the pelvic fascia onto the perineal skin, two sleeves on each side. Two sleeves of the posterior part of the mesh implant by means of conductors are passed through the medial sections of the sacro-spinous ligaments to the perineal skin laterally and below the anus. The isthmus between the anterior and posterior parts of the mesh implant is fixed over its edges in its middle part to the sacro-uterine ligaments on both sides using non-absorbable sutures. Distributed in this way the implant in the sagittal projection has the form of a "poker" (figure 1). At the same time, its short back is directed toward the rectum. After straightening the front and rear parts of the implant and fixing the isthmus, the free ends of the sleeves of the back of the implant are cut subcutaneously, and the sleeves of the front part are sutured subcutaneously to each other without tension with non-absorbable threads (Fig. 2). Suturing the front sleeve of the implant with each subcutaneously above the obstructive membrane creates additional strengthening of the structure and preventing the recurrence of the anterior vaginal wall.

The excess is cut and immersed in tissue. The vaginal wall is sutured with a continuous absorbable suture, cuts of the skin in the perineal region are sutured with separate sutures.

The bladder is catheterized, tight tamponade of the vagina is performed with sterile wipes with antibacterial ointments. After 24 hours, the catheter and tampon are removed.

According to the proposed methodology, 112 patients were operated on. The follow-up period was 3.7 years. During this time, one case of an asymptomatic course of recurrence of the anterior vaginal wall was noted (stage I according to POP-Q).

Erosion, incomplete healing in the early and late postoperative period was not noted.

The results of using a mesh implant in the surgical treatment of genital prolapse have shown their high efficiency as neofasciogenesis technologies in women with a high risk of relapse.

Example 1

B-naya Nabilkova N.N., 60 years old. Postmenopause.

Somatic diseases: osteochondrosis, flat feet, varicose veins of the lower extremities, FCB, ZhKB

Gynecological diseases: uterine fibroids

A history of supravaginal amputation of the uterus, adnexectomy on the left due to uterine fibroids, endometrioid cysts of the left ovary.

B-2 P-1 A-1

The prolapse of the walls of the vagina for 7-8 years.

Complaints of urinary retention, a feeling of a foreign body in the vagina.

Diagnosis: The prolapse of the anterior wall of the 3rd degree with the formation of a cystocele of the 3rd degree, the omission of the apical department of the 2nd degree, the posterior section of the 1st degree. Rectocele 0 degree. Cervicosis Stress urinary incontinence.

03/11/2010 vaginal extirpation of the cervical stump. Reconstruction of the anterior and apical pelvic floor with the installation of a mesh implant according to the claimed methodology. Urosling transobturator access.

POPQ after 6 months: Ba-3, BP-2, S-8

No urinary incontinence. After the operation, minor pain in the sacral region was noted for 2 weeks. Not at present. The pains stopped on their own. The patient was discharged on time.

Example 2

B-naya. Gusarova L.A., 02/14/1932

Diagnosis: Endometrial hyperplasia in postmenopausal women. Elongation of the cervix. Cervicosis Omission of the anterior wall 3 degrees, cystocele 3 degrees, posterior wall 2 degrees, apical department 3 degrees. Stress urinary incontinence.

Somatic diseases: coronary heart disease, angina pectoris, arrhythmia, chronic gastritis, chronic pain Hemorrhoids, osteochondrosis, appendectomy, cholecystectomy

Postmeonpause. B-5 P-2 A-3

Perineal rupture in childbirth 2 tbsp.

Gynecological diseases: xp / adnexitis

The history of this disease: vaginal wall prolapse of 10 years.

Complaints about the feeling of a foreign body in the vagina.

POPQ: Ba + 4 Bp0 C + 2 D-5

04/06/2009

Operation: Vaginal extirpation of the uterus with appendages. Reconstruction of the anterior and apical department using a mesh implant of the claimed method. Urethropexy transobturator access.

Blood loss: 300 ml

POPQ: Ва-3 Вр-2 С-8 The condition of the posterior wall of the vagina is improving. B-naya discharged on time.

Example 3

B-naya M.A., 72 years old

Somatic diseases: myocardial infarction, hr. hemorrhoids, hr. cystitis, osteochondrosis, herniated disc, appendectomy, hemorrhoidectomy, tubectomy, adnexectomy

Gynecological diseases: uterine fibroids

R-2 Perineal rupture 2 tbsp.

The history of this disease: prolapse of the walls of the vagina for 3 years.

Complaints about the feeling of a foreign body in the vagina, urinary incontinence, difficulty urinating with the use of "manual allowance".

History of supravaginal uterine amputation for uterine fibroids

KUDI: mixed urinary incontinence

MRI: cystocele, uterine prolapse

Ultrasound: Cystocele 3 degrees, transverse more than a paravaginal defect, rectocele 0 degrees, apex 3 degrees.

POPQ: VA + 5 VR-2 C + 2 D-4

Diagnosis: Omission of the anterior vaginal wall 3 degrees, cystocele 3 degrees, posterior wall 1 degrees, rectocele 0 degrees, apical prolapse 4 degrees, mixed urinary incontinence. Simple cervical leukoplakia.

Operation: 03/27/2010 Vaginal extirpation of the cervical stump. Reconstruction of the anterior and apical parts of the pelvic floor using a mesh implant of the claimed method, urethropexy transobturator access.

After POPQ surgery: Front 1 st, back 1 st, apex 0 st

POPQ: VA-2 VR-2 S-8

B-naya discharged on time.

Bibliography

1. Amid P.K. Classification of biomaterials and their related complication in abdominal wall surgery // Hernia. - 1997 .-- Vol. 1. - P.15-21

2. Cosson M, Caquant F, Collinet P, Rosenthal C, Clave H, Debodinance P, Garbin O, Berrocal J, Villet R, Jacquetin B. Prolift for pelvic organ prolapse surgical treatment using the TVM group technique: a retrospective study of 96 women of less than 50 years old // - International Continence Society symposium, 2005, abstracts. - Montreal. - http://www.icsoffice.org

3. Diez-Itza I, Aizpitarte I, Becerro A Risk factors for the recurrence of pelvic organ prolapse after vaginal surgery: a review at 5 years after surgery // Int Urogynecol J Pelvic Floor Dysfunct. - 2007. - Vol.1.8. - N11. - P.1317-24

4. Ersoy M; Sagsoz N; Bozkurt MC; Apaydin N; Elhan A; Tekdemir I. Important anatomical structures used in paravaginal defect repair: cadaveric study // Eur J Obstet Gynecol Reprod Biol. - 2004 .-- Vol.10. - N112 (2). - P.206-13

5. Fatton B, Amblard J, Jacquetin B. Is hysterectomy indicated during prolapsus treatment? // Ann Urol. - 2007 .-- Vol.41. - N3. - P.91-10

6. Huebner M, Hsu Y, Fenner DE. The use of graft materials in vaginal pelvic floor surgery // Int J Gynaecol Obstet. - 2006. - Vol, 92. - N3. - P.279-88

7. Kohli N., Miklos J.R // Use of Synthetic Mesh and Donor Grafts in Gynecologic Surgery // Current Women's Health Reports. 2001, 1: 53-60

8. Klinge U, Klosterhalfen B, Muller M, Schumpelick V. Foreign body reaction to meshes used for the repair of abdominal wall hernias // Eur J Surg. - 1999 .-- Vol. 165. - P.665-73.

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10. Migliari R, De Angelis M, Madeddu G, Verdacchi T. Tension-free vaginal mesh repair for anterior vaginal wall prolapse. European Urology. 2000; 38 (2): 151-155

11. Sylvia M. Botros Peter K. Sand // Cystocele and rectocele repair: More success with mesh. Surgical techniques // June 2006, Vol. 18, No.6

12. Whiteside J.L., Weber A.M., Meyn L.A., Walters M.D. // Risk factors for prolapsed reccurence after vaginal repair // Am J Obstet Gynecol. - 2004. - 191 (5): 1533-8

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Claims (1)

A method for surgical treatment of prolapse of the anterior vaginal wall in women with a high risk of recurrence after hysterectomy, including reconstruction of the pelvic floor by installing the implant with vaginal access, characterized in that the anterior and apical parts of the pelvic floor are reconstructed, using a mesh implant, which consists of an isthmus, the front part, including four sleeves for fixation, and the rear part, including two sleeves for fixation, while the implant is made of non-rass a nesting mesh cut out by a single block made of a material with polypropylene monofilaments with a diameter of not more than 0.07 mm, surface porosity of less than 40 g / m ² and volume porosity of 98; carry out a longitudinal incision of the vaginal mucosa, retreating 2.5-3 cm proximal to the external opening of the urethra, and dissect the vaginal mucosa and the underlying fascia; four sleeves of the front part of the mesh implant by means of conductors are passed through the locking membrane along the tendon arch of the pelvic fascia and two sleeves are placed on the perineal skin on each side; two sleeves of the posterior part of the mesh implant are guided through the medial sections of the sacro-spinous ligaments to the perineal skin laterally and lower than the anus; the isthmus between the anterior and posterior parts of the mesh implant is fixed over its edges in its middle part to the sacro-uterine ligaments on both sides using non-absorbable threads; the implant expanded in this way in the sagittal projection has the form of a “poker”, with its short back part facing the rectum; after the front and back parts of the implant are straightened and the isthmus is fixed, the excess of free ends of the sleeves of the back of the implant is cut subcutaneously, and the sleeves of the front part are sutured subcutaneously to each other without tension with non-absorbable threads, the excess is cut and immersed in tissue; the vaginal wall is sutured with a continuous absorbable suture, cuts of the skin in the perineal region are sutured with separate sutures.

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