子宫切除术后盆腔器官脱垂手术矫正方法的比较分析

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INTRODUCTION

Genital prolapse occurs in 67% of females after hysterectomy [1]. The incidence of post-hysterectomy prolapse requiring surgery is estimated to be 36 per 10,000 women [2]. Indications for surgery include symptoms associated with pelvic organ prolapse after hysterectomy prolapse [3], such as pelvic pressure, foreign body sensation inside and outside the vagina, back pain, and bladder, bowel, and sexual issues [4]. These symptoms have a significant impact on women’s quality of life after hysterectomy, leading not only to physical and emotional distress, but also to partial or complete disability [5].

The literature shows that 12% of women undergoing hysterectomy had surgery for pelvic organ prolapse [6].

There are abdominal, laparoscopic, and vaginal surgical procedures for post-hysterectomy prolapse using autologous, alloplastic, and synthetic materials [7]. The most common surgical treatment options for post-hysterectomy prolapse include laparoscopic sacral vaginopexy [8] and sacrospinous fixation [9], including apical sling with an UroSling-1 mesh endoprosthesis [10]. In some studies, laparoscopic sacral vaginopexy is considered the optimal treatment for vaginal vault prolapse [11] and is associated with a high success rate and low recurrence rate due to the supportive role of vaginal mesh [12]. However, this procedure can be complicated by an extended operation time and hospital stay [13]. Some authors consider sacrospinous fixation to be the preferred option because this technique is free of risks associated with intraperitoneal manipulation and ensures a shorter duration of surgery [14]. A significant issue with this type of treatment is buttock pain and dyspareunia, which may be caused by irritation of the nerve structures adjacent to the sacrospinous ligament, excessive tension of the sutures, and displacement of the vagina toward fixation [15]. There are conflicting results and recommendations for the use of these surgical procedures. Each of these surgical techniques has a number of limitations that prevent its use as a one-size-fits-all option [16], requiring search for new approaches to the treatment of post-hysterectomy prolapse [17].

AIM

The aim of the study was to compare outcomes of laparoscopic sacral vaginopexy, sacrospinous fixation, and the proposed new surgical technique in treatment of post-hysterectomy prolapse after subtotal hysterectomy.

MATERIALS AND METHODS

The prospective, non-randomized study included 57 patients with post-hysterectomy prolapse who presented to the RZD-Medicine Clinical Hospital (Tula, Russia) from August 2019 to September 2023. All patients provided signed informed consent to participate in the study. The study was approved by the Ethics Committee of the Medical Institute of the Tula State University (Protocol No. 2 of 15 February 2021).

The study group was formed using continuous topic sampling.

Eligibility Criteria included history of subtotal hysterectomy for benign neoplasm; stage II, III, IV symptomatic pelvic organ prolapse after hysterectomy; consent for propylene implant placement.

Exclusion criteria included cancer, hysterectomy for other indications, cervical and vaginal disease, severe medical conditions contraindicating surgery, and massive pelvic adhesions.

All patients were divided into three groups. The first (main) group (n = 18) included women who received surgical treatment of post-hysterectomy prolapse using a new two-step surgical technique [18], and the first stage included anterior and posterior subfascial colporrhaphy in 94.4% of cases (n = 17). The second group (n = 19) included women who underwent laparoscopic sacrocolpopexy using the classical technique [19]. The third group (n = 20) included women who underwent apical sling according to the published technique [20] using the UroSling-1 mesh endoprosthesis (Lintex LLC, St. Petersburg, Russia). In 95% (n = 19) of the cases, both the anterior and posterior parts of the pelvic floor were treated.

The study included gynecologists who had previously performed at least 20 study procedures, excluding procedures using the new technique. The surgical technique was chosen by a surgeon and discussed with a patient.

Patients were evaluated according to the standard of care for pelvic prolapse.

Complaints and medical history were assessed and a physical examination was performed. The scope of previous hysterectomy was considered. The quality of life of patients was assessed. The gynecologic examination included assessment of the vaginal mucosa, the degree of anterior and posterior vaginal wall prolapses at rest and on exertion, the status and degree of cervical prolapse, if present, and cough stress test and straining test. Digital rectal examination was performed to detect rectocele or enterocele.

Standard laboratory tests, smear tests, and cytology were performed. All patients underwent pelvic ultrasound and, if dysuria was present, urinary tract and renal ultrasound and uroflowmetry were performed, and residual urine volume was determined. Patients with urinary tract symptoms were referred to a urologist.

The Pelvic Organ Prolapse Quantification System (POP-Q) was used to determine the severity of prolapse after hysterectomy.

The Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7) were used to assess quality of life. Patients were asked to complete questionnaires before and at 12 and 24 months after surgical treatment of post-hysterectomy prolapse. Patients were asked to return for follow-up visits at 1, 6, 12, and 24 months.

Statistical analysis was performed using StatTech v. 2.8.8 (StatTech LLC, Russia). Quantitative parameters were tested for normality of distribution using the Shapiro-Wilk test or the Kolmogorov–Smirnov test. Quantitative parameters with a normal distribution were presented as arithmetic means (M) and standard deviations (SD) with 95% confidence intervals (95% CI), and categorical data were presented as absolute values and percentages. Three groups were compared for quantitative parameters with normal distribution using one-way analysis of variance, with post hoc comparisons using Tukey’s test. One-way repeated measures analysis of variance was used to compare three groups for a normally distributed quantitative parameter. Statistical significance of parameter changes over time was assessed using Pillai’s trace, and post hoc analysis was performed using paired Student’s t-test with Holm correction.

Surgical technique

The first step of the surgery was performed through a vaginal access. A patient was placed in the lithotomy position. A 14–16 Fr Foley urethral catheter with an inflatable cuff and urine collector was placed. After aquadissection of the anterior vaginal wall with 0.9% saline, an incision was made in the most prolapsed part of the vaginal wall down to the subfascial space of 4–5 cm. The edges of the vaginal mucosa were grasped using Allis clamps. Subfascial dissection of the paravaginal tissues was performed using a blunt technique toward the pelvic peritoneum, exposing as much of the cervix as possible and isolating the vaginal walls laterally to the pelvic peritoneum. A 15 mm wide and 120–140 mm long endoprosthetic band was cut from a polypropylene mesh. At one end of the tape, a loop approximately 20 mm in diameter was sewn with Prolene thread. The tape was secured along the cervix with 3 to 5 interrupted sutures using non-absorbable Bioinert thread, and the free end with a loop was placed directly on the peritoneum after being rolled into a cuff. Subfascial colporrhaphy was then performed using a non-absorbable Bioinert thread with a Halsted suture, capturing a fixed portion of the mesh in the suture. If a rectocele was present, a posterior subfascial colporrhaphy was performed (Figure 1).

Fig. 1. Vaginal stage of fixation of the endoprosthesis.

After the vaginal step of surgery was completed, the second, laparoscopical, step was performed. First, a classical laparoscopic abdominal access was formed. The peritoneum was opened above the cervical stump and an endoprosthesis tape was inserted into the abdomen. The peritoneum above the promontorium was opened. Tissue was dissected under the peritoneum with an endoscopic flexible blunt-ended dissector down to the cervical stump involving the polypropylene endoprosthesis tape loop. The tape was passed under the peritoneum and secured to the anterior longitudinal ligament of the spine with a non-absorbable suture. The loop was cut off. Peritoneal defects were sutured with absorbable sutures (Figure 2).

Fig. 2. Stage of the peritoneal endoprosthesis to the promontory.

FINDINGS

Before surgery, all patients complained of discomfort, a foreign body sensation in the vagina, which increased after exercise and at the end of the day. Patients reported pulling pain in the lower abdomen after exercise in 12 (21.1%) cases. Urinary difficulty was reported by 47 (82.5%) patients, constipation by 22 (38.4%), and dyspareunia by 28 (49.1%). Stress urinary incontinence was diagnosed in 4 (7.0%) cases. Table 1 shows the clinical characteristics of the group.

Table 1. General clinical characteristics of patient groups

Note. BMI, body mass index; р, level of statistical significance; n, quantity; М, median value; SD, standard deviation, POP-Q, Pelvic Organ Prolapse Quantification; Аа and Ва, distal and proximal parts of the anterior vaginal wall; Ар and Вр, distal and proximal parts of the posterior vaginal wall; C, distal edge of the cervix.

No statistically significant differences were found between three groups according to the data presented.

In group 1, the above surgical technique was used. In group 2, a laparoscopic sacral vaginopexy was performed. In group 3, a sacrospinous fixation with the UroSling-1 mesh endoprosthesis was performed. Table 2 shows the characteristics of surgical treatment.

Table 2. Characteristics of surgical treatment

Note. * The differences are statistically significant (p < 0,05); p^1–2–3, comparison of three groups: first, second, and third; p^1–2, comparison of the first and second groups; p^1–3, comparison of the first and third; p^2–3, comparison of the second and third; n, quantity; М, median value; SD, standard deviation.

The data obtained showed that surgery duration in group 2 was statistically significantly longer than in groups 2 and 3. Blood loss in group 2 was statistically significantly less than in groups 2 and 3, but blood loss did not exceed 50 mL in all groups.

No intraoperative or postoperative complications were reported in any group. The mean length of hospital stay was 4.4 ± 0.6 (95% CI: 4.1, 4.7) bed-days in group 1, 4.9 ± 1.1 (95% CI: 4.6, 5.3) in group 2, 4.6 ± 0.6 (95% CI: 4.3, 4.9) in group 3; differences were not significant (p^1–2 = 0.437, p^1–3 = 0.137, p^2–3 = 0.235).

Simultaneous TVT-O sling surgery for stress urinary incontinence due to severe symptoms was performed in 2 patients (11.1%) in group 1, 1 patient (5.2%) in group 2, and 1 patient (5.0%) in group 3.

In group 1, one patient developed symptoms of stress urinary incontinence 1 month after surgery; TVT-O sling surgery was performed 3 months later with a positive outcome. No vaginal mucosal erosion or mesh extrusion occurred in any group.

Analysis of POP-Q scores in three groups showed statistically significant improvement at 12 and 24 months after surgery. However, the anatomical evaluation at 24 months showed statistically significant differences at points Aa and Ba (for point Аа: p^1–3 = 0.007, p^2–3 = 0.004 (Figure 3); for point Ва: p^1–3 = 0.032, p^2–3 = 0.041 (Figure 4)).

Fig. 3. Dynamics of the Aa indicator after 12 and 24 months.

Fig. 4. Dynamics of the Ba indicator after 12 and 24 months.

Comparison of questionnaire scores before surgery and at 12 and 24 months after surgery showed a significant improvement in the patients’ quality of life in three groups. No statistically significant differences between groups were found according to FIQ-7 scores (Figure 5) and PEDI-20 scores (Figure 6).

Fig. 5. Dynamics of PFIQ-7 indicators depending on the type of surgical intervention.

Fig. 6. Dynamics of PFDI-20 indicators depending on the type of surgical intervention.

DISCUSSION

Our study showed that symptoms of post-hysterectomy prolapse were significantly reduced in all three groups. A study by Köleli et al. [14] showed that operative time and hospital stay were shorter in the sacrospinous fixation group compared to the laparoscopic sacral vaginopexy group. Our results showed no statistically significant differences in the length of hospital stay between three groups, which was consistent with the mean length of stay in the study by Bastani et al. [12], where patients were admitted the day before surgery and discharged after 4 days. Bastani et al. [16] showed that the blood loss rate in sacrospinous fixation was higher than that in laparoscopic sacral vaginopexy which is associated with tissue dissection in the actively perfused area for sacrospinous fixation. Our study confirms these data. However, Köleli et al. [14] and Marcickiewicz et al. [21] showed similar intraoperative blood loss with laparoscopic sacral vaginopexy and sacrospinous fixation. Intraoperative blood loss rates in treatment of post-hysterectomy prolapse with the new surgical technique were similar to that in sacrospinous fixation.

Baghdadi et al. [22] showed that laparoscopic sacral vaginopexy was more effective in the treatment of post-hysterectomy prolapse, especially in advanced stages. The recurrence rate of post-hysterectomy prolapse was lower after laparoscopic sacral vaginopexy than after sacrospinous fixation. However, retrospective studies by Köleli et al. [14] and Marcickiewicz et al. [21] showed the same anatomical outcomes of both techniques, which was not confirmed by our data. Our study showed comparable anatomical outcomes 12 months after laparoscopic sacral vaginopexy, sacrospinous fixation, and the new proposed technique at all points, but statistically significant differences were obtained at 24 months: status at points Aa and Ba after sacrospinous fixation was worse than after laparoscopic sacral vaginopexy and surgery with our new technique.

The present study showed that preoperative PFDI-20 and PFIQ-7 scores were similar in three groups. In three groups, PFDI-20 and PFIQ-7 scores decreased significantly at 12 and 24 months after surgery compared to preoperative scores. Overall, three types of surgery reduced the major symptoms of post-hysterectomy prolapse during the follow-up period, although no statistically significant difference was observed.

CONCLUSION

Post-hysterectomy prolapse is a difficult-to-treat condition that often requires surgery due to severity of symptoms and failure of non-surgical treatment. The proposed technique provides high anatomic and functional outcomes, allows visual guidance through all steps of the procedure compared to sacrospinous fixation, reduces operative time compared to laparoscopic sacral vaginopexy, and also reduces the likelihood of repeat surgery due to recurrence. Surgeons performing procedures for post-hysterectomy prolapse should evaluate the patient’s condition, stage of prolapse, and their own experience to achieve a satisfactory outcome.

ADDITIONAL INFO

Authors’ contribution. V.G. Volkov, O.V. Soloveva — the concept and design of the study; O.V. Soloveva, K.Yu. Sorokoletov — collection and processing of the material; O.V. Soloveva — statistical data processing; O.V. Soloveva — writing a text; V.G. Volkov — editing. All authors confirm that their authorship meets the international ICMJE criteria (all authors made a substantial contribution to the conception of the work, acquisition, analysis, interpretation of data for the work, drafting and revising the work, final approval of the version to be published and agree to be accountable for all aspects of the work).

Funding source. The work was carried out according to the research plan of the Tula State University, state registration No. 115102710029, subject code 49-16.

Competing interests. The authors declares that there are no obvious and potential conflicts of interest associated with the publication of this article.

Consent for publication. The patients who participated in the study signed an informed consent to participate in the study and publish medical data.

作者简介

Olga V. Soloveva

编辑信件的主要联系方式.
Email: okudryavceva@yandex.ru
ORCID iD: 0000-0003-1671-5265
Scopus 作者 ID: 57953098600
Researcher ID: KHY-6625-2024
俄罗斯联邦, Tula; Tula

Valery G. Volkov

Email: valvol@yandex.ru
ORCID iD: 0000-0002-7274-3837
SPIN 代码: 7336-0574
Scopus 作者 ID: 7402984134
Researcher ID: D-3547-2016

MD, Dr. Sci. (Medicine), Professor

Kirill Y. Sorokoletov

Email: Doktor-sky@yandex.ru
ORCID iD: 0009-0005-3595-5573
俄罗斯联邦, Tula

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1. JATS XML

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2. Fig. 1. Vaginal stage of fixation of the endoprosthesis.

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3. Fig. 2. Stage of the peritoneal endoprosthesis to the promontory.

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4. Fig. 3. Dynamics of the Aa indicator after 12 and 24 months.

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5. Fig. 4. Dynamics of the Ba indicator after 12 and 24 months.

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6. Fig. 5. Dynamics of PFIQ-7 indicators depending on the type of surgical intervention.

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7. Fig. 6. Dynamics of PFDI-20 indicators depending on the type of surgical intervention.

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