Abstract
To report the procedure of an alternative modified transvaginal repair technique (V-NOTES) and their outcomes in apical vesicovaginal fistula. Between January 2020 and January 2023, gynecological procedures resulted in the diagnosis of apical VVFs in 26 patients, 17 of whom had undergone transvaginal repair of apical vesicovaginal fistula via vaginal V-NOTES. Those patients were contacted and followed up. Outcomes included operative time, blood loss, success rate, postoperative hospital stay. The average age of the patients was 45.82(36–53) yr. The mean duration between onset of fistula and repair was 7.18(3–12) mo. The mean estimated blood loss was 10.45 ± 3.23 ml, and the average operative time was 104.2 ± 12.2 min. Patients’ postoperative hospital stay was 3.34 ± 0.72 days on average. The VVF was successfully repaired in 15(88.2%) cases, and failure was observed in 2 patients. All the 2 initial failures were cured in the second repair. No major complications developed in all 17 patients. There were also no fever (> 38℃), urge incontinence or infection in incision area. Our study suggest that the transvaginal repair of apical VVF via V-NOTES is effective and safety, and offers anticipated results without obvious complications.
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Introduction
A vesicovaginal fistula (VVF) is defined as a pathological anatomical junction between the dorsal bladder wall and the anterior vagina. The pathophysiological mechanism for this abnormal anatomic connection is a necrosis of both organ walls as a result of ischemia1. VVF has remained a disaster and of public health significance, causing remarkable morbidity, and psychological and physical problems to the patient2. The incidence in the developed world is estimated between 0.3% and 2.0%3. Although VVFs are the most commonly diagnosed fistulae of the urinary tract, there is no standardized surgical technique for their treatment3.
Conservative treatment can be used for fistulas smaller than 2 cm, but spontaneous recovery is unlikely for fistulas bigger than 3 cm4. If most of the urine escapes from the catheter after indwelling catheterization, then preservation therapy may be attempted. However, conservative treatment of fistulas following radiotherapy should be carefully considered. Most fistulae will not close spontaneously and require operative closure.
For fistula from surgery or birth injury, we recommend to undergo surgery after 12 weeks, while fistula from radiotherapy, the recommended time is one year later5,6. There are three general approaches that can be taken into consideration while determining the optimal surgical strategy. They are, in order, laparoscopic transvesical repair, extra peritoneal transvesical repair, and classic transvaginal repair. Initially, there are benefits to typical transvaginal repairs, including minimal blood loss, reduced trauma, elimination of the need to expose the bladder, and immunity to intestinal adhesion7,8,9. But given the small space, difficult exposure of high orifice fistula and inconvenient operation, traditional transvaginal repairs is primarily suitable for repairing low vesicovaginal fistula10,11,12. In addition, for extraperitoneal trans-vesical repair, the surgical field presents a top view. The bladder needs to be opened and the trauma is large. Besides it is hard to fully expose the lateral vaginal fistula, and there is no suitable surrounding tissue to block13. Finally, at present, most surgeons still prefer to open the bladder to locate the fistula or repair laparoscopically14. In most cases, the approach to VVF repair is often dictated by surgeons’ preference, location or complexity of the VVF15. The aim of this manuscript is to demonstrate the efficacy and safety of an alternative modified transvaginal repair technique(V-NOTES) for apical vesicovaginal fistula.
Patients and methods
Study population and design
We conducted a retrospective single-center investigation at our institution. 26 patients had apical VVFs diagnosed as a result of gynecological procedures between January 2020 and January 2023; 17 of these patients had had fistula closure at our facility. To define minimally invasive repair, strict exclusion criteria were applied, including sepsis, fecaluria, and fistulas larger than 2 cm in diameter. An evaluation of each patient’s medical history, physical examination, urine culture, vaginoscopy, and upper urinary tract ultrasound were all part of the standard preoperative evaluation. From the hospital archive, patient records have been obtained. Table 1 lists the baseline characteristics of the patients. Every technique used in this investigation complied with all applicable rules and regulations. Ethical approval was obtained from Ethics Committee on Biomedical Research, Renji Hospital of ShangHai JiaoTong University. All methods were performed in accordance with the relevant guidelines and regulations. Before this study, all participants gave informed written consent.
Preoperative evaluation
A standard preoperative evaluation had been performed in all patients, including medical history assessment, physical examination, urineculture, vaginoscopy, and ultrasound of the upper urinary tract. Computer tomography urography (CTU) was performed to exclude concomitant ureteral injury. Perifistula fibrosis refers to the replacement of normal tissue cells by fibrous tissue around a fistula after injury or inflammation, resulting in tissue hardening and functional impairment. Mild fibrosis: There is a slight increase in fibrous tissue with discontinuous distribution, and there is no stiffness in the tissue. Moderate fibrosis: There is significant fibrous tissue proliferation, presenting as patchy or banded, but no nodules have formed, and the tissue is locally stiff. Severe fibrosis: stable fibrous nodules of varying sizes are formed, and the tissue is significantly stiff.
Surgical techniques
The specific surgical technique used in the V-NOTES method sets it apart from traditional laparoscopic surgery. After general anesthesia, the patient was in the dorsal lithotomy position with her legs supported by knee supports. The thighs were relatively abducted, and the hips were flexed. Avoiding severe flexion and abduction of the thighs is crucial since the position may induce nerve injury (Fig. 1A)16. The camera assistant and the main surgeon were between the patient’s legs. The camera assistant sat on the chief surgeon’s right or left side and utilized the surgical scope while the assistant surgeon stood on the patient’s left or right side (Fig. 1B, C). When a V-NOTES port was inserted into the peritoneal cavity through the vagina, pneumoperitoneum was created (Fig. 1D). Two endoscopic tools were employed through the other two trocars, while a typical stiff 30-degree 10-mm laparoscope was used through one trocar.
Unlike conventional transvaginal repair, elevated vesicovaginal fistulas can be successfully exposed using V-NOTES (Fig. 2A, B). The extra scar tissue and vault epithelium are removed, but a ring of scar tissue that is very close to the fistula is retained in order to stop the fistula from getting bigger and causing more bleeding. The fistula is then sealed with a 3 − 0 Monocryl suture (Fig. 2C, D). To make sure the bladder isn’t leaking, we fill it with 300 milliliters of saline solution. Once the bladder’s impermeability has been established, we seal the perivesical tissue using a Halsted suture (Fig. 2E). The perivesical tissue is sutured to form the third layer of closure. Finally, the vaginal mucosa is sealed with a 3 − 0 Monocryl suture (Fig. 2F). With this revised method, the distance between the vaginal mucosa and the fistula tract mucosa is increased by forming three layers of closure in the perivesical tissue. Following surgery, antimuscarinics like tolterodine are recommended for four weeks, and antibiotics are administered for two weeks. For four weeks, the Foley catheter is left to drain.
Procedure for Transvaginal Repair of Apical Vesicovaginal Fistula via vNOTES. (A).A high vesicovaginal fistula(VVF) in our surgical field; (B). On the outside of the fistula, a circular incision is made at the normal mucosa. Then free the flap to the outside, but the scar and sinus tract on the inside of the incision are not necessary to cut; (C). Use 3 − 0 Monocryl suture to close the fistula; (D). Use 3 − 0 Monocryl again to close the incision for 2 ~ 3 layers; (E,F). Finally, close the vaginal mucosa with a 3 − 0 Monocryl suture.
Postoperative follow-up
Follow-up information was gathered via phone calls, outpatient visits, and hospital records. The final postoperative appointment includes a physical examination, a vaginoscopy, and a symptom assessment. On the fourteenth postoperative day, success was determined by the lack of leakage at cystography. External urinary diversions for incontinence as initial operations were not deemed successful. Secondarily, we assessed incontinence in the urine at a minimum 12-month follow-up.
Data analysis
A statistical analysis was performed. Normally distributed continuousparameters were presented as the mean ± standard deviation, and analyzed using paired Student t test in the pre- and postoperative comparison; non-normal distribution parameters were presented asmedian (range); and categorical parameters were presented as number(percentage). P < 0.05 was considered statistically significant.
Results
Seventeen individuals underwent physical examinations and took part in our medical review. A thorough summary of the patient and fistula features at the time of the initial surgery is provided in Table 1. The patients were 45.82 years old on average (36–53 years old). The average time between fistula onset and repair was 7.18 (3–12) months. Five of these fistulas (29.4%) were malignant, while ten (58.8%) exhibited benign disease. Following cesarean sections, two patients experienced VVFs.
The posterior wall of the ureter and the bladder triangle were the primary locations of the VVF. Three patients (17.6%) have two fistulas, while 14 patients (82.4%) have just one. Every fistula had a diameter of less than two centimeters. Of these individuals, 8 (47.1%) developed moderate or severe perifistula fibrosis, while 9 (52.9%) had mild or no perifistula fibrosis.
Table 2 displays surgical data, follow-up, and perioperative complications. 104.2 ± 12.2 min was the average operating duration, and the mean estimated blood loss was 10.45 ± 3.23 ml. The average length of hospitalization for patients after surgery was 3.34 ± 0.72 days. Out of 15 cases (88.2%), the VVF was successfully corrected; two individuals experienced failure. Two fistulas were present in both of these individuals who did not survive the procedure. A tiny amount of urine was still seen to flow out of the vesicovaginal fistula one month following surgery when the catheter was taken out and the cystoscope was examined again. Two months following the initial procedure, the patient had another one using the same technique. In the second repair, all two of the first failures were fixed. None of the 17 patients experienced any significant problems. Additionally, there was no infection in the location of the incision, urge incontinence, or temperature (> 38 °C). There was only one patient with minimal issues.
Discussion
Incontinence resulting from vesicovaginal fistula (VVF) represents the most distressing form among all possible types of this disorder that affects women. The continuous and relentless incontinence secondary to VVF has a significant and understandable negative impact on the quality of life of women with this disorder. In North America, the most frequent cause of VVF is bladder injury during a hysterectomy17. In underdeveloped countries, childbirth is the leading etiology of these fistulae17. The timing of VVF repair depends on its etiology, comorbidities, and the anticipated approach for fistula repair. The transvaginal approach is more suitable for early repair, is less invasive, and is associated with a 90% or higher success rate17. Fortunately, fistulae associated with gynecologic procedures are commonly amenable not only to early correction, but are most likely reparable by the less invasive transvaginal approach.
Treatment options for vesicovaginal fistulas include both conservative and surgical approaches. At the moment, laparoscopic/open transvesical repair is one of the suggested methods. The majority of surgeons still choose to expose the bladder to find the fistula. This is aptly described as “overlooking” and could allow for a more thorough disclosure of the bladder’s side fistula. The success rate of open transabdominal repair is greater. However, the recovery period is longer, the surgical stress is more severe, and patients are more likely to experience digestive issues after surgery.
A better view of extraperitoneal transvesical repair is provided by the operative field. It can be used for vesicovaginal fistulas in the upper and lower bladder, fistulas that have healed because of difficulties exposing the vaginal stricture, recurrent fistulas that have not been successfully repaired by transvaginal means, and more. This method does not necessitate opening the abdominal cavity and removes the challenge of freely attaching abdominal organs. The danger of ureteral damage is decreased since the relationship between ureteral fistula and ureteral injury is more obvious than with the transvaginal approach. However, doing so requires opening the bladder, which causes severe harm. Furthermore, the lateral vaginal fistula is difficult to fully expose, and there is insufficient surrounding tissue to prevent it. In cases of significant tissue damage, adhesion surrounding the fistula with infection, or a relatively narrow fistula compounded by ureteral injury, this surgery is not advised. It is still required to expose the peritoneum when the surgical field is too small or the procedure is cumbersome, which could result in more surgical stress.
The transvaginal procedure is a traditional surgical technique for vesicovaginal fistula repair. Reduced bleeding, less stress, no need for a bladder incision, little impact on intestinal adhesion, and a “looking up” visual field are some benefits of this approach. Furthermore, even in the event that the first repair fails, there are other choices for repair. However, exposing a high fistula is challenging, the area is limited, and the procedure is intricate. For this reason, it can be used to treat low vesicovaginal fistulas.
To treat patients with vesicovaginal fistulas, we developed a surgical technique called modified transvaginal natural orifice transluminal endoscopic surgery (V-NOTES). This method demonstrated positive efficacy and was successfully applied to male patients with urine incontinence. By enabling a thorough examination of the peritoneal cavity and providing continuous visual surveillance of the surrounding tissues, it would overcome the limitations of vaginal surgery.
By enabling thorough examination of the peritoneal cavity and ongoing visual control of the surrounding tissues, V-NOTES can get over the limitations of vaginal surgery. By utilizing the advantages of endoscopic surgery, the V-NOTES technique avoids the technical and surgical difficulties that come with traditional vaginal surgery. Furthermore, V-NOTES addresses problems associated with trocar-related complications and abdominal wall incisions by using low-cost, reusable, and handcrafted standard laparoscopic equipment. Fistulae healing in this way will have an 82–100% success rate.
One important advancement in the field of minimally invasive surgery is natural orifice transluminal endoscopic surgery (NOTES). Compared to other transluminal natural orifices such the mouth, rectum, urinary tract, or vagina, transvaginal NOTES (V-NOTES) have become the most popular18. The V-NOTES treatment combines the benefits of endoscopic surgery with the surgical and technical challenges of traditional vaginal surgery. Additionally, V-NOTES employs low-cost, reusable, handcrafted traditional laparoscopic tools and stays clear of issues with trocar-related difficulties and abdominal wall incisions. All things considered, this surgery leads to reduced postoperative pain, cosmetic benefits, and high patient satisfaction18. V-NOTES reduces the need to penetrate abdominal muscles and fascia and potential trocar problems when compared to traditional laparoscopy19. Additionally, the transvaginal NOTES groups’ hospital stays were significantly shorter than those of the standard laparoscopic groups. Its benefits include simpler closure, safe entrance, and ease of decontamination20. Hybrid V-NOTES actually reduces the inflammatory and neuroendocrine reactions because it is administered through natural orifices21.
There were certain restrictions on our investigation. With few prospective randomized controlled trials with sizable multi-center populations and most prior research being single-center retrospective studies, V-NOTES is an emerging surgical technique. Because NOTES requires more surgical skill than open surgery or regular laparoscopy, the transvaginal NOTES groups underwent longer surgical procedures than the traditional laparoscopy groups. The development of pure vNOTES is also limited by ethical concerns, which include putting patients through needless dangers during intricate procedures, a high risk of intra-abdominal infection, possible effects on the female genital system, and conservation concerns about manipulation through the female genital area. Due to the single-hole laparoscopic model, the operational cost can be higher.In conclusion, as one of the most significant developments in minimally invasive surgery since its start, V-NOTES has a promising future. In addition, we believe that VVF repair with V-NOTES is a practical, secure, and effective alternative to traditional methods.
Data availability
Data are available from the corresponding author if justification for the requirement is justified.
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Funding
This study was sponsered by Pudong New Area Peak Plateau Discipline Construction Clinical Medicine New Quality Specialty (2024-PWXZ-13); Key Discipline of Shanghai Health System (2024ZDXK0043); Top-level Clinical Discipline Project of Shanghai Pudong (No.PWYgf 2021-06).
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S.X.: conceptualization, methodology, data collection, data analysis, writing–original draft, and writing–review and editing; S.X. and J.C.: methodology, software, and writing–original draft; L.-J.W.: investigation, data analysis, writing–review and project administration.
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Song, X., Jiang, C. & Lv, Jw. Transvaginal repair of apical vesicovaginal fistula via vaginal natural orifice transluminal endoscopic surgery (V-NOTES): a modified surgical technique and its outcomes. Sci Rep 14, 31095 (2024). https://doi.org/10.1038/s41598-024-82366-y
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DOI: https://doi.org/10.1038/s41598-024-82366-y