Transvaginal Repair of Apical Vesicovaginal Fistula via Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES): A Modified Surgical Technique and Its Outcomes

doi:10.21203/rs.3.rs-4958059/v1

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Transvaginal Repair of Apical Vesicovaginal Fistula via Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES): A Modified Surgical Technique and Its Outcomes

https://doi.org/10.21203/rs.3.rs-4958059/v1

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Objective

To report the procedure of an alternative modified transvaginal repair technique (V-NOTES) and their outcomes in apical vesicovaginal fistula.

Methods

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.

Results

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 ± 3.23ml, and the average operative time was 104.2 ± 12.2min. 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.

Conclusions

Our study suggest that the transvaginal repair of apical VVF via V-NOTES is effective and safety, and offers anticipated results without obvious complications.

Health sciences/Diseases

Health sciences/Health care

Health sciences/Urology

Apical vesicovaginal fistula

V-NOTES

Surgical technique

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 ischemia.¹ VVF has remained a disaster and of public health significance, causing remarkable morbidity, and psychological and physical problems to the patient.² 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 treatment.⁴

The fistula which is smaller than 2cm can be treated conservatively, but the possibility of spontaneous recovery for the fistula which is larger than 3cm istiny.⁵ 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 later.^6,7 As for the best surgical approach, there are three ways can be considered typically. They are traditional transvaginal repair, extra peritoneal transvesical repair and laparoscopic trans-vesical repair respectively. Firstly, for traditional transvaginal repairs, there are advantages such as low blood loss, less trauma, no need to open the bladder and no effect of intestinal adhesion.^3,8,9 But given the small space, difficult exposure of high orifice fistula and inconvenient operation, traditional transvaginal repairs is primarily suitable for repairing low vesicovaginal fistula.^10–12In 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 block. ¹³Finally, at present, most surgeons still prefer to open the bladder to locate the fistula or repair laparoscopically.¹⁴ 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.

2.1. Study population and design

In our institution, a retrospective single-center study was carried out. Between January 2020 and January 2023, gynecological procedures resulted in the diagnosis of apical VVFs in 26 patients, 17 of whom had undergone fistula repair in our center. Strict exclusion criteria, such as a fistula with a diameter greater than 2 cm, sepsis, and/or fecaluria, were used to define minimally invasive repair. Every patient had undergone a normal preoperative evaluation, which included an assessment of their medical history, a physical examination, a urine culture, a vaginoscopy, and an upper urinary tract ultrasound. Patients’ records have been retrieved from the hospital archive. Baseline patient characteristics are listed in Table 1. All methods in this study were performed in accordance with relevant guidelines and regulations. All patients gave written informed consent. Ethical approval was obtained from Ethics Committee on Biomedical Research, Renji Hospital of ShangHai JiaoTong University, No. 20511105403.

Table 1

Patients’ characteristics at the time of first surgery.
Patient	Age (yr)	Duration (mo)	Etiology	Fistula location	Fistula number	Fistula size(cm)	Perifistula fibrosis
1	42	12	cervical carcinoma	1cm posterior to the left ureter; bladder triangle	2	1.5/0.8	Moderate-severe
2	46	3	Hysteromyoma	1cm posterior to the left ureter	1	0.8	Mild/ no fibrosis
3	51	11	cervical carcinoma	1cm posterior to the right ureter	1	0.8	Moderate- severe
4	43	5	Uterine leiomyoma	1cm posterior to the right ureter; bladder triangle	2	1.2/0.7	Mild/ no fibrosis
5	44	8	Adenomyosis	2cm posterior to the left ureter	1	1.0	Mild/ no fibrosis
6	36	9	Hysteromyoma	interureteral ridge	1	0.8	Moderate- severe
7	47	5	Cesarean section	1cm posterior to the left ureter	1	0.5	Mild/ no fibrosis
8	52	5	Cesarean section	1cm posterior to the right ureter	1	0.5	Mild/ no fibrosis
9	42	10	cervical carcinoma	2cm posterior to the left ureter	1	0.8	Moderate- severe
10	37	6	Adenomyosis	bladder triangle	1	0.8	Mild/ no fibrosis
11	53	6	Hysteromyoma	bladder triangle	1	1.2	Mild/ no fibrosis
12	41	12	cervical carcinoma	2cm posterior to the left ureter	1	1.8	Moderate- severe
13	46	6	Hysteromyoma	bladder triangle	1	0.8	Moderate- severe
14	52	5	Hysteromyoma	bladder triangle	1	1.0	Mild/ no fibrosis
15	53	3	Adenomyosis	Posterior left ureter; bladder triangle	2	1.0/0.8	Mild/ no fibrosis
16	46	8	cervical carcinoma	2cm posterior to the right ureter	1	1.5	Moderate- severe
17	48	8	Hysteromyoma	bladder triangle	1	1.0	Moderate- severe

2.2. 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.

2.3. Surgical techniques

The v-NOTES procedure differs from conventional laparoscopic surgery in its particular surgical approach. The patient was in the dorsal lithotomy position, her legs supported by knee supports, following general anesthesia. The hips were flexed and the thighs were comparatively abducted. It is imperative to refrain from excessive flexion and abduction of the thighs as this may result in nerve damage caused by the position (Fig. 1A). Between the patient's legs were the chief surgeon and the camera assistant. While the assistant surgeon stood on the left or right side of the patient, the camera assistant sat on the chief surgeon's right or left side and used the surgical scope (Fig. 1B,C). Pneumoperitoneum was established when a V-NOTES port was introduced via the vagina into the peritoneal cavity (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.

In contrast to traditional transvaginal repair, V-NOTES can effectively expose high vesicovaginal fistulas (Fig. 2A,B). In order to prevent the fistula from growing larger and causing further bleeding, the excess scar tissue and vault epithelium are removed, but a ring of scar tissue that is extremely near to the fistula is kept. After that, a 3 − 0 Monocryl suture is used to seal the fistula (Fig. 2C,D). We add 300 milliliters of saline solution to the bladder to ensure there is no leaking. After confirming that the bladder is impermeable, we use a Halsted suture to close the perivesical tissue (Fig. 2E). The third layer of closure is created by suturing the perivesical tissue. Lastly, a 3 − 0 Monocryl suture is used to seal the vaginal mucosa (Fig. 2F). This updated approach involves the creation of three layers of closure in perivesical tissue, increasing the distance between the vaginal mucosa and the fistula tract mucosa. After surgery, antibiotics are applied for 2 wk, and antimuscarinics such as to lterodine are prescribed for 4 wk. Foley catheter is kept for 4 wk to drain.

2.4. Postoperative follow-up

Follow-up data were obtained from hospital records, outpatient visits, and phone calls. In the last postoperative visit, symptom assessment, physical examination, and vaginoscopy are performed. Success was defined as the absence of leakage at cystography on the 14th postoperative day. External incontinent urinary diversions as first procedures were not considered a success. Secondarily, we evaluated urinary incontinence at a minimum follow-up of 12 mo.

2.5. 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.

Seventeen patients participated in our medical review and undergo physical examination. The characteristics of patients and fistulas at the time of first surgery are carefully summed(Table 1). 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. Among these fistulas,10(58.8%) had a benign pathology, and 5(29.4%) were malignant. Two patients developed VVFs after cesarean section.

The VVF was mostly located at bladder triangle and the posterior wall of the ureter. Of the patients, 14(82.4%) only has one fistula and 3(17.6%) has two fistulas. All fistulas were small in size(< 2cm in diameter). Among these patients, 9(52.9%) has mild or no perifistula fibrosis while 8(47.1%) developed moderate to severe perifistula fibrosis.

Surgical data, perioperative complications, and follow-up are shown in Table 2. The mean estimated blood loss was 10.45 ± 3.23ml, and the average operative time was 104.2 ± 12.2min. 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. Only 1 patient had minor complications.

Table 2

– Surgical data, perioperative complications, and follow-up.
Parameter	Data
Estimated blood loss, ml	10.45 ± 3.23
Operative time,min	104.2 ± 12.2
Postoperative hospital stay, days	3.34 ± 0.72
Success rate, no. (%)
First repair	15/17(88.2%))
Second repair	2/2(100%))
Complications, n (%)
Major complications	0
Minor complications	1/17(5.9%))
Fever > 38 C	0
Infection in incision area	0
Urge incontinence	0

Incontinence due to VVF is the most miserable of all possible types of this disorder affecting women. Continuous and unrelenting incontinence secondary to VVF has a powerful and understandably negative impact on the quality of life of the woman with this disorder. The most common cause of VVF in North America is injury to the bladder during a hysterectomy.¹⁶ In underdeveloped countries, childbirth is the leading etiology of these fistulae.¹⁶ The timing of repair of the VVF is dependent on its etiology, comorbidities, and the anticipated approach for repair of the fistula. The transvaginal approach is more amenable to an early repair, is less invasive, and is accompanied by a 90% or higher success rate.¹⁶ 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.

The methods for the treatment of vesicovaginal fistula are conservative treatment and surgical treatment. Laparoscopic/open transvesical repair is currently one of the recommended method. Most surgeons still choose to open the bladder to locate the fistula. It is vividly called "overlooking", which could expose the fistula more fully on the side of the bladder. The success rate of open transabdominal repair is higher. However, the surgical trauma is larger, the postoperative recovery time is longer, and postoperative patients are prone to intestinal complications.

For extraperitoneal trans-vesical repair, the surgical field presents a top view. It is suitable for the vesicovaginal fistula with the fistula located in the upper part and the bottom of the bladder, the vesicovaginal fistula repaired by vaginal stricture exposure difficulty, the vesicovaginal fistula and the recurrent fistula with failed transvaginal repair. This operation does not need to open the abdominal cavity and avoids the difficulty of free adhesion of abdominal organs. Compared with the transvaginal approach, we can clearly see the relationship between ureteral fistula and ureteral fistula, which reduces the possibility of ureteral injury. However, 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 block. And this procedure is not recommended when the fistula is relatively narrow, complicated with ureteral injury or severe tissue injury and adhesion around the fistula with infection. When the surgical field is not big enough or the operation is inconvenient, it is still necessary to open the peritoneum, which may lead to larger surgical trauma.

Transvaginal repair of vesicovaginal fistula is a traditional surgical method. The visual field of the operation is "looking up", less bleeding, less trauma, no need to cut open the bladder, and no effect on intestinal adhesion. Even if the repair fails, we can still choose other ways to repair. But the space is small, the exposure of high fistula is difficult, and the operation is difficult. So it is suitable for repairing low vesicovaginal fistula.

In this context, for the treatment of vesicovaginal fistula patients, we made innovative improvements and adjustments to the conventional sling technique and proposed a modified transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) surgical technique that would overcome the limitations of vaginal surgery by allowing a complete exploration of the peritoneal cavity and a constant visual control of the adjacent structures, which was successfully applied to the treatment of male urinary incontinence patients, and achieved good efficacy.

V-NOTES would allow full exploration of the peritoneal cavity and continuous visual control of the surrounding tissues, so overcoming the limits of vaginal surgery. By using the benefits of endoscopic surgery, the V-NOTES treatment gets around the surgical and technical challenges of traditional vaginal surgery. Moreover, V-NOTES eliminates issues with abdominal wall incisions and trocar-related difficulties by using low-cost, reusable, handcrafted traditional laparoscopic equipment. Fistulae repaired in this manner will have a success rate ranging between 82% and 100%

Natural orifice transluminal endoscopic surgery (NOTES) is a significant innovation in the field of minimally invasive surgery. Transvaginal NOTES (V-NOTES) has gained the most popularity than other transluminal natural orifices such as mouth, rectum, urinary tract or vagina¹⁷. The V-NOTES procedure overcomes the surgical and technical difficulties of conventional vaginal surgery by incorporating the advantages of endoscopic surgery. Moreover, V-NOTES uses inexpensive, reusable, handmade conventional laparoscopic instruments and avoids those problems related to abdominal wall incisions and trocar-related complications. Overall, this procedure results in high patient satisfaction, cosmetic advantages, and decreased postoperative pain¹⁷. Compared with conventional laparoscopy, V-NOTES eliminates the need of penetrating abdominal muscles and fascia and possible complications related to the trocar¹⁸. Besides the length of hospital stay was much shorter in the transvaginal NOTES groups compared to the traditional laparoscopic groups. It has the advantage of fewer complications, ease of decontamination, and provision of safe entry and simple closure¹⁹. In fact, because hybrid V-NOTES is performed through natural orifices, it decreases the inflammatory and neuroendocrine responses²⁰.

Exactly, there are also some disadvantages about VNOTES. For example, V-NOTES is an emerging surgical method and previous studies were mostly single-center retrospective studies, and there is a lack of prospective randomized controlled studies with large multi-center samples¹⁸. With regards to surgery, the transvaginal NOTES groups experienced longer surgical times compared to traditional laparoscopic because NOTES require more surgical skills compared to open surgery or traditional laparoscopy¹⁸. On the other hand, ethical issues, including exposing patients to unnecessary risks during the complex procedures, high risk of intra-abdominal infection, potential influence on the female genital system, and conservation opinions about manipulating through female genital area, also limit the development of pure vNOTES¹⁸. Because of the single-hole laparoscopic model, the operation cost may be higher²¹.

In summary, V-NOTES has a bright future ahead of it as one of the biggest advancements in minimally invasive surgery since its inception. Furthermore, we think that VVF repair using V-NOTES is a workable, safe, and efficient substitute for conventional procedures.

Conflicts of interest disclosure

There were no conflicts of interest among all authors

Ethical approval

Ethical approval was obtained from Ethics Committee on Biomedical Research, Renji Hospital of ShangHai JiaoTong University.

Sources of funding

This study was sponsered by Top-level Clinical Discipline Project of Shanghai Pudong(No.PWYgf 2021-06)；Pudong New Area Traditional Chinese and Western Medicine collaborative flagship Department (Urology) construction plan (YC-2023-0405).

Data availability statement

Data are available from the corresponding author if justification for the requirement is justified.

Author contribution

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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No competing interests reported.

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You are reading this latest preprint version

Transvaginal Repair of Apical Vesicovaginal Fistula via Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES): A Modified Surgical Technique and Its Outcomes

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusions

Figures

1. Introduction

2. Patients and methods

2.1. Study population and design

2.2. Preoperative evaluation

2.3. Surgical techniques

2.4. Postoperative follow-up

2.5. Data analysis

3. Results

4. Discussion

Declarations

References

Additional Declarations

Status:

Version 1