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Efficacy and safety of Le Fort colpocleisis in the treatment of stage III-IV pelvic organ prolapse

BMC Women's Health volume 24, Article number: 618 (2024) Cite this article

Abstract

Background

Le Fort colpocleisis is an obliterative surgery for the treatment of pelvic organ prolapse (POP). In this study, we aimed to investigate the efficacy and safety of Le Fort colpocleisis in the treatment of patients with stage III-IV POP.

Methods

The study was designed as a retrospective analysis of a single-center case series. Patients with stage III-IV POP treated with Le Fort colpocleisis were included. Perioperative indicators, subjective and objective outcomes and complications were assessed. The POP-Quantification (POP-Q) system was used for objective outcome evaluation. Pelvic Floor Distress Questionnaire (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) were used for subjective outcome evaluation.

Results

A total of 54 patients with complete pre- and postoperative data completed follow-up and were included in our study. The mean ± standard deviation of operative time, intraoperative blood loss, recovery activity time, postoperative hospitalization time and total hospitalization time were 146.85 ± 37.01 min, 92.04 ± 68.31 ml, 2.81 ± 0.85 days, 6.5 ± 2.11 days and 13.52 ± 4.78 days, respectively. Within the median follow-up period of 38.5 months, the objective cure rate of Le Fort colpocleisis reached 98.15% (53/54), and the subjective cure rate reached 92.59% (50/54). No serious complications were reported during the perioperative period and follow-up period.

Conclusion

Le Fort colpocleisis is an effective and safe procedure for the treatment of severe POP. Because of its lower operative risk, better subjective and objective outcomes, lower rates of prolapse recurrence and perioperative complications, Le Fort colpocleisis should be considered as the recommended procedure for elderly patients with severe POP (stage III-IV).

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Introduction

POP is a common female condition, which is defined as a decrease in one or more aspects of the vagina and uterus: anterior vaginal wall, posterior vaginal wall, vaginal vault or uterus (cervix). It is difficult to estimate the prevalence accurately because the assessment methods (symptomatic questionnaires, clinical examination) vary from study to study, but it was estimated that the prevalence of POP was around 30%-50%and increased with age [1]. The choice of treatment depends on the compartment and severity of prolapse. In general, surgery remains an important treatment for severe POP and can be divided into reconstructive surgery and obliterative surgery. Reconstructive surgery aims to restore the anatomical position and function of the vagina and pelvic organs, while obliterative surgery aims to close the vaginal canal to prevent prolapse.

Le Fort colpocleisis is a well-established and proven obliterative surgery for POP and is recommended for elderly and frail patients [2], especially who cannot tolerate reconstructive surgery or have various medical comorbidities and do not require vaginal penetration. The American Urogynecologic Society and International Urogynecological Association define Le Fort colpocleisis as the closure of vaginal cavity by removing vaginal epithelium of the anterior and posterior vaginal walls and suturing the fibromuscular layers of them. Le Fort colpocleisis can be performed with uterus in situ or hysterectomy, thus it can be classified as Le Fort colpocleisis with hysterectomy, Le Fort colpocleisis without hysterectomy and Le Fort colpocleisis of vaginal vault [3].

In this study, we aimed to retrospectively analyze the efficacy and safety of Le Fort colpocleisis in patients with stage III-IV POP through a single-center case series, and hope to provide some basis for clinical practice.

Methods

Study design

The study design was a retrospective analysis of a single-center case series, which followed the STROBE guidelines [4]. Patients with stage III-IV POP treated with Le Fort colpocleisis at the First Affiliated Hospital of Guangzhou Medical University from January 2010 to March 2018 were included. Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, and informed consent was obtained from each patient. Considering the design of the study, the Ethics Committee determined that approval was not required.

Inclusion criteria

Severe POP (stage III-IV), inability to tolerate other pelvic floor reconstructive surgeries, no need for vaginal penetrative sex.

Exclusion criteria

Patients with previous prolapse surgeries, refusal to enroll, loss to follow-up, or incomplete data were excluded.

Data acquisition

We reviewed the electronic and paper medical records of all eligible patients and/or obtained demographic data from the medical records of patients enrolled in this study, including age at surgery, body mass index (BMI), maternal situation, menopausal status, scores for each POP-Q examination, and POP-Q stages.

Evaluation of POP

The POP-Q system is one of the most widely used international POP scoring methods and is the main basis for surgical objective success [5, 6]. We assessed the objective severity of POP in patients according to the POP-Q system: including Aa, Ba, C, TVL, Ap, Bp, gh, pb, and D points. Pelvic Floor Distress Questionnaire (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) scores were used to evaluate quality of life in patients with POP [7]. We used the PFDI-20 and PFIQ-7 to assess the subjective impact of POP on patients before and after surgery. The questionnaires were completed in the waiting room before physical examination and were not influenced by any health care provider. The PFDI-20 includes 3 subscale scale: Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8), and Urinary Distress Inventory (UDI-6). And the PFIQ-7 includes three subscales: Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7), Colorectal-Anal Impact Questionnaire (CAIQ-7), and Urinary Impact Questionnaire (UIQ-7). The score range for each subscale is 0 to 100, with higher scores indicating that patients are more affected and have a poorer quality of life.

Preoperative preparation

As part of the preoperative discussion, a detailed medical history was obtained, and gynecologic examination was performed on all patients. The patient’s surgical tolerance was assessed by medical history, physical examination, gynecological examination, coagulation function, and cardiopulmonary function assessment. Patients were asked to keep clean of the vulva and vagina with potassium permanganate sitz baths each night after hospitalization prior to surgery. Both preoperative and postoperative outpatient review were performed by an experienced surgeon in gynecologic urology.

Surgical procedure

All patients were placed in the lithotomy position. Transvaginal total hysterectomy was performed first; then Le Fort colpocleisis was performed (vaginal vault prolapse patients underwent direct Le Fort colpocleisis). The vaginal stump after transvaginal total hysterectomy was closed with 2–0 absorbable sutures. The anterior vaginal wall mucosa was separated sharply and stripped from the top of the vaginal vault to the level of the transverse vaginal sulcus (Fig. 1A). Similarly, the posterior vaginal wall mucosa was separated sharply and stripped from the top of vaginal vault to 2 cm above the vaginal orifice (Fig. 1B). The bilateral vaginal wall mucosa was reserved about 1.5 cm width on each side (Fig. 1C). Then, the reserved anterior, posterior and bilateral vaginal wall mucosa were sutured to encircle a drainage tube with 2–0 absorbable sutures in order to form a drain tunnel (Fig. 1D). It should be mentioned that drainage tubes were only used to form drain tunnels and would not be retained. After that No. 4 silk sutures were used to close the vaginal bladder fascia and vaginal rectal fascia from top to bottom (Fig. 1E). At last, the remained anterior and posterior vaginal mucosa at the vaginal orifice was closed with 2–0 absorbable sutures (Fig. 1F). The detailed surgical procedure may vary between studies, but vagina closure by suturing the mucosa of the anterior and posterior vaginal walls remains a key step in Le Fort colpocleisis. All patients underwent surgery by the same experienced surgeon in gynecologic urology at the same center.

Fig. 1
figure 1

Surgical procedures of Le Fort colpocleisis: A Stripping of the anterior vaginal wall mucosa; B Stripping of the posterior vaginal wall mucosa; C Reservation of the bilateral vaginal wall mucosa; D Formation of the “drain tunnel”; E Closing the vaginal bladder fascia and vaginal rectal fascia; F Closing the remained anterior and posterior vaginal mucosa

Full size image

Perioperative information

We recorded documented operative time (operative time from first incision to last suture, including simultaneous procedures), intraoperative blood loss, recovery activity time, postoperative or total hospitalization time, and perioperative complications. Early complications were defined as those occurring intraoperatively or within 4 weeks of surgery, whereas late complications were defined as any complication occurring after 4 weeks during the entire follow-up period.

Postoperative follow-up

All patients received postoperative outpatient and telephone follow-up (at least 12 months) by the same physician, including: interview, gynecologic examination, and questionnaires. Objective cure was defined as the lowest point of the pelvic organs not exceeding the level of the hymen under Valsalva maneuver, otherwise prolapse was considered recurrence. Subjective cure was defined as the absence of vaginal and pelvic organ prolapse symptoms after surgery, and the degree of clinical improvement of prolapse symptoms before and after surgery was assessed using PFDI-20 and PFIQ-7 questionnaires.

Statistical analysis

All statistical analyses were performed using SPSS 24.0 software (IBM Corp., Armonk, NY, USA). Continuous variables with normal distribution were expressed as mean ± standard deviation (SD) and compared using the paired t-test; variables with nonnormal distribution were expressed as median (range) and compared using the Wilcoxon signed rank test. Categorical variables were expressed as numbers (percentages) and compared using the chi-squared test or Fisher’s exact test. Differences were considered statistically significant with a two side P < 0.05.

Results

From January 2010 to March 2018, a total of 81 patients with stage III-IV POP were treated with Le Fort colpocleisis at our institution. Among them, 11 patients were lost and 16 patients had incomplete pre- and postoperative data. Finally, 54 patients completed follow-up and were included in our study. All results below were reported based on the last follow-up time point of each patient.

The baseline characteristics of included patients were summarized in Table 1. The patients had a mean age of 76.13 ± 7.68 years, a mean BMI of 24.59 ± 2.96 kg/m2, a median number of pregnancies of 5 (range: 2–10), a median number of deliveries of 3 (range: 1–8), a median follow-up period of 38.5 (range: 14–101) months. Pelvic examinations to determine POP-Q staging showed that 22 cases (40.74%) had stage III POP and 32 cases (59.26%) had stage IV. Table 2 showed the detailed preoperative POP-Q stage and prolapse compartment distribution of included patients.

Table 1 Baseline characteristics of included patients
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Table 2 Preoperative POP-Q stage and prolapse compartment distribution of included patients
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The intra- and postoperative information of included patients was reported in Table 3. The mean operative time was 146.85 ± 37.01 min. The intraoperative blood loss was 50 ml (range: 20–350). The recovery activity time was 3 days (range: 2–6). The postoperative hospitalization time was 6 days (range: 4–13). The total hospitalization time was 13 days (range: 7–30). Concomitant surgeries were observed including hysterectomy in 46 cases (85. 19%), perineal reconstruction in 41 cases (75.93%), anti-incontinence surgery in 16 cases (29.63%), TVT-A in 6 cases (11.11%), TVT-O in 7 cases (12.96%), and TVT-E in 3 cases (5.56%). Perioperative complications included fever in 4 cases (7.41%) and urinary tract infection in 3 cases (5.56%). Only 1 patient reported recurrence of prolapse during the follow-up period, and the objective cure rate of Le Fort colpocleisis in this study was 98.15% (53/54).

Table 3 Intra- and postoperative information of included patients
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Table 4reported the subjective outcomes of patients according to PFDI-20 and PFIQ-7 questionnaires at preoperative and final follow-up time. Based on published studies [8], we chose a strict threshold of 70% to determine clinical improvement, which was defined as a ≥ 70% decrease in the patient’s postoperative PFDI-20 and PFIQ-7 scores compared to the preoperative scores. PFDI-20 improved in 100% of patients at the final follow-up compared to the preoperative period, 87.04% of patients achieved clinical improvement, and an additional 12.96% of patients did not reach the definition of clinical improvement with ≥ 70% decrease in score. The three subscales of PFDI-20: POPDI-6, CRADI-8, and UDI-6, showed clinical improvement rates of 100%, 5.56% and 37.04%, respectively. The 87.04% and 40.74% of patients with no change in CRADI-8 and UDI-6 at the final follow-up may have contributed to the lower clinical improvement rates for these two subscales. PFIQ-7 improved in 100% of patients at the final follow-up compared to the preoperative period, 85.19% of patients achieved clinical improvement, and an additional 14.81% of patients did not reach the definition of clinical improvement with ≥ 70% decrease in score. The three subscales of the PFDI-7: POPIQ-7, CRAIQ-7, and UIQ-7, showed clinical improvement rates of 98.15%, 7.41%, and 35.19%, respectively. The 79.63% and 48.15% of patients with no change in CRAIQ-7 and UIQ-7 at the final follow-up may have contributed to the lower clinical improvement rates for these two subscales. Only 4 patients did not achieve clinical improvement in both PFDI-20 and PFIQ-7 during the follow-up period, while the remaining patients achieved clinical improvement in at least one questionnaire. Therefore, the subjective cure rate of Le Fort colpocleisis in this study was 92.59% (50/54). In addition, compared to the preoperative period, patients’ scores on all questionnaires were significantly lower at the final follow-up time, except for CRADI-8 and CRAIQ-7 (Table 5).

Table 4 Results of questionnaires at preoperative and last follow-up time
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Table 5 Comparison of questionnaires between preoperative and last follow-up time
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In order to investigate the effect of concomitant hysterectomy during Le Fort colpocleisis, we compared the intra- and postoperative information of patients with/without concomitant hysterectomy in Table 6. Concomitant hysterectomy resulted in less intraoperative blood loss but longer operative time, recovery activity time, postoperative hospitalization time, and total hospitalization time, however, none of these indicators were statistically significant.

Table 6 Intra- and postoperative information of patients with/without concomitant hysterectomy
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Table 7 compared the intra- and postoperative information for patients with/without concomitant anti-incontinence surgery. Concomitant anti-incontinence surgery resulted in more intraoperative blood loss, longer operative time, recovery activity time, postoperative hospitalization time, and total hospitalization time, but none of these indicators were statistically significant except for operative time.

Table 7 Intra- and postoperative information of patients with/without concomitant anti-incontinence surgery
Full size table

Discussion

Le Fort colpocleisis is widely used in urogynecological surgery, especially elderly patients with severe POP. The present study found that the objective cure rate was 98.15%, and subjective cure rate was 92.59%. The high subjective and objective cure rates are consistent with the results of previous studies. In addition, we observed that only 1.85% patients reported postoperative pulmonary embolism complications during the perioperative period, 11.11% patients reported minor complications: including fever, urinary tract infection, hematuria, ankle arthritis, and dorsal foot erythema. None of them reported serious complications during the follow-up period. Thus, we can conclude that Le Fort colpocleisis is both effective and safe for the treatment of severe POP (stage III-IV).

With low anesthesia requirements, less damage to adjacent organs, tissues, blood vessels, and nerves, and a surgical approach that does not require access to the abdominal cavity, low operative risk, and rare serious adverse events, Le Fort colpocleisis is widely regarded as an effective and safe procedure with a high surgical success rate, typically 91%-100% [9]. Previous studies have reported that Le Fort colpocleisis is associated with more than 95% long-term outcomes, low risk of patient regret, and high satisfaction [10, 11]. A decision analysis model showed that Le Fort colpocleisis had the best expected overall benefit in women aged 40–90 years, which increased with age [12]. Shah et al. [13] compared the efficacy of various reconstructive and obliterative surgeries and showed that Le Fort colpocleisis provided the most durable overall prolapse repair outcomes with the lowest reoperation and retreatment rates. Drain et al. [14] compared the perioperative complications of POP surgery in women over 75 years of age, and the results supported Le Fort colpocleisis as a safe surgical treatment for advanced pelvic organ prolapse with relatively low surgical risk, even in the elderly.

Some studies have shown that Le Fort colpocleisis has a shorter operative time, less blood loss, and fewer complications than reconstructive surgery [15, 16]. There have been many studies on complications of Le Fort colpocleisis: a review study by FitzGerald et al. [9] showed a cardiopulmonary and cerebrovascular complication rate of approximately 5% and a minor complication rate of 15% for Le Fort colpocleisis. A study by Hullfish et al. [17] found minor complications in 18 out of 94 patients (19.15%), of which 4 patients (4.26%) had urinary tract infections. A study by Kinci et al. [18] reported pulmonary atelectasis in only 1 out of 59 patients (1.69%) and minor complications in 2 patients (3.38%), all of which were urinary tract infections.

Recently, a large study in the United States found that 22% of Le Fort colpocleisis patients with concomitant hysterectomy, and specifically, 43.4% of patients with uterine prolapse were combined with concomitant hysterectomy [19]. In fact, there has been controversy about whether Le Fort colpocleisis should be combined with concomitant hysterectomy, which is performed to reduce the potential risk of uterine malignancy (endometrial cancer, cervical cancer, etc.) and to help reduce the risk of recurrence and improve the repair outcome of POP on the other hand [9, 20], but physicians and patients should weigh the lower risk of concomitant uterine malignancy against the higher potential complications associated with concomitant hysterectomy. The International Continence Society (ICS) clinical guideline states that “Le Fort colpocleisis without hysterectomy is preferred to vaginal hysterectomy and total Le Fort colpocleisis when there is no specific indication for hysterectomy and no interest in preserving coital function” [21]. A decision analysis concluded that Le Fort colpocleisis alone is preferable to concomitant hysterectomy in women over 40 years of age [12]. Previously, Le Fort colpocleisis with hysterectomy was reported to be associated with longer operative time, more intraoperative blood loss, and higher intraoperative transfusion rate. Gan et al. [22] found that uterus-preserving Le Fort colpocleisis resulted in less intraoperative blood loss and shorter operating room time, but long-term outcome data remain variable and limited. Raina et al. [19] reported that Le Fort colpocleisis with hysterectomy resection was associated with an increased risk of complications, with a ratio of 1.927 (1.445–2.568, p < 0.001) for women undergoing concomitant hysterectomy for any complication, using women without concomitant hysterectomy as a reference. Bochenska et al. [23] observed a significantly increased risk of serious medical complications after concomitant hysterectomy, suggesting that Le Fort colpocleisis should not be routinely combined with concomitant hysterectomy unless there is a specific uterine or cervical pathology that requires hysterectomy. Contrary to the study by Ozceltik et al. [24], who showed that concomitant hysterectomy did not affect perioperative outcomes beyond the operative time, there was no increased risk of intraoperative blood loss and serious medical complications.

In this study, concomitant hysterectomy was associated with longer operative time, recovery activity time, postoperative hospitalization time, and total hospitalization time; however, it resulted in less intraoperative blood loss. Furthermore, the rate of perioperative complications in patients with concomitant hysterectomy (13.04%) was comparable to that in patients without concomitant hysterectomy (12.50%), suggesting that concomitant hysterectomy does not increase the risk of perioperative complications. Unfortunately, the comparison of these perioperative indicators did not reach statistical significance due to the small sample size and large difference in numbers between the two groups. To obtain higher quality evidence for guiding surgical approaches, better prospective studies evaluating Le Fort colpocleisis with hysterectomy are needed.

Although our findings do not indicate a higher risk associated with concomitant hysterectomy, we recommend considering Le Fort colpocleisis with hysterectomy only for patients at risk of abnormal postmenopausal vaginal bleeding or other uterine malignancies while respecting their personal choice after adequate preoperative education.

There is a current opinion that one should be aware of the occurrence of new postoperative urinary incontinence after Le Fort colpocleisis, with an incidence of approximately 1–11% reported in the literature [9]. Le Fort colpocleisis alters the original pelvic anatomy and the new anatomical position or excessive stretching of the urethra due to intraoperative manipulation may be the main cause of postoperative incontinence. A review study by Felder et al. [25] showed that persistent or new onset of urinary symptoms were the main reason why patients regretted Le Fort colpocleisis, even more than surgical complications and loss of sexual function. A study by Zhang et al. [26] reported that 2 patients (4.26%) who did not undergo anti-incontinence surgery developed new postoperative incontinence, and concomitant anti-incontinence surgery was performed in 11 patients with definite SUI who underwent Le Fort colpocleisis, and 2 patients developed postoperative leakage due to mild cough, but none had difficulty voiding. The ACOG Practice Bulletin concluded that in patients without SUI [27], without prophylactic anti-incontinence surgery leads to a higher incidence of new postoperative incontinence, but concomitant surgery increases the risk of adverse events.

In terms of these opinions, our study observed that 3 patients (7.89%) who underwent concomitant anti-incontinence surgery developed new postoperative incontinence. Among the 22 patients with definite SUI, 16 opted for concomitant anti-incontinence surgery and all experienced relief from SUI symptoms after the procedure. The remaining 8 patients either chose not to undergo concomitant anti-incontinence surgery or decided to have it at a later time. Concomitant anti-incontinence surgery was associated with increased intraoperative blood loss, longer operative time, recovery activity time, postoperative hospitalization time, and total hospitalization time. However, none of these associations were statistically significant except for operative time. It is worth noting that the rate of perioperative complications was much higher in patients with concomitant anti-incontinence surgery (31.25%) than in those who without (5.26%), suggesting that concomitant anti-incontinence surgery does increase the risk of perioperative complications, consistent with previous studies. Therefore, physicians and patients should carefully consider the risk of complications from prophylactic anti-incontinence surgery against the risk of new postoperative incontinence.

Limitations

The strengths of the present study lie in the utilization of the POP-Q system and Pelvic Floor Questionnaires to assess the efficacy and safety of Le Fort colpocleisis for treating stage III-IV POP. Additionally, we have addressed complications associated with Le Fort colpocleisis and explored whether concomitant hysterectomy or anti-incontinence surgery should be accompanied. We are confident that our findings make a valuable addition to current research in this field.

However, it is important to acknowledge certain limitations of our study, including a small sample size and its single-center nature. Other limitations include incomplete data collection and analysis regarding preoperative and postoperative test results for Le Fort colpocleisis, absence of satisfaction questionnaires or assessment of regret risk, as well as lack of comparison with other POP procedures, etc.

Conclusion

In conclusion, Le Fort colpocleisis has lower operative risk and better subjective and objective outcomes, with lower rates of prolapse recurrence and perioperative complications. This procedure should be considered as the recommended procedure for elderly patients with severe POP (stage III-IV).

Data availability

All relevant data and materials of this study were included within this published article.

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Acknowledgements

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Funding

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Author notes

  1. Leqi Liang and Shan Ao contributed equally to this work.

Authors and Affiliations

  1. Department of Urology and Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Kangda Road 1#, Haizhu District, Guangzhou, Guangdong, 510230, China

    Leqi Liang, Shan Ao, Su Wang, Zugen Chen, Lei Peng, Liquan Chen, Lizhen Xu, Xiaowei Zhang & Tuo Deng

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  1. Leqi Liang
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All authors contributed to the study conception and design. Data collection, statistical analyses and draft of manuscript writing were performed by Leqi Liang and Shan Ao. Patient follow-up was conducted by Tuo Deng and Xiaowei Zhang. All authors commented on and edited the previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Xiaowei Zhang or Tuo Deng.

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Ethics approval and consent to participate

All methods in this study were carried out in accordance with the Helsinki and STROBE guidelines. This study was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, China. Written informed consent was obtained from participants. Given the design of the study, the Institutional Review Board of the First Affiliated Hospital of Guangzhou Medical University ruled that approval was not needed.

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Not applicable.

Compteting interests

The authors declare no competing interests.

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Liang, L., Ao, S., Wang, S. et al. Efficacy and safety of Le Fort colpocleisis in the treatment of stage III-IV pelvic organ prolapse. BMC Women's Health 24, 618 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12905-024-03459-4

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12905-024-03459-4

Keywords

BMC Women's Health

ISSN: 1472-6874

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