Anatomical and Symptomatic Outcomes in Patients With Le Fort Colpocleisis

Mehmet Ferdi KINCI (  drferdikinci@gmail.com ) Muğla Sıtkı Koçman University Education and Research Hospital Burak SEZGİN Muğla Sıtkı Koçman University Education and Research Hospital Mehmet Onur ARSLANER Muğla Sıtkı Koçman University Education and Research Hospital Deniz AKIN GÖKBEL Muğla Sıtkı Koçman University Education and Research Hospital İsmail GÖKBEL Menteşe State Hospital Ahmet Akın SİVASLIOĞLU Muğla Sıtkı Koçman University Education and Research Hospital


Background
The incidence of pelvic organ prolapse (POP) lies in the range of 1.5-49/10000, although it may vary by several factors, especially age [1]. Women have an estimated 10-20% lifetime risk of undergoing POP repair according to several studies [2,3]. As a result of the increasing life expectancy, a steadily rising number of POP surgeries will likely be demanded from gynecologists. POP surgeries are mainly classi ed into as reconstructive and obliterative methods [2]. The decision on the surgical method depends on a plethora of factors including patient age, overall condition, comorbid disease status, POP severity, and sexual life. Le Fort colpocleisis is one of the obliterative modalities preferred in elderly patients who are no longer sexually active.
Le Fort colpocleisis was rst described in 1877 by Leon Le Fort as a surgical procedure which basically involves closing the vagina wherein pubocervical fascia (PCF) and rectovaginal facia (RVF) are approximated and sown along the midline. Anatomical success rates up to 98% have been reported [4]. A modi cation to the Le Fort operation was introduced over time by Goodall and Power who described excision of a triangular piece from the vagina to allow for coitus [5].
In the literature, there are not su cient studies about Le fort colpocleisis that present anatomical and clinical results together. In this study, we have prospectively analyzed Le Fort colpocleisis operations carried out in our department. Here, we have evaluated the anatomical outcomes of the surgery using pelvic organ prolapse quanti cation (POP-Q) in addition to the clinical outcomes which were assessed through queries on Global Pelvic Floor Bother Questionnaire (GPFBQ).

Study Design
The study included 59 patients who were diagnosed with vaginal or utero-vaginal prolapse and therefore underwent Le Forte colpocleisis either alone or in combination with other gynecological surgeries during the time period of January 2016 and October 2020. This study has been approved by the Mugla Sitki Kocman University Clinical Research Ethics Committee (Ethics approval date: Jul 02, 2020, No:07/VI). As a part of pre-operative procedure, a detailed medical history was retrieved and gynecological examination was applied to all patients. Before the operation, all the patients were counselled about the desire for future vaginal intercourse. The surgery was planned for the patients with no intention to have any sexual intercourse according to counselling result. Pre-operative and post-operative outpatient follow-up examinations as well as the surgeries were all performed by two surgeons experienced in urogynecology (AAS and MFK). Informed consent was obtained from all participants.
When patients were scheduled for the surgery, queries were conducted to record about age, gravidity, parity, body mass index (BMI), comorbid diseases, history of any previous surgeries, and lower urinary tract symptoms (LUTS). LUTS such as stress urinary incontinence (SUI), frequency, urgency, urinary leakage with urgency, di culty in urination, bulging of vagina, obstructive defecation, fecal incontinence were assessed by using Turkish validated Global Pelvic Floor Bother Questionnaire (GPFBQ) [6]. Prolapse was graded through POP-Q classi cation during gynecological examination [7]. Complications were evaluated according to the Clavien-Dindo classi cation and classi ed using the joint project of the International Continence Society and the International Urogynecological Association Prosthesis/Graft Complication Classi cation System [8,9].

The Surgery
All patients were placed in lithotomy position. Then spinal anesthesia was performed. A rectangular incision was made on the anterior aspect of vaginal wall starting from the level of 0.5 cm distal to the urethral ori ce extending until 1 cm is left before reaching the anterior cervical lip. Vaginal mucosa was denuded off the PCF. Then, posterior vaginal wall was also excised in a rectangular shape, initiating from the insertion point of uterosacral ligaments extending until 1 cm is left before the posterior cervical lip. Vaginal mucosa was denuded off the RVF. The edges of lateral residual vaginal mucosal walls were tied using no: 2/0 polyglactin suture forming a drain tunnel. Afterwards, PCF at the anterior wall and RVF at the posterior wall were aligned along vertical plane. Then no: 2/0 polyglactin was used to suture PCF to RVF for vaginal closure (Video-1).
Postoperative Follow-up Urinary catheter was retracted, and a complete blood count sample was collected 24 h after the surgery.
Patients were discharged to home at 48 hours provided no complications have occurred. All patients were inspected at post-operative 1 and 12 months. During the follow-up conducted at our outpatient department 12 months after the surgery, the same set of GPFBQ questioned pre-operatively was requestioned and the anatomical marker of total vaginal length (TVL) and genital hiatus (Gh) as well as the location called C point, all of which are the measurement parameters included in POP-Q scoring system, were re-evaluated (Table-1).

Statistical Analysis
Statistical analysis was carried out using SPSS software (IBM SPSS Statistics, Version 22.0. Armonk, NY: IBM Corp). Shapiro-Wilk test was applied to assess distribution of variances. Variables with a normal distribution were presented as mean±standard deviation (SD). The comparison of pre-operative and postoperative hemoglobin (Hb) values was accomplished using paired-samples t-test. The relationship of GPFBQ between pre-operative and post-operative groups was analyzed using Chi-square test. Values of p<0.05 were accepted as statistically signi cant.

Results
A total of 59 patients were included in the study. The average age of the patients was 71.67±7.01 (years).
These women had a parity of 3.20±1.12, on average. Mean BMI was 27.1±9.52 kg/m 2 . Prior surgical history included vaginal hysterectomy + culdoplasty in three patients, cataract in seven patients, and knee prosthesis implantation in four patients. The comorbid diseases of the patients are shown in Table-2. Vaginal hysterectomy in combination with colpocleisis was applied in 22 patients, while 37 patients underwent colpocleisis alone.
Pre-operative mean Hb value of the patients was 12.95±1.54 g/dL compared to a post-operative value of 11.01±1.25 g/dL.
When post-operative complications were classi ed by seriousness according to Clavien-Dindo classi cation, grade 1 complication [5.08%-urinary tract infection (UTI)] were noted in three patients and grade 2 complication were noted (3.38%-atelectasis) in two patients.

Discussion
Le Forte colpocleisis is not only an effective surgical treatment for POP patients but is also favorable for short operative time and low rates of associated complications and morbidity [10,11]. Colpocleisis is preferred in elderly and fragile patients who are no longer sexually active. In this study, we have compared POP-Q and GPFBQ scores as detected prior to surgery and 12 months after the surgery in the patients who underwent Le Forte colpocleisis in our department. Our analysis revealed statistically signi cant change in point C, TVL, and Gh measurements at post-operative month 12 compared to the pre-operative measurements as a result of surgery. Although these changes seem clinically insigni cant, this result may indicate anatomic recovery. Moreover, among GPFBQ, we have found statistically signi cant improvement in SUI, frequency, di culty in urination, and bulging of vagina which implies a positive impact on functional recovery.
Le Forte colpocleisis is mostly applied in elderly women. To this end, the mean age of 325 patients included in the study of Zebede and co-workers was 81.36±5.3 years, and likewise in the study by Reisenauer et al. 58 patients had a mean age of 81.9±6.4 years [4,12]. In our cohort, mean age was 71.67±7.01 years.
According to the literature, Le Forte colpocleisis features as a low-risk and well-tolerated surgery. The reasons for this are most possibly the ease of application as a surgical technique and the short operative time. A lot of publications reported for its intra-operative and post-operative complications. According to the review by FitzGerald and colleagues, post-operative cardiac, thromboembolic, pulmonary, and cerebrovascular complications were detected in almost 5% of the patients. On the other hand, approximately 15% of the patients had experienced minor complications including UTI, vaginal hematoma, cystotomy, fever, and thrombophlebitis [13]. Another study carried out by Hull sh et al. detected peri-operative complications in 18 out of 94 patients, most frequent of which was UTI experienced by four patients [14]. In our study, a major complication occurred only in one patient (2.56%) who developed atelectasia and a minor complication occurred in two patients (5.12%), both had UTI. The lower rates of major and minor complications attained in our study are most likely associated to the younger mean age in our sample.
POP-Q scoring system is one of the most widely used methods worldwide for the purposes of classi cation of and surgery success in POP [15]. Subsequent to a successful colpocleisis, POP-Q scores should improve remarkably. In their study of Reisenauer et al., POP-Q scores have been evaluated in 37 patients [12]. At the same study, mean measurement for TVL was 22±9 mm, for PB was 45±13 mm, and for Gh was 17±6 mm. In another study conducted by Fitzgerald M et al., TVL, Gh, and PB were evaluated pre-operatively and post-operatively [13]. In chronological order of their measurements, mean values for TVL were 9 cm and 3 cm; for Gh were 6 cm and 2 cm; and for PB were 3 cm and 4 cm. In our study preoperative vs. post-operative mean values for TVL were 8.93±1.73 mm vs. 35.1±12.4 mm, for Gh were 4.83±0.94 mm vs.4.26±0.94 mm, and for C point were 6.70±2.44 mm vs. -2.66±1.21 mm, respectively. We believe that the anatomical improvement in TVL is arising from the sutures placed in vertical axis and the improvement in C point is a result of vertical closure performed along the free edges of vaginal apex.
Along with the anatomical improvement, functional improvement is also essential following the POP surgery. Various questionnaires are often used to investigate this aspect, such as those on LUTS. In a study by Neimark et al, 45 women underwent Le forte colpoclesis, high perineoplasty and tension-free vaginal tape (TVT) [16]. When the pre-operative and post-operative 3 months results of these cases were evaluated; SUI and post-voiding residual symptoms were signi cantly decreased, constipation and irritative voiding symptoms did not change. In addition, the patients were administered the post-operative QoL questionnaires, but it is not possible to make a healthy evaluation because the questionnaire is not administered pre-operatively. In the study of Hull sh et al., patient queries were performed after an average of 2.75 years following the surgery [14]. Accordingly, 34 women who had pre-operative urgency and frequency symptoms who were asked whether they consider their condition had improved, two (5.9%) were not sure, one (2.9%) disagreed and remaining women were agreed. Furthermore, of the 34 women who had pre-operative di culty of emptying their bladder, four (11.8%) were not sure and another four (11.8%) disagreed. On the contrary to the Hull sh et al. 's study, our study did not provide a rank of options, but instead yes/no options for SUI, frequency, di culty of urination, and bulging of vagina improved by post-operative 12 month as stated by our respondents [14]. In addition to the difference in questionnaire methodology, compared to their results, our ndings also indicate a higher rate of patient satisfaction. Koski et al. have conducted Urinary Distress Inventory-6 on 21 women 9.3 months after on average Le Fort colpocleisis [17]. According to the answers provided by the respondents, 7 (%33.3) women had frequent urination and urge incontinence, 5 (23.8) women had SUI, 4 (19%) women had di culty in urinary leakage and di culty emptying. In the results of our study, 1 (%2.56) woman had frequent urination and, none of the women had urge incontinence and urinary leakage, 8 (20.51%) women had SUI, 2 (5.12%) women had di culty urination. The reason underlying the improvement in LUTS may be the anatomical elimination of anterior or posterior compartment defects.
SUI exerts adverse consequences on social life and physical activities of women, particularly those of advanced age. Its incidence varies by a number of factors with gures reported in the range of 16.1-68.8% [18]. The study by Fitzgerald and colleagues included 152 colpocleisis patients of whom 54% had preoperative SUI that reduced to 15% post-operatively [19]. Glavind et al. have investigated 40 patients for SUI of whom 17 (42.5%) had SUI at pre-operative period, while 7 (17.5%) patients have persisted and one (2.5%) patient had increased SUI during post-operative period [20]. In our patients, pre-operative SUI was detected in 51.28% while 20.51% had SUI at post-operative month 12. The results of the current study are comparable to the results documented in literature. Augmented support to the urethral neck is likely the reason for the improvement we detected in SUI. On the other hand, de novo SUI developed only in one patient.
The entire set of patients were operated in the same center by two surgeons experienced in their eld who also followed up the patients post-operatively. This altogether helped standardization of the study data. A strong aspect of this study is that it handles not only anatomic improvement but also improvement in LUTS. Nevertheless, it is limited by its single-center design and small sample size.

Conclusion
Le Fort colpocleisis features out as a surgery with a high rate of anatomical and functional success and low rate of complications preferable in elderly POP patients who are no longer sexually active. In addition to anatomical improvement, the improvement we have achieved in LUTS implies it also provides symptomatic recovery. In order to further demonstrate such recovery, studies with a larger sample size from different backgrounds are needed.

Declaration of competing interest
The authors have no con icts of interest relevant to this article.
The study was approved by the Ethics Committee of Muğla Sıtkı Koçman University Faculty of Medicine with a date and number of Jul 02, 2020, No:07/VI. The study was conducted according to the recommendations of Helsinki declaration. Written informed consent was obtained from all patients before undergoing surgery.

Consent for publications
Not applicable.

Financial Support
The funding sources had no involvement in any step of the manuscript.