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ORIGINAL ARTICLE
Year : 2023 | Volume
: 12
| Issue : 1 | Page : 38-43
Medium-term risk of recurrent pelvic organ prolapse within 2-year follow-up after laparoscopic sacrocolpopexy
Hirotaka Sato1, Shota Otsuka1, Hirokazu Abe2, Tomoaki Miyagawa3
1 Department of Urology, Hokusuikai Kinen Hospital, Mito, Japan
2 Department of Urology, Kameda Medical Center, Kamogawa, Japan
3 Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan
Correspondence Address:
Dr. Hirotaka Sato
Department of Urology, Hokusuikai Kinen Hospital, 3-2-1, Higashihara-Cyo, Mito-City, Ibaraki-Ken 310-0035
Japan
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/gmit.gmit_59_22
Objective: The present study was performed to determine the risk of recurrent pelvic organ prolapse (POP) within 2 years after laparoscopic sacrocolpopexy (LSC) in patients with uterovaginal prolapse.
Materials and Methods: A retrospective comparative study was performed in a population of 204 patients over a 2-year follow-up period following LSC with concomitant supracervical hysterectomy or uterine preservation at a single urological clinic between 2015 and 2019. The primary outcome was surgical failure following LSC in cases of POP, focusing on failures occurring before the 2nd year of follow-up. Logistic regression analysis was used to determine the odds ratios (ORs) for surgical failure.
Results: The primary outcome, surgical failure in cases of POP, occurred 2 years after the initial surgery in 19 of the 204 patients (9.3%) (95% confidence interval [CI], 5.7% – 14.2%). Surgical failure was most common in the anterior compartment (n = 10, 4.9%), and further surgery was performed in seven of the patients with surgical failure (3.4%). The poor primary outcome was predicted by lysis of adhesions (OR, 7.5, 95% CI, 1.6–33.8, P = 0.008) and preoperative POP stage IV (OR, 3.5; 95% CI, 1.1–10.8, P = 0.03) on multivariable logistic regression analysis.
Conclusion: The overall rate of surgical failure following LSC in our cohort was 9.3% over the 2-year follow-up period after surgery, and preoperative prolapse stage IV was associated with a higher risk of recurrence.
Keywords: Failure, pelvic organ prolapse, preoperative, risk factors
Pelvic organ prolapse (POP) is a common benign condition in women, the incidence of which is increasing with the aging of the population. Indeed, an approximately 50% increase in the incidence of POP has been projected by 2050,[1] and the current lifetime risk of undergoing surgery for POP was reported to be 11% by age 80 years in the USA.[2]
Although POP was reported to have a recurrence rate of 58% following vaginal repair,[3] the failure rates were based on composite outcomes and likely do not represent alleviation of symptoms. Sacrocolpopexy has been performed in such cases for more than a decade, and treatment of POP has been performed using prosthetic mesh to improve this high recurrence rate. Identification of risk factors for POP recurrence is crucial for the clinical management of these patients.[4] Patients should receive appropriate preoperative counseling to adjust their expectations and allow surgical treatment planning. Preoperative enlarged genital hiatus,[5],[6] concurrent anterior colporrhaphy,[6] preoperative advanced POP stage,[4] and younger age[7] have been reported to be risk factors for recurrence of POP following minimally invasive laparoscopic sacrocolpopexy (LSC).
Abdominal sacrocolpopexy (ASC) is the current gold standard transabdominal approach for the treatment of apical prolapse in otherwise healthy patients.[8] Although also technically challenging in some cases, the efficacy of LSC is equivalent to that of ASC, with reduced blood loss and shorter length of hospital stay after treatment.[9],[10] Recently, it has been reported that the short-term outcome of the novel modified form of using a vaginal-assisted laparoscopic hysterosacropexy are comparable to those of vaginal hysterectomy (VH) with vaginal vault suspension,[11] also short-term outcomes of laparoscopic hysterosacropexy and laparoscopic pectopexy with uterine preservation (UP) have reported to be comparable.[12] LSC has reported to have a lower long-term recurrence than VH or Manchester operation or colpocleisis.[13] However, the rates of recurrence of anterior vaginal prolapse and further surgery for posterior vaginal prolapse were reported to be higher in patients with UP treated with LSC than in ASC.[14]
The primary outcome in the present study was a surgical failure (anatomical failure) defined as POP Quantification (POP-Q) stage II or higher after the initial surgery, and secondary outcomes were factors associated with surgical failure within a 2-year follow-up period after LSC. Therefore, this study aims to determine the risk of recurrent POP within 2 years after LSC in patients with uterovaginal prolapse.
Materials and MethodsStudy design
Approval for the study protocol and consent for publication of this retrospective comparative study performed at a single urological clinic was provided by the Institutional Review Board (approval number: 2022–068). Clinical outcomes were assessed at 2 years after surgery in all cases.
Data collection
The medical records of consecutive patients undergoing LSC between August 2015 and February 2019 were reviewed, and their demographic characteristics, parity, body mass index (BMI), smoking status, comorbidities (e.g., diabetes mellitus, asthma, and constipation defined as fewer than three bowel movements every week for >6 months), previous abdominal and gynecological surgery, preoperative and postoperative POP-Q stage, operative time, estimated blood loss, concomitant surgical procedures, such as lysis of adhesions (LOA), bilateral salpingo-oophorectomy, and mesh placement site (single: Anterior vaginal wall; double: anterior and posterior vaginal wall) were determined. Patients >65 years old were defined as elderly. The patients were divided according to preoperative BMI into two groups, i.e., nonobese (BMI <30) and obese (BMI ≥30).[15] The inclusion criteria for this study were LSC with concomitant supracervical hysterectomy (SCH) or UP for preoperative POP-Q stage II or higher. The general stage of POP was defined as the most severe stage in one or more of the anterior, apical, and posterior vaginal compartments. Patients underwent diagnosis and physical examination for anatomical failure in the clinic with follow-up by a single surgeon (H. S.) at 1, 3, 6, 12, and 24 months and then annually thereafter. The POP was examined with a split speculum while the patient performed the Valsalva maneuver. Postoperative anatomical failure of POP was defined as POP-Q stage II or higher in at least one compartment. We performed a comparison of demographic, clinical, and surgical data, and patient-reported outcomes between patients with anatomical success and failure following LSC. Patients with previous hysterectomy were excluded from the study.
Surgical technique
All surgeries were conducted by a trained urologist (H. S.) according to our operative procedure, as reported previously.[16] Briefly, SCH or UP was selected based on the results of preoperative consultation with the patient and the patient's wishes after appropriate counseling. LSC was performed with anterior dissection to the level of the neck of the bladder and posterior dissection to the levator ani muscle. Polypropylene mesh (Gynemesh; Ethicon, Somerville, NJ) as either two separate sheets or a single Y-shaped sheet was sutured to the vagina using permanent nonabsorbable sutures (Tefdesser II; Kono Seisakusyo, Chiba, Japan). The sacral arm of the mesh was fixed to the anterior longitudinal ligament overlying the sacral promontory using permanent sutures. The surgical technique evolved during the study period, particularly with regard to the use of double or single mesh, with single mesh used in most cases. In addition, we used a concomitant mid-urethral sling procedure to minimize the occurrence of stress urinary incontinence.
Statistical analysis
Continuous variables are expressed as the mean ± standard deviation or median and interquartile range, while categorical variables are expressed as frequencies and percentages. The associations of categorical variables with the primary outcome, i.e., operative failure (e.g., surgical success and failure), and 95% confidence intervals (CIs) were calculated using the Chi-square test. The paired t-test and Student's t-test were used for the analysis of continuous data with a normal distribution, while the Mann–Whitney U-test was used for analysis of nonnormally distributed continuous data. The independent prognostic value of each variable associated with surgical failure was assessed by logistic regression analysis and odds ratio (ORs) with 95% CIs. Data were analyzed using EZR version 1.37 (Saitama Medical Center, Jichi Medical University, Saitama, Japan).[17] In all analyses, P < 0.05 was taken to indicate statistical significance.
ResultsThe study population consisted of 204 patients, of whom 19 (9.3%) showed anatomical failure with recurrence of POP during the 2-year follow-up period. The baseline demographic characteristics and preoperative values for all patients are summarized for the two groups in [Table 1]. A comparison between patients with surgical success and failure over the 2-year follow-up period is shown in [Table 1]. The diabetes mellitus rate was higher in patients with surgical failure than in those in whom surgery was successful. The percentage of failure in POP-Q stage 2 is 0%, stage 3, 11/149 (7.4%) and stage 4, 8/40 (20%). The rate of failures increased as the stage worsened. The perioperative details are shown in [Table 2]. There were no significant differences between the two groups in rates of single vs. double mesh placement sites (25.5% and 74.5%, respectively, in the whole cohort) or UP versus SCH (13.7% and 86.3%, respectively, in the whole cohort). In comparison to the surgical success group, the surgical failure group showed a similar rate of single mesh use (23.8% vs. 42.1%, respectively, P = 0.09), similar rate of double mesh use (76.2% vs. 57.9%, respectively, P = 0.09), a similar rate of UP (12.4% vs. 26.3%, respectively, P = 0.15), and a similar rate of SCH (87.6% vs. 73.7%, respectively, P = 0.15). The rate of LOA was 7.4% in the whole cohort, and was significantly higher in the surgical failure group than the surgical success group (26.3% vs. 5.4%, respectively, P = 0.007). With regard to POP-Q scores preoperatively and at 2 years postoperatively, all indices (Ba: most prolapsed portion of the anterior vaginal wall; Bp: most prolapsed portion of the posterior vaginal wall; C: leading edge of the cervix) except total vaginal length in the surgical success group showed significant differences in the direction of improvement [Table 3]. [Table 4] shows the postoperative involved compartments, mesh placement sites, and SCH or UP in the failure group. The rate of failure with stage II or greater POP at any compartment 2 years after the initial surgery was 9.3%, consisting of 10/204 (4.9%) with anterior prolapse, 6/204 (2.9%) with posterior prolapse, and 3/204 (1.5%) with apical prolapse. Postoperative anterior compartment failure occurred in 10 cases, consisting of 3/28 (10.7%) patients with UP and 7/176 (4.0%) patients with SCH. Posterior compartment failure occurred in six cases, consisting of 2/28 (7.1%) patients with UP and 4/176 (2.3%) patients with SCH. Postoperative apical compartment failure occurred in three patients, all of whom had been treated with SCH (3/176, 1.7%). There were no significant relations between compartments showing surgical failure and single/double mesh placement (P = 0.56) or SCH/UP (P = 0.64). Further surgery for recurrent POP during the study period was required in 7/204 (3.4%) patients in the whole cohort.
Table 3: Preoperative and postoperative pelvic organ prolapse quantification site measurements (cm) at 2 years
Table 4: Postoperative recurrent compartments, mesh placement site, and supracervical hysterectomy or uterine preservation in the pelvic organ prolapse surgical failure group n (%)The results indicated that LOA and preoperative POP-Q stage IV were independent predictors of recurrent POP over the 2-year follow-up period [Figure 1].
Figure 1: Multiple logistic regression analysis showing independent predictors of LSC failure. Error bars indicate 95% CI. BMI: Body mass index; BSO: Bilateral salpingo-oophorectomy; CI: Confidence interval; LOA: Lysis of adhesions, POP-Q: Pelvic organ prolapse quantification; LSC: Laparoscopic sacrocolpopexy Discussion The rate of operative failure within 2 years after LSC was 9.3% in this retrospective analysis, which was comparable to the rate of 9% reported in a previous review of studies with an average follow-up >1 year after minimally invasive LSC[18] but lower than the rate of 22% reported by Claerhout et al.[19] for a similar follow-up period and similar definition of anatomical failure as POP-Q stage II or higher at 2 years postoperatively. In our cohort, anterior compartment prolapse had the highest rate of 4.9%, followed by posterior compartment prolapse in 2.9% of cases, and apical compartment prolapse in 1.5% of cases. In contrast, Claerhout et al.[19] reported the highest rate of prolapse in the posterior compartment (18%), followed by the anterior compartment (3%) and apical compartment (2%). In addition, in a long-term (5 years) study of 82 patients using a similar definition of anatomical failure, Wagner et al.[20] reported that prolapse occurred in the posterior compartment in 18% of cases, followed by the anterior compartment in prolapse in 8.0% of cases and the apical compartment in 2.0% of cases. These discrepancies between our results and those of these previous studies were likely due to heterogeneity in the LSC techniques used,[21] for example, the types of mesh used, the sutures used to secure the mesh, and the sites of mesh placement, as well as differences in the concurrent surgeries performed between studies.
The anatomical results suggested that single or double reinforcement or SCH or UP selection alone may not be sufficient to explain surgical failures in cases with postoperative prolapse in each compartment. However, this study lacked statistical power to assess the impact of concomitant SCH or UP and double or single reinforcement. The percentage of cases with surgical failure in the anterior compartment was also higher in the subgroup with UP (10.7%) than in concomitant SCH (4.0%) in the present study. Our results with regard to anterior compartment failures were similar to those of Gagyor et al.,[22] who reported rates of 21.1% in cases undergoing UP and 8.8% in those undergoing SCH at 1 year postoperatively. Surgical failure in the posterior compartment was also more common in the UP subgroup (7.1%) than the SCH subgroup (2.3%) in our cohort, in contrast to the results of Gagyor et al.[22] who reported posterior compartment failure rates of 0% in the UP group and 15.8% in the SCH group. Our UP subgroup showed no cases of apical compartment failure too, which only occurred in the SCH subgroup (1.7%). Gagyor et al. reported no cases of apical failure,[22] and noted that anterior vaginal mesh insertion for UP is more technically challenging than hysterectomy with SCH. Based on the results of a systematic review including three randomized control studies, Ichikawa et al.[14] reported that POP recurrence was more common in the anterior compartment in patients without hysterectomy undergoing LSC with UP in comparison to ASC. They noted the relative technical difficulty of mesh insertion in UP compared to other types of LSC, and reported that the use of absorbable sutures for mesh fixation could result in mesh displacement, which could lead to recurrence due to the inability tensioning.
In the present study, the incidence of postoperative POP failure was high in patients with preoperative advanced stage (POP-Q stage IV). Padoa et al.[23] reported that preoperative POP-Q classification Ba >3 cm was associated with the risk of postoperative anterior compartment recurrence (POP-Q stage >2) in a retrospective study of robotic sacrocolpopexy. Advanced prolapse is likely to be associated with defects at all three levels of pelvic support,[24] and therefore, apical suspension procedures are likely to be of limited benefit in cases with more severe anterior vaginal prolapse. To achieve satisfactory anatomical results, it is necessary to shorten the anterior vaginal wall and address paravaginal defects.[23] It has also been suggested that addressing levels 2 and 3 at the same time as LSC may be advantageous in the treatment of advanced prolapse.[4]
LOA was shown to be a predictive factor for surgical failure with recurrence of POP in our cohort, as noted previously in studies of minimally invasive LSC[15] and robotic LSC.[25] This may be because most patients requiring LOA have a history of prior pelvic or abdominal surgery, making it difficult to dissect the vaginal wall due to adhesions and scar tissue leading to the anchoring of the mesh farther from the vaginal wall.
This study had some limitations, including its retrospective nature at a single center with a relatively small sample size. There may also have been measurement bias as physical examinations were performed by a single surgeon and was an objective outcome measure consisting of heterogeneity of LSC techniques used. This may be alleviated in future studies by having urogynecologists who are not involved in the initial surgery perform the physical examinations, but this was not possible in the present study due to the small number of physicians at our institution. In addition, 2-year follow-up data represent only medium-term outcomes, and further studies are required to examine outcomes over the longer term. Another limitation of this study was that the definition of failure incorporated only anatomical measures of pelvic support and not the subjective definition of the patient. There is as yet no consensus regarding the definition of success after POP surgery. A similar study defined the POP recurrence cutoff point as beyond the hymen[26] although anterior and posterior vaginal locations at or around the hymen (POP-Q stage II) are acceptable surgical outcomes, most surgeons will not accept the vaginal apex being located a few centimeters above the hymen, even if the patient experiences symptom relief.[3] Therefore, the failure cutoff point was set at POP-Q stage II. However, we feel that 2 years postoperatively is an appropriate time point for the measurement of objective outcomes, as data regarding such outcomes after LSC are limited, and there is still controversy regarding appropriate predictive factors associated with surgical failure in cases of POP. A major strength of this study is that all objective outcomes of the patients during the study period were included in the analysis.
ConclusionThis study showed that LSC is associated with a higher rate of anterior surgical failure in cases of POP in women with uterovaginal prolapse. Anterior compartment surgical failure occurred more frequently in the UP subgroup than in the SCH subgroup. More robust data collection is required to confirm this finding. POP-Q stage IV and concomitant LOA were also shown to be risk factors for postoperative surgical failure in cases of POP. These observations can be used to provide appropriate preoperative counseling to patients.
Acknowledgments
The authors would like to thank Dolphin Corporation for the English language review.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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