We aim to assess the surgical outcomes of our novel hysteropexy procedure, laparoscopic long mesh surgery (LLMS) with augmented round ligaments. Twenty-five consecutive women with stage II or greater main uterine prolapse defined by the POP quantification staging system were referred for LLMS. Long mesh is a synthetic T-shaped mesh, with the body fixed at the uterine cervix and the two arms fixed along the bilateral round ligaments. The clinical evaluations performed before and 6 months after surgery included pelvic examinations, urodynamic studies, and questionnaires for urinary and sexual symptoms. After a follow-up time of 12 to 24 months, the anatomical reduction rate was 92% (23/25) for the apical compartment. The average operative time was 65.4 ± 28.8 minutes. No major complications were recognized during LLMS. The lower urinary tract symptoms and scores on the questionnaires improved significantly after the surgery, except urgency urinary incontinence and nocturia. Neither voiding nor storage dysfunction was observed after the operations. All of the domains and total Female Sexual Function Index (FSFI) scores of the 15 sexually active women did not differ significantly after LLMS. The results of our study suggest that LLMS is an effective, safe, and time-saving hysteropexy surgery for the treatment of apical prolapse.
These authors contributed equally: Cheng-Yu Long and Chiu-Lin Wang.
Pelvic organ prolapse (POP) refers to the downward displacement of pelvic organs[
We started to perform laparoscopic organopexy with non-mesh genital (LONG) suspension in 2014, as an innovative method for treating uterine prolapse in women who wish to preserve their uteri[
Despite the favorable outcome, some skepticism has been raised regarding the durability of suspension power based solely on the adhesion between the transverse fascia beneath the rectus abdominis muscle and the uterus. Other concerns include the long-term effects of the untreated anterior or posterior compartment and the impacts on subsequent hysterectomy, if needed. Studies with longer follow-up durations are ongoing in order to answer these questions. In addition, we have advanced the search for new solutions with our laparoscopic long mesh surgery (LLMS) with augmented round ligaments.
Although sacrocolpopexy has been considered the gold-standard procedure for the treatment of apical prolapse, the long operation time and steep learning curve have restricted its popularity[
LLMS with augmented round ligaments was designed to create ventral uterine suspension by anchoring the mesh to the cervix and round ligaments. Our study aimed to assess whether this new procedure was effective, safe, and time-saving. In addition, the surgical complications and functional outcomes were also evaluated.
Of the 25 women undergoing LLMS with augmented round ligaments, 23 (92%) had a successful anatomic correction in the apical compartment without any major complications during the 12–24 month follow-up.
The baseline demographic data were obtained in the 25 women, including age, parity, body mass index (BMI), menopausal status, number under hormone therapy, underlying disease, baseline POP stage, concomitant procedures and follow-up period, as shown in Table 1. The mean age of our study population was 55.3 years old, and the mean parity was 1.9. Eleven (44%) women had stage 2 apical prolapse, and 14 (56%) had stage 3 apical prolapse. Fifty-two percent of women had prolapse in multiple compartments. Except for the unchanged total vaginal length (9 (9~11) vs. 9 (9~10), p = 0.52), other POP quantification (POP-Q) measurements before and after the surgeries all revealed statistically significant differences (Table 2). There were 2 (8%) cases of apical prolapse recurrence and 1 (4%) case of anterior compartment prolapse recurrence after surgery. One woman suffered from both anterior and apical prolapse, and the other woman had apical prolapse alone postoperatively; the original POP stages of these 2 women were stage 3 and 2, respectively.
Demographic characteristics of the women who received laparoscopic long mesh surgery with augmented round ligaments (n = 25).
Parameters mean± SD n (%) Age (years) 55.3 ± 10.8 Parity 1.9 ± 0.5 BMI (kg/m2) 24.0 ± 3.2 Menopause 17 (68) Current hormone therapy 1 (4) Diabetes mellitus 1 (4) Hypertension 8 (32) Baseline apical stage II POP 11 (44) with anterior stage II POP 4 (16) with anterior stage III POP 3 (12) with posterior stage II POP 1 (4) Baseline apical stage III POP 14 (56) with anterior stage III POP 3 (12) with posterior stage II POP 2 (8) Concomitant procedures in this study Anterior colporrhaphy 3 (12) Posterior colporrhaphy 3 (12) Cervical amputation 9 (36) Myomectomy 2 (8) Midurethral sling 3 (12) Follow-up (months) 12–24
Pelvic organ prolapse quantification (POP-Q) values before and after surgery.
POP-Q parameters Preoperative (n = 25) Postoperative (n = 25) Aa 0 (−3~1.5) −2 (−3~−1) <0.001 Ba 2.5 (−0~3) −2 (−3~−1) <0.001 C 2.5 (−3~3) −8 (−6~−10) <0.001 Ap −2 (−3~−2) −3 (−3~−2) 0.030 Bp 1 (−3~2) −2 (−3~−1) 0.002 TvL 9 (9~11) 9 (9~10) 0.521 Recurrent POP Apical prolapse 2 (8) Anterior vaginal prolapse 1 (4) Posterior vaginal prolapse 0
In terms of lower urinary tract symptoms (LUTS), many factors significantly improved after LLMS, including urinary frequency (36% vs. 4%, p = 0.021), stress urinary incontinence (SUI) (80% vs. 24%, p < 0.001), feeling of incomplete emptying (56% vs. 8%, p < 0.001), and hesitancy (52% vs. 16%, p = 0.004) (Table 3). The scores of the questionnaires, including the Overactive Bladder Symptom Score (OABSS) and the short forms of the Urogenital Distress Inventory (UDI-6), the Incontinence Impact Questionnaire (IIQ-7), and the Pelvic Organ Prolapse Distress Inventory (POPDI-6), all improved significantly after the operations, as shown in Table 3. The urodynamic study revealed that none of the participants had voiding or storage dysfunction after the surgeries; furthermore, the amount of residual urine decreased significantly in the urodynamic parameter analysis, as shown in Table 4. Of the 15 women who remained sexually active before the operation, the Female Sexual Function Index (FSFI) did not differ significantly for each item or in terms of the total scores pre- and post-operatively (Table 5).
Urinary symptoms and quality of life questionnaires before and 6 months after surgery.
Symptoms Preoperative (n = 25) Postoperative (n = 25) Urinary frequency 9 (36) 1 (4) 0.021*** Stress urinary incontinence 20 (80) 6 (24) <0.001*** Urgency urinary incontinence 6 (24) 2 (8) 0.22 *** Feeling of incomplete bladder emptying 14 (56) 2 (8) <0.001*** Hesitancy 13 (52) 4 (16) 0.004*** Nocturia 18 (72) 13 (52) 0.27 *** OABSS 4.8 ± 3.3 3.9 ± 1.8 0.004*** UDI-6 25.1 ± 16.8 14.4 ± 6.8 0.009*** IIQ-7 32.4 ± 24.3 13.3 ± 12.8 <0.001*** POPDI-6 9.2 ± 4.8 5.5 ± 3.0 <0.001***
Urodynamic changes before and 6 months after surgery.
Parameters Preoperative (n = 25) Postoperative (n = 25) Qmax (mL/s) 19.4 ± 6.7 18.8 ± 4.0 0.71** RU (mL) 31.0 ± 14.5 11.2 ± 5.7 0.006** DO 8 (32) 3 (12) 0.70** FS (mL) 157.7 ± 49.5 154.5 ± 62.3 0.63** MCC (mL) 287.2 ± 79.4 311.0 ± 59.5 0.07** PdetQmax (cmH2O) 24.5 ± 12.9 23.0 ± 15.9 0.52** FUL (mm) 28.4 ± 5.4 29.4 ± 6.8 0.82** MUCP (cmH2O) 52.3 ± 21.2 54.1 ± 20.7 0.75**
Changes in scores of the Female Sexual Function Index before and 6 months after surgery.
Parameters Preoperative (n = 15) Postoperative (n = 15) Sexual desire 3.5 ± 0.5 3.6 ± 0.8 0.77 Sexual arousal 3.9 ± 0.9 3.8 ± 0.6 0.48 Lubrication 4.5 ± 0.8 4.1 ± 1.3 0.27 Orgasm 4.7 ± 0.9 4.3 ± 0.5 0.12 Satisfaction 4.8 ± 0.9 4.9 ± 0.8 0.16 Dyspareunia 4.9 ± 1.3 4.1 ± 1.3 0.12 Total scores 26.3 ± 4.6 24.8 ± 3.0 0.19
The operative time of all women was 65.4 ± 28.8 minutes, and no intraoperative complications were noted (Table 6). The postoperative surgical wound pain was tolerable. Three of the 25 participants experienced urinary tract infection after surgery, and all of them were treated with oral cephradine (Unifradine
Intraoperative and postoperative complications.
n = 25 Clavien-Dindo Classification Operative time (minutes) 65.4 ± 28.8 Intraoperative complications Bladder injury 0 Rectal injury 0 Blood transfusion 0 Conversion to open surgery 0 Postoperative complications Postoperative day 1 VAS score 2.1 ± 1.5 Grade I Urinary tract infection 3 (12) Grade II Voiding dysfunction 0 Pelvic hematoma 0
LLMS with augmented round ligaments is a novel surgical method for apical prolapse with a high anatomical reduction rate, short operation time, and low complication rate in women with dominant apical prolapse who prefer uterine preservation in their POP surgeries. Concomitant anterior and/or posterior colporrhaphy may sometimes be needed in multi-compartment POP.
TVM surgeries have become popular in the last several years due to the favorable surgical outcomes and the easy approach, regardless of hysteropexy or hysterectomy surgeries[
In a Cochrane review, compared with a variety of vaginal interventions, sacrocolpopexy or sacrohysteropexy was demonstrated to be associated with a lower risk of subjective or objective prolapse recurrence, repeat surgery for prolapse, postoperative SUI and dyspareunia, serving as the gold standard for apical prolapse[
LLMS has the advantage of being a minimally invasive approach without the disadvantages associated with sacrocolpopexy, such as the long operation time and the possibility of severe complications. It results in a high success rate of anatomic reduction during a follow-up of 1–2 years. The dissection method of LLMS is similar to that of ventral suspension in pectopexy, which fixes the descending organ to the iliopectineal ligaments using polyvinylidene fluoride monofilament mesh[
In LLMS with augmented round ligaments, the operation field is relatively safe and easily approached for surgeons. Additionally, the mesh is pulled out of the skin from the abdominal wound medial to the anterior superior iliac spine (ASIS), providing an easy intraoperative tension adjustment mechanism, either tighter or looser. The uterus can reach an appropriate position with an adequate total vaginal length. Most importantly, the barbed sutures between the bilateral round ligaments and mesh can enhance tissue reaction and fibrosis, making the surgical outcome more robust. The round ligaments can also be folded to an ideal length during suturing if they are too long due to the stretching by descending organs, making tissue remodeling even better. This approach is very different from laparoscopic pectopexy or other types of lateral suspension using mesh, simply creating a new "mesh" ligament without augmentation of the original round ligament[
Female sexual dysfunction is common among women with urogynecological conditions[
The results regarding the urodynamic parameters revealed no voiding or storage function disturbances after surgery. The amount of residual urine also decreased significantly after successful anatomic reduction. LLMS significantly improved most of the LUTS, except for urgency urinary incontinence and nocturia. The urodynamic study results also revealed no significant decrease in the detrusor overactivity (DO) rate. The findings described above suggest that even though LLMS provides fair anatomical reduction, concomitant medical treatment is sometimes needed for the treatment of urgency urinary incontinence and nocturia in these patients. Women with urgency urinary incontinence, or overactive bladder (OAB)-wet, have a small bladder capacity and poor urethral closing mechanism and are usually treated with antimuscarinic agents[
The horizontal traction level between S1 and S2 in LLMS is similar to that in pectopexy. This anchor point is appropriate for the physiological axis of the vagina, and no de novo defecation symptoms were observed after pectopexy[
LLMS is a safe procedure, as the only complication observed in our study was UTI. There were 2 cases of recurrence in our study, occurring in the second and 5th cases. This can be explained by the fact that a learning curve still exists for this novel procedure. Due to the small number of cases of recurrence, our data are insufficient for addressing the patient characteristics regarding the risk of recurrence. For these 2 cases, we then further performed vaginal hysterectomy and sacrospinous ligament fixation to solve the problem of recurrent POP. Among all the cases of recurrent POP, vaginal vault prolapse was the most difficult to manage. Studies have provided strategies for prevention[
The preliminary data for LLMS suggests that this procedure meets the needs of the increasing requests for uterine preservation, as it is a minimally invasive POP surgery with a high anatomical reduction rate, a short operation time, and few major intraoperative complications, although further studies with larger sample sizes should be conducted to make these results more robust. This procedure has the advantage of synthetic mesh durability while minimizing the concern for internal organ injury by being completely concealed under the peritoneum. It avoids the possible major complications associated with laparoscopic sacrocolpopexy; it solves the concerns regarding the seemingly compressed urinary bladder as well as subsequent hysterectomy concerns of LONG surgery. The study of long-term efficacy is ongoing and promising.
There is no doubt that the flaws of our study are the limited number of cases and the short follow-up period. In terms of mesh surgeries, a two-year follow-up sometimes cannot reveal all the complications and durability. Long-term follow-up results of stitch and mesh extrusion after sacrocolpopexy have been reported[
From August 2017 through November 2018, 36 consecutive women with mainly stage II or greater uterine prolapse as defined by the POP-Q staging system[
Graph: Figure 1 The clinical trial flowchart for laparoscopic long mesh surgery with augmented round ligaments.
All surgical procedures were performed under general anesthesia. Every patient received a single dose of intravenous prophylactic antibiotics. The patients were placed in a lithotomy position. Laparoscopy was set up with the endoscope located at the 10-mm umbilical wound, two 5-mm trocar ports in the bilateral lower quadrant of the abdomen (2 cm medial to the anterior superior iliac spine), and one 5-mm trocar port 8 cm left and lateral to the umbilicus. The peritoneum at the utero-vesical fold was dissected to expose the anterior colpo-cervical junction. Long mesh, a synthetic T-shaped mesh (Fig. 2, Gynemsh, Ethicon, San Lorenzo, Puerto Rico), was delivered into the pelvic cavity (Fig. 3A). Bilateral mesh arms were extracted outside the trocar wounds bilaterally to stabilize the mesh position. The center piece was fixed to the cervix with 5-mm ProTack screws (Covidien, New Haven, Connecticut) (Fig. 3B). Fixation was strengthened with Stratafix 2–0 sutures (Ethicon, Norderstedt, Germany) (Fig. 3B), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among the surrounding tissues. An extraperitoneal tunnel was created along the left round ligament until it reached a location 2 cm medial to ASIS. One arm of the long mesh was pulled out along the tunnel underneath the round ligament and fixed with the fascia of the abdominal oblique muscle. The same procedure was repeated on the contralateral side. The bilateral round ligaments and the mesh arms were sutured continuously with Stratafix 2–0 (Fig. 3C). Reperitonealization was carried out thereafter (Fig. 3D). The tension of the mesh was adjusted until the apical compartment was reduced to an appropriate position per the vaginal examination (Fig. 3E).
Graph: Figure 2 The parameters and design of the long mesh.
Graph: Figure 3 The procedural process. (A) Under laparoscopy, the peritoneum of the utero-vesical fold was dissected to expose the anterior colpo-cervical junction. T-shaped self-tailored long mesh was delivered to the operation field. Bilateral mesh legs were extracted outside the trocar wounds to stabilize the mesh position. (B) Center piece of the mesh was fixed to the cervix with ProTack screws (Covidien, New Haven, Connecticut), Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany) and Tisseel fibrin sealant (Baxter, Deerfield Illinois). (C) Bilateral round ligaments and the mesh arms were sutured continuously with Stratafix 2-0. (D) Reperitonealization with the remaining Stratafix 2-0 sutures. (E) The tension of the mesh was adjusted until the cervix was reduced to the deepest point according to the vaginal examination.
The baseline demographic data included age, parity, body mass index (BMI), menopausal status, number under hormone therapy, underlying disease, baseline POP stage, concomitant procedures and follow-up period. The clinical evaluations consisted of a detailed history before and 6 months after surgery, including urinary analysis, pelvic examination using the POP-Q system[
The primary outcome of this study was the degree of anatomical reduction after the surgery as assessed by pelvic examination using the POP-Q system. Regarding the secondary outcomes, LUTS and sexual function were assessed with the questionnaires listed above, and storage and voiding function was evaluated by UDS 6 months after the surgery. For follow-up, postoperative outpatient visits were conducted at 1, 2, 3, 6, and 12 months and then semiannually beyond one year. A pelvic examination was performed routinely during every visit to the clinic. Recurrence was defined as the most dependent portion of stage II or greater POP in the anterior, apical and posterior compartments. Clavien-Dindo grading was used for the classification of the intraoperative and postoperative complications of LLMS[
We assessed the power of tests for differentiating the surgical outcomes of the LLMS procedure, and power analysis showed that approximately 25–30 women in this study would have a power of 80% and a 5% significance level in this one-tail test. Expecting a withdrawal rate of 20%, we enrolled a total of 36 women for this study. Although some comparisons, such as the rate of DO, could not reach sufficient power due to the limited number of patients, we utilized multiple parameters of the POP-Q system to evaluate postoperative changes. We found that for our 24 female subjects, there would be a power of over 82% for discrimination.
IBM SPSS Statistical Software version 20.0 ed. was used for the statistical analyses. The Wilcoxon signed-rank test was performed for comparison between preoperative and postoperative POP-Q parameters. McNemar's and Fisher's exact tests were performed for categorical variables. Paired t-tests were performed for two related units on a continuous outcome. A p-value of less than 0.05 was considered statistically significant.
This study received approval from the Institutional Review Board of Kaohsiung Medical University Hospital (ID: KMUHIRB-E(I)-20190015), by which relevant guidelines and regulations were followed accordingly. This study was also registered at ClinicalTrials.gov (ID: NCT04139083, registered on 25/10/2019).
Informed consent was obtained from all participants before the surgeries.
LLMS with augmented round ligaments is a novel surgical method for women with apical prolapse and a desire for uterine preservation. It provides not only anatomic correction of POP but also improvements in LUTS and quality of life. The short-term follow-up results of the surgery showed it has a high efficacy, is time-saving, and has a relatively low complication rate for women with main apical prolapse. Concomitant anterior and/or posterior colporrhaphy may sometimes be needed in multi-compartment POP.
We would like to thank Ministry of Health and Welfare (MOHW107-TDU-B-212-123006), Kaohsiung Medical University Hospital (KMU-TC108A02-7), and Kaohsiung Municipal Siaogang Hospital (K-107-24) for financially supporting the work.
C.Y. Long developed the protocol and worked on editing the manuscript. C.L. Wang, K.L. Lin, C.R. Ker, Z. Loo, and Y. Liu took part in the operations and were in charge of data collection and analysis. C.R. Ker contributed to English editing. P.C. Wu wrote the main text of the manuscript. All authors reviewed the manuscript.
The datasets analyzed during the current study are available from the corresponding author upon reasonable request.
The authors declare no competing interests.
Graph: Clinical Study Protocol.
is available for this paper at 10.1038/s41598-020-63725-x.
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By Cheng-Yu Long; Chiu-Lin Wang; Kun-Ling Lin; Chin-Ru Ker; Zixi Loo; Yiyin Liu and Pei-Chi Wu
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