Results of sacrospinous ligament fixation using conventional instruments for symptomatic stage 2 and 3 apical prolapse over 3 years.

OBJECTIVE: To evaluate the long-term efficacy and quality of life concerning sacrospinous ligament fixation (SSLF) using conventional instruments for Chinese women with symptomatic stage 2 and 3 apical prolapse. METHODS: This single-arm prospective cohort study was conducted at our hospital between October 2011 and December 2018. Eligible participants were followed up over 3 years after surgery. The primary surgical outcome was composite surgical failure. Secondary outcomes included rate of satisfaction, quality of life (QoL) scores, and long-term complications. RESULTS: Fifty-nine patients were enrolled (mean age 57.1 years), of whom 55 (93.22%) completed the 3-year follow up. At year 3, the composite failure rate was 21.34% (95% confidence interval [CI] 9.30%-31.79%), and satisfaction rate was 81.40% (95% CI 66.09%-91.08%). Right thigh pain and de novo dyspareunia occurred in 1.8% and 14.6% patients after year 1, respectively, but at year 3 there were no complications. Lower urinary tract symptoms were present in 5.5% of patients. Improvement was found in urinary symptoms and prolapse symptoms, but sexual function showed no significant change. CONCLUSIONS: Compared with results at year 1, complication rates of SSLF decreased at year 3. The composite failure rate was relatively low and satisfaction rate was relatively high at year 3. Prolapse and urinary symptoms improved significantly after surgery.

Current situation of complications related to reconstructive surgery for pelvic organ prolapse: a multicenter study.

INTRODUCTION AND HYPOTHESIS: This study aimed to investigate the evaluation and management of complications after pelvic floor reconstructive surgery for pelvic organ prolapse in China. METHODS: Complications of pelvic floor reconstructive surgery for pelvic organ prolapses from 27 institutions were reported from November 2017 to October 2019. All complications were coded according to the category-time-site system proposed by the International Urogynecological Association (IUGA) and the International Continence Society (ICS). The severity of the complications was graded by the Clavien-Dindo grading system. Four scales were used to evaluate patient satisfaction and quality of life after management of the complications: the Patient Global Impression of Improvement (PGI-I), the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7), the Pelvic Organ Prolapse Symptom Score (POP-SS), and a 5-point Likert-type scale that evaluated the patient's choice of surgery. RESULTS: Totally, 256 cases were reported. The occurrence of complications related to transvaginal mesh (TVM) and laparoscopic sacrocolpopexy (LSC) had a significantly longer post-surgery delay than those of native tissue repair surgery (p < 0.001 and p = 0.010, respectively). Both PFIQ-7 and POP-SS score were lower after management of complications (p < 0.001). Most respondents (81.67%) selected very much better, much better, or a little better on the PGI-I scale. Only 13.3% respondents selected unlikely or highly unlikely on the 5-point Likert-type scale. CONCLUSIONS: The occurrence of complications related to TVM surgery and LSC had a longer post-surgery delay than native tissue repair surgery. Long-term regular follow-up was vital in complication management. Patient satisfaction with the management of TVM complications was acceptable.

A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse.

BACKGROUND: It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011. METHODS: A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided). RESULTS: The number of different procedures during October 1, 2011-September 30, 2018 was more than twice that during October 1, 2004-September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004-September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011-September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107). CONCLUSIONS: The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly. TRIAL REGISTRATION NUMBER: NCT03620565, https://register.clinicaltrials.gov.

Evaluation of extracellular matrix protein expression and apoptosis in the uterosacral ligaments of patients with or without pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: This study aimed to compare the expression levels of extracellular matrix (ECM) and apoptosis proteins in the uterosacral ligament (USL) of patients with and without pelvic organ prolapse (POP). METHODS: The USL were obtained from patients with POP-Q ≥ III (n = 35) and without POP (n = 20). Immunohistochemistry (IHC) staining and RT-qPCR were conducted to assess the protein and mRNA levels, respectively. The levels of type I collagen (COLI), type III collagen (COLIII), matrix metalloproteinase (MMP)1, MMP2, MMP9, tissue inhibitor of metalloproteinase (TIMP)1, TIMP2, estrogen receptor (ER)α, ERß and apoptosis-related gene B cell lymphoma 2 (Bcl-2)-associated agonist of cell death (Bad) and Bcl-2-associated X (Bax) in the USL were analyzed. RESULTS: The protein expression and mRNA levels of MMP2 and MMP9, mRNA levels of BAD and BAX, and protein expression of active cleaved-Caspase3 were significantly higher in the POP group. There were no evident differences in COLIII, MMP1 or ERß expression at either the mRNA or protein level or in TIMP1, TIMP2 or Caspase3 by IHC between the two groups. However, obvious decreases in COLI and ERα were evident at both the mRNA and protein levels in the POP group, and the mRNA levels of TIMP1 and TIMP2 were also decreased compared to those of the control group. CONCLUSION: ECM in the USL tissues of POP patients is remodeled compared with non-POP patients and is characterized by decreased synthesis and increased degradation of collagen; moreover, the levels of the main proteins involved in apoptosis are increased in POP tissue.

Trocar-site hernia after gynecological laparoscopic surgery: a 20-year, single-center experience.

BACKGROUND: Trocar-site hernia (TSH) is a serious complication after laparoscopic procedures. Although it is a rare entity, it can have life-threatening consequences. This study aimed to retrospectively analyze the potential associated factors for TSH following gynecologic laparoscopy and summarize prevention strategies based on our experience. METHODS: We searched for gynecological laparoscopic surgeries in the medical records system of Peking Union Medical College Hospital (PUMCH) from August 1998 to July 2018 and further sifted through the results for cases involving TSH. All included patients were divided into different groups according to patient characteristics, and the rate of TSH was compared among groups. Moreover, the detailed information of all patients with TSH was recorded and analyzed. Statistical analyses were performed with GraphPad Prism 6. RESULTS: The approximate total rate of post-operative TSH among gynecologic laparoscopy procedures performed at PUMCH in the last 20 years was 0.016% (9/55,244). The rate of TSH was significant higher in elder patients (≥60 years old; 3/2686, 0.112%) than in younger patients (<60 years old, 6/52,558; 0.011%, P = 0.008). Moreover, the approximate rate of TSH was significantly higher after single-incision laparoscopic surgery (SILS, 2/534, 0.357%) than conventional laparoscopic surgery (7/54,710, 0.013%, P = 0.003). The average age of patients with TSH was 53.4 years (range, 35.0-79.0 years). Two of the nine patients had late-onset TSH following SILS; the other seven had early-onset TSH following conventional laparoscopy. Five TSH cases occurred at right lateral port sites, and the remaining three occurred at the umbilical port site. All patients underwent repair surgery, and one required small bowel resection. CONCLUSION: Older age and SILS are potential associated factors for TSH development, while reducing excessive manipulation and improving suturing skills, especially at the umbilical trocar site following SILS and the right lateral trocar site, can avoid herniation.

Proteomic Analysis of the Uterosacral Ligament in Postmenopausal Women with and without Pelvic Organ Prolapse.

BACKGROUND: Pelvic organ prolapse (POP) is a major health problem in adult women that involves many factors. No proteomic analysis has been conducted exclusively in POP patients. This study aimed to identify the differential expression of proteins that may be involved in POP by proteomic analysis. METHODS: Samples of the uterosacral ligament (USL) were collected from five POP patients and five non-POP patients matched according to age, parity, and menopausal status and analyzed using two-dimensional electrophoresis and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS). Quantitative real-time polymerase chain reaction (qRT-PCR) was used to verify the mRNA expression of proteins that showed differential expression in the proteomic analyses. RESULTS: Proteins differentially expressed between POP and non-POP patients were detected. Eight proteins that were down-regulated in the POP group were identified by MALDI-TOF-MS. These proteins included electron transfer flavoprotein, apolipoprotein A-I, actin, transgelin, cofilin-1, cyclophilin A, myosin, and galectin-1, and their expression was verified by qRT-PCR. CONCLUSION: Using comparative proteomics, we identified eight differentially expressed proteins (including four cytoskeleton proteins and three proteins related to apoptosis) in the USL that may be involved in apoptosis associated with the tissue effects in POP pathophysiology.

Manometric comparison of anorectal function after posterior vaginal compartment repair with and without mesh.

BACKGROUND: Although repair augmented with mesh has been proved its priority in anatomical and functional recovery after anterior compartment reconstruction, the data about posterior compartment are scarce. The aim of this study was to compare bowel functional outcome of posterior vaginal compartment repair with and without mesh in patients with pelvic organ prolapse (POP). METHODS: This was a prospective, double-blind, clinical pilot study of 22 postmenopausal women with symptomatic POP (overall POP-quantification [POP-Q] Stage III-IV) who underwent total pelvic floor reconstruction. Patients were grouped according to the use of mesh for posterior vaginal compartment repair: A mesh group and a nonmesh group. POP-Q stage, the pelvic floor impact questionnaire short form-7 (PFIQ-7) and anorectal manometry were evaluated before and 3 months after surgery. Anatomical success was defined as POP-Q Stage II or less. A t-test was used to compare preoperative with postoperative data in the two groups. RESULTS: Totally, 17 (71%) were available for the follow-up. POP-Q measurements improved significantly compared to baseline (P < 0.05) in both groups. No recurrence was observed. Subjects in both groups reported improvement in pelvic floor symptoms, and there was no significant difference in the PFIQ-7 score between groups at follow-up (P > 0.05). Compared with baseline, the nonmesh group exhibited a statistically significant decrease in anal residual pressure, a significant increase in the anorectal pressure difference during bowel movement, and a reduced rate of dyssynergia defecation pattern (P < 0.05). CONCLUSIONS: Provided there is sufficient support for the anterior wall and apex of vagina with mesh, posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal motor function.

[Study on ischiospinous ligament fixation in treatment of stage III pelvic organ prolapse].

OBJECTIVE: To evaluate the safety and efficacy of ischiospinous ligament fixation in treatment of stage III pelvic organ prolapse (POP). METHODS: Between March 2007 and December 2009, 65 patients with stage III POP who underwent ischiospinous ligament fixation in Peking Union Medical College Hospital were enrolled in this study. Among 21 cases complicated with stress urinary incontinence (SUI) underwent transobturator tension-free vaginal tape (TVT-O) concomitantly. Clinical parameter associated with perioperation, objective and subjective successful rate and complication were recorded. RESULTS: The mean operating time was (71 ± 22) min and the mean blood loss was (93 ± 40) ml. No intraoperative blood transfusion and viscera injury cases were observed. All patients were able to recover spontaneous micturition. Two cases experienced pelvic hematoma with diameter of 7 cm, after conservative treatment, they all recovered later. The objective success rate was 100% at 6 weeks follow-up by POP-Q scoring. And 46.2% (30/65) were followed up at range of 1 - 3 years, recurrence rate were 10% (3/30), and however, no operation were needed. At median of 20 months, all patients were followed up by telephone, the subjective successful rate was 95.4% (62/65). At 6 weeks after operation, 6.2% (4/65) patients suffered from lower back pain and right thigh pain, visual analogue scale of pain was at range of 3 to 5, which relieved gradually after treatment and disappeared totally within 2 years. The rate of suture exposure was 10% (3/30), the new urinary incontinence 4.6% (3/65), and the new dyspareunia 12.5% (3/24). CONCLUSIONS: Ischiospinous ligament fixation is a safe and efficacious management.

[Prospective study on total pelvic reconstruction surgery with Prosima in the treatment of pelvic organ prolapse stage III].

OBJECTIVE: To evaluate the safety and efficacy of total pelvic reconstruction surgery with Prosima in treatment of pelvic organ prolapse (POP) stage III. METHODS: From July 2010 to December 2011, 31 patients with POP stage III undergoing total pelvic reconstruction surgery with Prosima were enrolled in this prospective study. Among two cases complicated with stress urinary incontinence underwent transobturator tension-free vaginal tape concomitantly with total pelvic reconstruction surgery with Prosima. Clinical parameters during peri-operation were recorded and compared. Pelvic organ prolapse quantitative examination (POP-Q) and anatomic improvement in these patients after surgery were analyzed. Comparisons of pelvic floor impact questionnaire-short form 7 (PFIQ-7) and pelvic organ prolapse-urinary incontinence sexual questionnaire-short form 12 (PISQ-12) in these patients before and after surgery were used to evaluate quality of life and quality of sexual life. RESULTS: The mean operating time was (55 ± 13) minutes, mean blood loss was (66 ± 25) ml. No severe intraoperative complications were observed. All patients were able to recover spontaneous micturation within 5 days. Two cases experienced pelvic hematoma with diameters less than 7 cm, and resolved later. Another case was urinary tract infection. At the median follow-up 6 months (1 - 15 months), the rate of anatomic success defined as the leading vaginal edge above the hymen was 94% (29/31). There were significant improvements in Aa, Ba, Ap, Bp, and C (P < 0.01) by POP-Q. Two patients showed recurrent prolapse at 3 months and 1 year after surgery, without the need of further operation. The median score of post-operative PFIQ-7 was 0 point at 6 months and 0 point at 12 months after operation, respectively, which were significantly lower than that of 50 points pre-operation (P < 0.01). And there was no significant difference in the average score of PISQ-12 before and after surgery [(30 ± 6) points versus (31 ± 4) points] (P > 0.05). The rate of mesh exposure was 16% (5/31), all the 5 cases occurred within 6 months and was cut in clinic. There was no case of de novo urinary incontinence and de novo dyspareunia. CONCLUSIONS: Pelvic reconstruction surgery with Prosima is safe and efficacy in treatment of POP stage III. It could improve quality of life remarkably without influence on sexual quality of life.

[Prospective multi-center study in "Xiehe" pelvic floor reconstruction surgery for severe pelvic organ prolapse].

OBJECTIVE: To evaluate clinical efficiency and quality-of-life outcomes in treatment of severe pelvic organ prolapse by the "Xiehe" pelvic floor reconstruction surgery. METHODS: From Jun. 2006 to Dec. 2008, 277 severe pelvic organ prolapse patients with stage III to IV from 8 hospitals in China were enrolled in this prospective study. Pelvic organ prolapse quantitative examination (POP-Q) and anatomic improvement in these patients after surgery were analyzed in this interim study. Comparisons of pelvic floor impact questionnaire-short form 7 (PFIQ-7) and pelvic floor distress inventory-short form 20 (PFDI-20) in these patients before and after surgery was used to evaluate quality of life. Comparison of pelvic organ prolapse-urinary incontinence sexual questionnaire (PISQ) in these patients before and after surgery was used to evaluate quality of sexual life. RESULTS: With a median follow-up of 14.0 months (6 - 28 months), twenty-three patients showed recurrent prolapse (8.3%, 23/277), and anatomical success (< stage 2 in the treated compartment) was 91.7% (254/277). In this series, mesh exposure or erosion rate was 6.9% (19/277). The postoperative de novo stress incontinence rate was 6.5% (18/277). The scores for PFIQ-7 and PFDI-20, and its subscales were significantly improved, the scores of before treatment were lower than those after treatment (P < 0.01). And there was no significant difference in the average score of PISQ before and after the surgery (76.6 ± 15.4 versus 75.5 ± 14.5 versus 73.6 ± 12.6, P > 0.05), but the rate of de novo dyspareunia was 11% (9/80). CONCLUSIONS: "Xiehe" pelvic floor reconstruction surgery was safe and efficacy in treatment of pelvic organ prolapse. It could improve quality of life remarkably with less cost when compared with the traditional total pelvic floor reconstruction surgery.

Clinical assessment for three routes of hysterectomy.

BACKGROUND: Hysterectomy is a very common surgery in gynecology. Ideal surgery for hysterectomy is microinvasive with few complications. There are three major routes of hysterectomy that are currently used. The aim of this study was to identify the differences of peri-operative outcome among the patients who underwent the three different approaches. METHODS: One hundred and one women undergoing hysterectomy for myoma had the procedure performed by laparoscopic assisted vaginal hysterectomy (LAVH), total vaginal hysterectomy (TVH) or total abdominal hysterectomy (TAH) in a randomized study. We compared the course of peri-operative and post-operative outcome for the three different approaches. RESULTS: were evaluated by linear regression analysis, Fisher's exact test and Student's t test for independent samples. RESULTS: The operation time among the three procedures was not significantly different (P > 0.05). The amount of blood loss in the TVH group was less than in the LAVH and TAH groups (P < 0.05). The pain score 3 hours after operation in the LAVH group was significantly lower than in the TAH and TVH groups (P < 0.001). The pain scores in the LAVH and TVH groups were lower than in the TAH group at 24 and 48 hours after operation (P < 0.01). The women who underwent LAVH and TVH had a shorter hospitalization stay (P < 0.001). The highest body temperature after operation in the TAH group was higher than that in LAVH and TVH groups (P < 0.001). CONCLUSIONS: LAVH and TVH are better procedures for women requiring hysterectomy. The peri-operative and post-operative courses of TVH are better than LAVH, excluding the pain score 3 hours after operation. Vaginal hysterectomy is the most cost-effective approach but the final choice for the route of hysterectomy can depend on many factors such as gynecological disease, patients' health status and experiences of the gynecologist.

[Clinical study on tension-free vaginal tape and tension-free vaginal tape obturator for surgical treatment of severe stress urinary incontinence].

OBJECTIVE: To investigate the clinical efficacy and improvement of patients' quality of life in tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) for surgical treatment of severe female stress urinary incontinence. METHODS: This study was a randomized, single-blinded, controlled trial. Patients were randomized by a computer-generated randomization schedule with allocation to either TVT or TVT-O procedure. TVT procedure was performed in 35 cases and TVT-O in 34 cases. None had received surgery for urinary incontinence or was in pregnancy. Transvaginal hysterectomy and prolapse reparation were done simultaneously in some of the patients. All patients were requested to complete the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) as part of their pre- and postoperative assessment. RESULTS: All patients were evaluable and the mean follow-up was 14.5 months. The mean operative time was (18 +/- 5) min in the TVT-O group, significantly shorter than in the TVT group (27 +/- 5) min (P < 0.01). The two groups did not differ significantly in perioperative blood loss, postoperative complications (including tape erosion, pain in thigh or behind pubis), postvoid residual volume, hospital stays or expenses (all P > 0.05). Sixty patients were successfully treated for stress urinary incontinence (88.6% and 85.3% for TVT and TVT-O groups, respectively). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P < 0.01), except in subscale measuring symptoms of voiding dysfunction (P > 0.05). CONCLUSIONS: Both techniques appear to be equally effective in the surgical treatment of severe stress urinary incontinence in a short term review. Significant improvements could also be seen in patients' quality of life. However, TVT-O has a shorter operative time. No evidence of increasing risk of urethral obstruction after the operation could be found. Long term follow-ups are necessary to evaluate outcomes of different types of surgery for stress urinary incontinence.

[Etopside, methotrexate, kengshengmycin/etopside, cisplatin chemotherapy for chemorefractory gestational trophoblastic tumour].

OBJECTIVE: To evaluate the results of etopside, methotrexate, kengshengmycin/etopside, cisplatin (EMA/EP) chemotherapy in patients with chemorefractory gestational trophoblastic tumour. METHODS: Fifteen patients with chemorefractory gestational trophoblastic tumour were treated by EMA/EP chemotherapy schedule. RESULTS: Twelve of the fifteen cases were choriocarcinoma, and the other three were metastatic placental site trophoblastic tumour (PSTT). International Federation of Gynecology and Obstetrics (FIGO), 2 cases stage I, 10 cases stage III, 3 cases stage IV. Eight cases had FIGO score of 7 to 12, the score of the other 7 cases was over 12. Fifteen patients received a total of 93 cycles of the study regimen. The median number of courses for each patient was 6.2. Eleven cases (73%) achieved a complete remission while 3 patients (20%) had a partial remission, 1 case (7%) showed nonresponse. The main complications for EMA/EP chemotherapy were myelosuppression and gastrointestinal symptoms. CONCLUSIONS: The EMA/EP regimen is an effective treatment for chemorefractory gestational trophoblastic tumour, and the chemotherapeutic results can be further improved while combined with surgery and arterial infusion chemotherapy in the selected patients. Meanwhile, EMA/EP regimen should be considered in the primary management of patients with metastatic PSTT.