Trocarless system for mesh attachment in pelvic organ prolapse repair��1-year evaluation

Introduction and hypothesis  

EndoFast Reliant™ system is a novel technology for pelvic organ prolapse (POP) repair that attaches mesh directly with metal fasteners.     

Vaginal mesh repair: is it appropriate for pelvic organ prolapse in a nulliparous female following pelvic ring fracture?

Pelvic organ prolapse (POP) in a nulliparous woman is a rare sequela of high-energy pelvic trauma. We report a case of a 26-year-old nulliparous woman who developed stage III pelvic organ prolapse two decades after pelvic ring disruption. Abdominal wall cervicopexy was performed as a primary procedure by her attending local gynecologist. Recurrence occurred in early postoperative period following which she was referred to our institute. Examination revealed 5-cm pubic symphysis widening and stage III pelvic organ prolapse with deficient perineal body. Widened levator hiatus with atrophic pelvic floor muscles were confirmed on MRI. The patient was successfully managed by sacrospinous hysteropexy using predesigned vaginal mesh kit along with anterior colporrhaphy and colpoperineorrhaphy. Mesh exposure detected at the 6th year of follow-up required partial excision of the exposed mesh.     

Vaginal repair of supratrigonal vesicovaginal fistulae—a 10-year review

Introduction and hypothesis

A 10-year retrospective study was done to determine the outcome of vaginal repair for supratrigonal vesicovaginal fistulae (VVF).

Methods

One hundred thirty-two urinary fistulae were managed from 2001 to 2011 which include 34 ureterovaginal and 98 lower urinary tract fistulae. Fifty-three out of 98 were supratrigonal VVF, 49 were of benign etiology and 4 were malignancy induced. Further analysis of 49 supratrigonal VVF of benign etiology revealed that 38 (77.5%) were of gynecological origin and 11 (22.5%) obstetric. Forty-three were primary and six were recurrent VVF. Thirty (61.2%) supratrigonal VVF were repaired vaginally and 19 (38.8 %) abdominally. Mean follow-up period was 51.7?months.

Results

The successful outcome for vaginal and abdominal repair was 86.7% and 100%, respectively (p value?=?0.26). Overall, 91.8% supratrigonal VVF were cured at our first attempt.

Conclusions

Majority of supratrigonal VVF can be approached vaginally with success rate comparable to abdominal approach.     

Use of the Gynecare Prolift? system in surgery for pelvic organ prolapse: 1-year outcome

Introduction and hypothesis  

This retrospective study reports the 1-year outcome in women who underwent mesh-augmented Prolift? surgery performed from 2006 to 2008. There were a total of 254 patients, with 128, 106 and 20 patients receiving total, anterior and posterior Prolift?, respectively.     

Laparoscopic ventral hernia repair using a novel intraperitoneal lightweight mesh coated with hyaluronic acid: 1-year follow-up from a case–control study using the Hernia-Club registry

Purpose

A case–control study was performed to compare laparoscopic ventral hernia repair (LVHR) using the Ventralight ST? lightweight surgical mesh with LVHR using other types of mesh.

Methods

Adult patients undergoing intraperitoneal implantation of Ventralight ST? during LVHR (Ventralight ST? group; VG) over a 2-year period (2011–2013) were identified from the prospective French Hernia-Club registry. Patients undergoing elective LVHR using other types of intraperitoneal mesh in the first semester of 2013 formed the control group (CG). Patient, hernia and surgical characteristics, and postoperative outcomes after 8 days, 1 month, and 1 year were compared between the two groups.

Results

The VG comprised 90 LVHRs in 85 patients, and the CG 86 LVHRs in 81 patients. Patient, hernia and surgical characteristics were similar between the two groups, apart from the method of mesh fixation and the number of procedures involving fascial closure. A low rate of minor complications was observed in both groups at 1 month [4.4 % (VG) and 2.3 % (CG)], and the level of postoperative pain was similar in the two groups at Day 8 and 1 month. After 1 year, no complications, recurrences or cases of chronic pain had occurred in either group, and Quality-of-Life outcomes were similar. Patients rated their procedure as excellent or good in 96 % (VG) and 92 % (CG) of cases.

Conclusions

Ventralight ST? mesh is effective and well tolerated in LVHR, producing very low complication and recurrence rates in the short and medium term. The results are comparable to those achieved with other types of mesh.

     

Anterior sacrospinous ligament fixation associated with paravaginal repair using the Pinnacle™ device: an anatomical study

Introduction and hypothesis  

The objective of this paper is to study the reproducibility and anatomical risks of anterior sacrospinous ligament (SSL) fixation associated with paravaginal repair using the Pinnacle™ device (Boston Scientific™).     

The impact of the Harmonic FOCUS™ on complications in thyroid surgery: a prospective multicenter study

In recent years, newer tools have been developed and used in thyroid surgery. This study compared patients with multinodular goiter undergoing thyroidectomy using the Harmonic FOCUS? with patients undergoing the clamp-and-tie technique. Medical records of 268 patients with multinodular goiter undergoing thyroidectomy from December 2006 to July 2011 in two centers in Italy, the Department of Surgery of Pisa and the General Surgery Unit of Grosseto, were prospectively evaluated. Patients were divided into group A (Harmonic FOCUS? Shear), and group B (clamp-and-tie technique). Patient demographics and specific end points analyzed included age, sex, diagnosis, thyroid gland volume, operative time, complications, need for clips and hemostatic agents, need for suction balloon, postoperative blood loss, and postoperative hospital length of stay. 141 patients were included in group A, and 127 patients were included in group B. The two groups were similar in age, sex ratio, indication for surgery, and thyroid volume. Mean operative time was significantly shorter with the Harmonic FOCUS? Shear (51.8 min) than with the clamp-and-tie technique (70.9 min). The mean postoperative amount obtained from the suction balloon was similar. Vascular clips were needed significantly more frequently in group A (26.2 %) than in group B (12.5 %), whereas the need for hemostatic agents was significantly reduced in group A (4.2 %) compared with group B (14.9 %). The decision to leave a suction drain at the end of the operation occurred significantly more frequently in group B (96 %) than in group A (78 %). Mean postoperative hospital length of stay was 2.02 days in group A compared with 3.1 days in group B, which was significant. No definitive postoperative complications were documented in either group, except a higher rate, but not statistically significant, of permanent hypoparathyroidism in group B versus Group A. Transient laryngeal nerve injury was similar in both groups, whereas transient hypoparathyroidism occurred more frequently in Group B (4.7 %) than in Group A (2.4 %). Harmonic FOCUS device was significantly associated with lower rate of postoperative transient hypocalcemia, decreased operative time, shorter hospitalization, and lesser need for hemostatic agents and postoperative drain balloon. These results might be considered “indirect” money-saving factors, despite the cost of the device, especially in countries where the cost of thyroidectomy is influenced also by the hospital length of stay.     

Evaluating the porcine dermis graft InteXen® in three-compartment transvaginal pelvic organ prolapse repair

Introduction and hypothesis

The aim was to assess the efficacy of three-compartment pelvic organ prolapse (POP) vaginal repair using the InteXen® biocompatible porcine dermal graft as compared to traditional colporrhaphy with sacrospinous ligament suspension.

Methods

Preoperative, operative, postoperative and follow-up data were collected retrospectively. Objective recurrence was defined as POP quantification ≥ stage II and subjective recurrence as a symptomatic bulge.

Results

Each group consisted of 63 patients. Surgery time was longer using InteXen® (72?±?24.5 vs 55?±?23.5 min, p?=?0.0002). Length of hospital stay (4.6?±?1.6 vs 4.9?±?2.1 days, p?=?0.34) as well as duration of follow-up (37.1 vs 35.7 months, p?=?0.45) were equivalent between the two groups. No case of mesh erosion or infection was noted. The objective (17% vs 8%, p?=?0.12) and subjective recurrence rates (13% vs 5%, p?=?0.12) between the two groups were not statistically different.

Conclusions

InteXen® was well tolerated but had similar efficacy to traditional colporrhaphy and sacrospinous ligament suspension.     

The cube pessary: an underestimated treatment option for pelvic organ prolapse? Subjective 1-year outcomes

Introduction and hypothesis

Pelvic organ prolapse (POP) is a common condition. The use of pessaries for conservative management of POP is widespread. However, there are little data on the use of cube pessaries. The aim of our study was to evaluate whether self-therapy with the use of vaginal cube pessaries in women with POP can be a well-tolerated, first-line treatment.

Methods

In a prospective case series, 87 women who suffered from symptomatic POP, stages II–IV, were instructed in self-treatment with a vaginal cube pessary. Differences were analyzed using Wilcoxon’s rank sum test or Fisher’s exact test.

Results

A pessary could be fitted in 84/87 patients (96.6 %); 6 women were lost to follow-up. The remaining 78 patients (92.9 %, median age 60 years) completed the study. Sixteen women (20.5 %) chose not to continue with the pessary treatment. For these patients, general well-being decreased from a median numeric rating score (NRS) of 4.5 (3–6) to 2.0 (1–3, p?<?0.001). In those who continued treatment, general well-being increased from a median NRS of 3.0 (2–5) to 8.0 (7–10, p?<?0.001) after 1 year of use. The majority of patients (53) in the present study rated pessary self-care use as “very easy” or “easy” (85.5 %). The Patient Global Impression of Improvement (PGI-I) was 2.0 (1–3) at follow-up examination. There were no complications or adverse effects of pessary use.

Conclusions

Conservative self-treatment with vaginal cube pessaries might be a feasible treatment option for women who suffer from POP.     

Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse—2-year follow-up

Introduction and hypothesis

The search for an improved vaginal mesh prompted the development of a new anchorless implant. The objective was to report on outcome after 2 years of a technique using a self-retaining support (SRS) implant.

Methods

Patients with anterior vaginal wall prolapse, with/without apical prolapse, were recruited. Participants underwent surgical repair using the SRS device. Demographic data, pre-surgical Pelvic Organ Prolapse Quantification (POP-Q) scoring, quality of life (QoL) questionnaires (Pelvic Floor Distress Inventory Short Form 20 [PFDI-20], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 [PISQ-12]), and surgical data were collected. Patients were followed at 2 weeks, 2, 6, 12, and 24 months after surgery. Objective anatomical success was defined using the NIH criteria.

Results

Twenty women were recruited for the study with an average age of 62.1 years and an average parity of 4.0 deliveries. Average BMI was 28. Pre-operative mean POP-Q measurements were Aa =1.40 (?1 to 3) cm, Ba = 2.3 (?1 to 6) cm and C = 0.4 (?7 to 6) cm. Surgical time averaged 31.2 min. Estimated blood loss averaged 165 ml. No intra-operative complications were observed. One case (5%) of frame erosion was documented 8 months after surgery. At 2 years’ follow-up, mean POP-Q measurements were: Aa = ?2.95 (?3 to ?2) cm, Ba = ?2.85 (?3 to ?2) cm, and C point ?6.90 (?10 to ?3) cm. Seventeen (85%) patients had stage 0 and 3 patients (15%) had stage 1. No mesh erosions or chronic pelvic pain were documented at follow-up. The total PFDI score at follow-up was decreased by 92.8 points (p < 0.0001).

Conclusions

At 2 years’ follow-up, the SRS implant was found to be safe, showing no intra-operative or immediate post-operative complications. All women presented with POP-Q measurements of the anterior and apical compartment at normal value (Ba ≤ ?2 cm) and statistically significant subjective improvement.

     

Prolapse repair using the Elevate? kit: prospective study on 70 patients

Introduction and hypothesis

The aim of this study was to examine the anatomical and functional results of prolapse repair by a vaginal approach using the Elevate kit.

Methods

This was a prospective study of 70 patients presenting with symptomatic urogenital prolapse. Twenty Elevate Anterior, 16 Posterior, and 34 Anterior and Posterior repair systems were placed. Perioperative and postoperative complications were assessed. The patients were interviewed at 2?months and 1?year post-surgery.

Results

Recurrences were recorded in 21 patients (31.3%) at the 1-year follow-up. However, at the 1-year follow-up, there were 14 cases (20.9%) of direct recurrence (two anterior, two posterior, and ten combined anterior and posterior) compared with seven cases (10.4%) of indirect recurrence. Of the 21 failures (stage ≥2), 13 were stage 2 with the leading edge above the hymen. None of the patients underwent revision surgery. The exposure rate was 4.5%. The anterior and posterior shrinkage rates were 68.7% and 31.9%, respectively. There were four cases of de novo dyspareunia. Patients reported a significant decrease in the impact of pelvic floor distress on the PFIQ-7 questionnaire, but an improvement on the PFDI-20. There was no improvement in sexual function (PISQ-12).

Conclusions

The Elevate? kit is associated with satisfactory functional results. However, the anatomical results require ongoing evaluation.     

RevoLix™ vaporesection of the prostate: initial results of 54 patients with a 1-year follow-up

Multiple laser systems for the treatment of benign prostatic hyperplasia (BPH) have been introduced. Current laser systems have limitations due to their laser physics. The RevoLix™ laser combines the advantages of the Holmium:YAG laser with the comfort of a continuous wave (cw) laser beam. This study reports the preliminary results of vaporesection (simultaneous vaporization and resection) of the prostate, using the 2 μm cw laser. A total of 54 consecutive patients were treated with the 70 W RevoLix™ laser for BPH. The mean age was 61 years. Mean prostate volume was 30.3 cc. A 550 μm RigiFib™ bare-ended fiber was used in combination with a 26 French laser resectoscope. Measured outcomes were resection time, decrease in hemoglobin and transfusion rate. Furthermore, the catheter time, improvement in the urinary flow rate (Q _max), post-voiding residual urine (PVR), International Prostate Symptom Score (IPSS) and Quality of Life Index (QoL) were recorded. Average resection time was 52 min. After crossing the learning curve, a tissue ablation of 1.5 g/min was possible. Transfusions were not necessary in any patient. Catheter time was 1.7 days. Q _max significantly improved from 4.2 to 20.1 ml on average. PVR decreased from 86 to 12 ml. IPSS and QoL-Score improved from 19.8 to 6.9 and 4 to 1, respectively. No patient required re-hospitalization. These preliminary results indicate that RevoLix™ vaporesection of the prostate is safe and efficient. One-year follow-up data showed a significant improvement in voiding symptoms and patients’ quality of life. A longer follow-up is needed to prove the durability of these promising results. T. Bach and T.R.W. Herrmann contributed equally to this paper.     

Reoperation for pelvic organ prolapse: a Danish cohort study with 15–20 years’ follow-up

Introduction and hypothesis

The objectives were to determine the reoperation rate of primary pelvic organ prolapse (POP) surgery, to describe the age distribution of the women at primary surgery for those undergoing a reoperation, and to describe the incidence of second and third reoperations.

Methods

We carried out a population-based registry study of Danish women above the age of 18 years when undergoing primary surgery for POP during the period 1996–2000. Data were retrieved from the Danish National Patient Register. All women were followed until one of the following events occurred: reoperation for POP, death, emigration, or end of follow-up period. Reoperation was defined as “repeated surgery in same compartment”. The cumulative incidence rate of reoperation was divided into three compartments (anterior, apical, and posterior) and was calculated using Kaplan–Meier plots.

Results

A total of 18,382 procedures were performed on 11,805 women. After 20 years’ follow-up, the cumulated incidence rate of reoperation for POP in the anterior, apical, and posterior compartments was 12.4%, 7.9%, and 12.1% respectively. The overall rate of reoperation was 11.5%. Of women aged between 18 and 49 years of age at primary surgery, 26.9% had a reoperation, whereas in women between 50 and 90+ years of age at primary surgery, only 10.1% had a reoperation.

Conclusions

This large study with up to 20 years’ follow-up has found that reoperation for POP is modest, that the reoperation rate is lowest for the apical compartment, but highest in all three compartments during the first year after primary surgery. The reoperation rate peaks in the group of women who had their primary surgery before the menopause in all three compartments.

     

Vaginal repair of neobladder–vaginal fistula: a case report and review of the literature

Neobladder substitution after radical cystectomy for invasive cancer has become commonplace as it preserves normal volitional voiding through the native urethra and avoids urinary diversion. Neobladder–vaginal fistula (NVF) is a rare postoperative complication of this procedure that results in decreased quality of life. We describe a case of vaginal repair of a NVF and present a review of the literature.     

Comparing different tissue-engineered repair materials for the treatment of pelvic organ prolapse and urinary incontinence: which material is better?

Introduction and hypothesis

Synthetic non-absorbable meshes are widely used to augment surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but these meshes are associated with serious complications. This study compares the attachment and extracellular matrix (ECM) production of adipose-derived stem cells (ADSCs) on different biodegradable nanomaterials to develop tissue engineered repair materials.

Methods

Rat ADSCs were isolated and cultured on electrospun poly-L-lactic acid (PLA) and electrospun poly(L-lactide)-trimethylene carbonate-gycolide (PLTG) terpolymers for 1 and 2 weeks. Samples were tested for cell proliferation (cell counting kit-8), microstructure, and morphology (scanning electron microscopy), production of ECM components (immunostaining for collagen I, collagen III, and elastin) and biomechanical properties (uniaxial tensile methods).

Results

The ADSCs showed good attachment and proliferation on both PLA and PLTG scaffolds. The production of collagen I and collagen III on both scaffolds was greater at 14 days than at 7 days and was greater on PLTG scaffolds than on PLA scaffolds, but these differences were not significant. The addition of ADSCs onto scaffolds led to a significant increase in the biomechanical properties of both PLA and PLTG scaffolds compared with unseeded scaffolds.

Conclusion

These data support the use of both PLA and PLTG as tissue-engineered repair materials for POP or SUI.

     

Lightwand intubation using the Trachlight™: a brief review of current knowledge

PURPOSE: About 1% to 3% of laryngoscopic intubations can be difficult or impossible. Light-guided intubation has been proven to be an effective, safe, and simple technique. This article reviews current knowledge about the newer version lightwand: the Trachlight (TL). SOURCE: To determine its clinical utility and limitations, we reviewed the current literature (book and journal articles) on the TL since its introduction in 1995. PRINCIPAL FINDINGS: TL has been shown to be useful both in oral and nasal intubation for patients with difficult airways. It may also be useful in "emergency" situations or when direct laryngoscopy or fiberoptic endoscopy is not effective, such as with patients who have copious secretions or blood in the oropharynx. TL can also be used for tracheal intubation in conjunction with other devices (laryngeal mask airway -LMA-, intubating LMA, direct laryngoscopy). However, TL should be avoided in patients with tumours, infections, trauma or foreign bodies in the upper airway. CONCLUSIONS: Based on the clinical reports available, the TL has proven to be a useful option for tracheal intubation. In addition, the device can also be used together with other intubating devices, such as the intubating LMA and the laryngoscope, to improve intubating success rates. A clear understanding of the principle of transillumination of the TL, and an appreciation of its indications, contraindications, and limitations, will improve the effectiveness of the device as well as reducing the likelihood of complications. Finally, regular practice with the TL with routine surgical patients requiring tracheal intubation will further improve intubation success rates.     

Natural history of pessary use in women aged 65 – 74 versus 75 years and older with pelvic organ prolapse: a 12-year study

Introduction and hypothesis

The feasibility of use and long-term outcomes of vaginal pessaries for the management of pelvic organ prolapse (POP) in older women remains unknown. Our aim was to determine successful fit rates and outcomes among older women seeking care for POP.

Methods

This was a retrospective cohort study of 304 consecutive women aged 65 years and older with symptomatic POP undergoing a pessary trial at the outpatient urogynecology clinic in Québec, Canada. Women successfully fitted with a pessary were followed, and survival curves were used to ascertain the median time to pessary discontinuation for women aged 65 to 74 years in comparison with women aged 75 years and older. Long-term use was defined as longer than 1 year. Predictors of a successful fitting and long-term discontinuation were ascertained using logistic and Cox regression analyses.

Results

Half of the women attempting a pessary trial were aged 75 years and older, and 63 % were fitted successfully regardless of age. Women with a history of hysterectomy or reconstructive pelvic surgery, or those with posterior vaginal wall prolapse were more likely to fail initial insertion. For women aged 65 to 74 years and women aged 75 years and older, the cumulative probabilities of continued pessary use were 87.5 % and 80.8 % at 1 year, 80.6 % and 70.9 % at 2 years, and 62.1 % versus 37.8 % at 5 years. Erosions occurred in 19.3 % of long-term users, with women aged 75 years and older more likely to experience vaginal erosions (HR 3.2, 95 % CI 1.6 – 6.3) and discontinue pessary use.

Conclusion

Pessary use is a feasible and acceptable treatment option for the long-term management of symptomatic prolapse in over 60 % of all women aged 65 years and older.

     

Pelvic floor ultrasound in prolapse: what��s in it for the surgeon?

Pelvic reconstructive surgeons have suspected for over a century that childbirth-related trauma plays a major role in the aetiology of female pelvic organ prolapse. Modern imaging has recently allowed us to define and reliably diagnose some of this trauma. As a result, imaging is becoming increasingly important, since it allows us to identify patients at high risk of recurrence, and to define underlying problems rather than just surface anatomy. Ultrasound is the most appropriate form of imaging in urogynecology for reasons of cost, access and performance, and due to the fact that it provides information in real time. I will outline the main uses of this technology in pelvic reconstructive surgery and focus on areas in which the benefit to patients and clinicians is most evident. I will also try and give a perspective for the next 5 years, to consider how imaging may transform the way we deal with pelvic floor disorders.