Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial.

Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure. Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent. Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen. Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217). Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications. Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups. Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure. Trial Registration: TrialRegister.nl Identifier: NTR 6978.

Association of levator injury and urogynecological complaints in women after their first vaginal birth with and without mediolateral episiotomy.

BACKGROUND: Pelvic organ prolapse is a common health problem in women and has a negative influence on quality of life. A major cause of pelvic organ prolapse is levator injury. OBJECTIVE: The objective of the study was to evaluate the association of mediolateral episiotomy with levator injury (levator avulsion, ballooning, or combined) and urogynecological complaints. STUDY DESIGN: A prospective observational cohort study was performed in 204 primiparous women with a spontaneous vaginal delivery without anal sphincter tear in a general hospital between 2012 and 2015. One hundred three of these women had had a mediolateral episiotomy. Validated urogynecological questionnaires and transperineal 3-dimensional/4-dimensional ultrasound were completed after delivery. Outcome measures were levator avulsion, ballooning (hiatal area of more than 25 cm2), and urogynecological questionnaire scores. Statistical analysis was performed using univariate and multiple logistic regression analysis. RESULTS: The median time at investigation after vaginal delivery was 13 months (range 6-33). Levator injury (avulsion, ballooning, or combined) was identified in 35 of the 103 women who had undergone mediolateral episiotomy (40.0%) and 33 of the 101 women without episiotomy (32.7%) (P = .69). No differences were found in the incidence of levator avulsion 27 (26.7%) vs 23 (22.8%) (P = .53) or in levator ballooning (20 [19.4%] vs 23 [22.8%] (P = .58) between both groups. There was an association between longer duration of the second stage of labor and the incidence of levator avulsion (odds ratio, 1.24 [95% confidence interval, 1.01-1.52]). Nonocciput anterior fetal position increased the risk of levator ballooning and levator injury (odds ratio, 10.19 [95% confidence interval, 1.89-54.91] and odds ratio, 12.16 [95% confidence interval, 1.41-104.38], respectively). No differences in urogynecological complaints were found. CONCLUSION: Mediolateral episiotomy is not associated with the occurrence of levator injury or urogynecological complaints in women with a spontaneous vaginal delivery who did not obtain an anal sphincter injury. Levator injury was associated with a prolonged second stage of labor and a nonocciput anterior fetal position.

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

BACKGROUND: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. METHODS: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. TRIAL REGISTRATION: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

The effectiveness of mediolateral episiotomy in preventing obstetric anal sphincter injuries during operative vaginal delivery: a ten-year analysis of a national registry.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) are associated with an increased risk of faecal incontinence after vaginal delivery. The aim of this retrospective population-based cohort study was to assess whether mediolateral episiotomy is associated with a reduction in the rate of OASIS during operative vaginal delivery. METHODS: We used data from the Dutch Perinatal Registry (Perined) that includes records of almost all births between 2000 and 2010 in The Netherlands. In a cohort of 170,969 primiparous and multiparous women whose delivery was recorded, we estimated the association between mediolateral episiotomy and OASIS following both vacuum and forceps deliveries using univariate and multivariate logistic regression analysis. RESULTS: The incidences of OASIS following vacuum delivery in 130,157 primiparous women were 2.5% and 14% in those with and without a mediolateral episiotomy, respectively (adjusted OR 0.14, 95% CI 0.13-0.15), and in 29,183 multiparous women were 2.0% and 7.5%, respectively (adjusted OR 0.23, 95% CI 0.21-0.27). The incidences of OASIS following forceps delivery in 9,855 primiparous women were 3.4% and 26.7% in those with and without a mediolateral episiotomy, respectively (adjusted OR 0.09, 95% CI 0.07-0.11), and in 1,774 multiparous women were 2.6% and 14.2%, respectively (adjusted OR 0.13, 95% CI 0.08-0.22). CONCLUSIONS: The use of a mediolateral episiotomy during both vacuum delivery and forceps delivery is associated with a fivefold to tenfold reduction in the rate of OASIS in primiparous and multiparous women.

The effect of a mediolateral episiotomy during operative vaginal delivery on the risk of developing obstetrical anal sphincter injuries.

OBJECTIVE: The objective of the study was to evaluate the frequency of obstetrical anal sphincter injuries (OASIS) in women undergoing operative vaginal deliveries (OVD) and to assess whether a mediolateral episiotomy is protective for developing OASIS in these deliveries. STUDY DESIGN: We performed a retrospective cohort study. Maternal and obstetrical characteristics of the 2861 women who delivered liveborn infants by an OVD at term in the years 2001-2009 were extracted from a clinical obstetrics database and were analyzed in a logistic regression model. RESULTS: The frequency of OASIS was 5.7%. Women with a mediolateral episiotomy were at significantly lower risk for OASIS compared with the women without a mediolateral episiotomy in case of an OVD (adjusted odds ratio, 0.17; 95% confidence interval, 0.12-0.24). CONCLUSION: We found a 6-fold decreased odds for developing OASIS when a mediolateral episiotomy was performed in OVD. Therefore, we advocate the use of a mediolateral episiotomy in all operative vaginal deliveries to reduce the incidence of OASIS.

Overnight removal of urinary indwelling catheter following vaginal prolapse surgery (OVERACT).

OBJECTIVE: Pelvic organ prolapse is a common condition in women. Adequate timing of urinary catheter removal after vaginal prolapse surgery is essential to reduce post-operative morbidity. We compared midnight removal of the indwelling urinary catheter to removal next morning. METHODS: We performed a retrospective cohort study among 266 women undergoing vaginal prolapse surgery, of whom 132 women had urinary catheter removal at midnight and 134 women morning after surgery. We compared the occurrence of urinary retention, time till first micturition, need for clean intermittent catherization and duration of hospital admission. Also, we assessed risk factors for the occurrence of retention. RESULTS: Retention occurred less after midnight removal of the urinary catheter, compared to removal next morning (6.1 % versus 23.9 %, p < 0.001). Furthermore, the time till catheter removal and discharge from hospital were shorter and the need for clean intermittent catheterization during hospital admission was lower after midnight compared to next morning removal of the urinary catheter. We identified anterior colporrhaphy as a risk factor for retention. CONCLUSION: Our results suggest that early removal of the indwelling urinary catheter after vaginal prolapse surgery seems save with respect to urinary retention and leads to earlier mobilization and shorter hospital admission.

Three-dimensional bladder ultrasonography with the BladderScan® overestimates post void residual one week after delivery.

OBJECTIVE: Postpartum urinary retention is a frequent complication after childbirth. It is usually a temporary condition. However, unrecognised urinary retention can lead to considerable morbidity due to bladder over distention, detrusor atony and long term voiding dysfunction. In our clinic we noticed an overestimation of post void residual measured with the BladderScan® in comparison with catheterization in women one week after delivery. STUDY DESIGN: We included 25 women in this prospective pilot study. These women had a urinary retention over 1000 ml within 4-5 h postpartum. Conform our local protocol, an indwelling catheter was inserted for one week. After removal of the indwelling catheter, a micturition trial was conducted. The post void residual was first measured with BladderScan® (BVI 3000), directly followed by clean intermittent catheterization which is the golden standard at this moment. RESULTS: There was a significant mean difference in post void residual measurements with the BladderScan® and catheterization of 312 ml (95% CI 220-404 ml) (p < 0.001). According to our post void residual definition of 200 ml, the sensitivity and specificity of the BladderScan® was respectively 100% and 17.6%. The positive predictive value was 36%. CONCLUSION: The BladderScan® (BVI 3000) is a non-reliable instrument to measure post void residual one week postpartum. For now clean intermittent catherization remains the golden standard.

Rupture of the posterior cul-de-sac during trial of labour after caesarean section.

Rupture of the vaginal wall in unobstructed labour is a rare entity in the developed world. This case report describes rupture of the posterior cul-de-sac in a healthy 34-year-old multiparous woman attempting trial of labour after caesarean section. The woman presented to the labour ward at term with spontaneous onset of contractions. In the second stage of labour, the woman experienced sudden severe abdominal pain, different in character from the contraction pain. Therefore, the baby was delivered by ventouse extraction. As the woman continued to experience severe immobilising abdominal pain during the hospital stay, a CT scan was performed which revealed a haematoma and free fluid at the right side of the uterus. A laparotomy was performed 3 days postdelivery, during which a rupture of the posterior cul-de-sac was found and closed with a continuous suture. The woman was discharged 3 days after laparotomy in good clinical condition.

Biological markers in pT1 and pT2 ovarian cancer with lymph node metastases.

OBJECTIVE: A relatively high incidence of pelvic and paraaortic lymph node metastases is found in patients with pT1 and pT2 ovarian cancer. This paper investigates the clinicomorphological parameters and the expression of various biological markers in these tumors in order to define possible risk factors for lymphatic dissemination. METHODS: In a retrospective study we identified 51 patients with pT1 and pT2 ovarian cancer. All patients underwent total hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and systemic pelvic +/- paraaortal lymphadenectomy. The incidence of lymph node metastases in these patients and the clinicomorphological parameters of their tumors were examined. Immunohistochemistry was used to determine the expression levels of the cell proliferation marker Ki-67, the cell adhesion molecules CD44s and CD44v6, and the oncoprotein HER2/neu of the tumors and their respective lymph node metastases. RESULTS: Lymph node involvement was found in 5 of 26 patients with pT1 ovarian cancer and in 6 of 25 patients with pT2 ovarian cancer. Serous adenocarcinoma was associated with a significantly higher incidence of lymph node metastases than other histological types (chi(2) = 4.7, P = 0.03). No correlation was found between tumor grade and the lymph node status. High Ki-67 expression was significantly correlated with spread to the lymph nodes (chi(2) = 4.2, P = 0.04), whereas expression of CD44s, CD44v6, and HER2/neu was not related to the lymph node status. Survival analyses showed no difference in disease-free and overall survival in patients with lymph node metastases compared to those without lymph node metastases. No association was seen among histological type, tumor grade, and immunohistochemically detected Ki-67, CD44s, CD44v6, and HER2/neu expression on the one hand and disease-free and overall survival on the other hand. CONCLUSIONS: Our data suggest that in early stage ovarian cancer the serous histological type and tumors showing a high Ki-67 expression carry a high risk of lymph node metastases. With respect to prognosis our data showed a minor role for Ki-67, CD44s, CD44v6, and HER2/neu expression and the occurrence of lymph node metastases in pT1 and pT2 ovarian cancer.