Adhesion barriers and topical hemostatic agents are risk factors for post-cesarean section infections.

BACKGROUND: Cesarean sections are the most common surgery worldwide, and post-cesarean section infections and hemorrhage are a major cause for morbidity and mortality. In recent years, many surgeons use adhesion barriers as well as hemostatic agents during primary and repeated cesarean section. The data regarding the safety of these agents is relatively limited. The objective of this study was to investigate whether the use of adhesion barriers and topical hemostatic agents pose a risk for post-cesarean section infections. METHOD: A case-control study composed of women who were admitted to the Soroka University Medical Center between the years 2012 and 2016 was conducted. The study group was composed of women admitted owing to post-cesarean section infections (cases) and those who underwent cesarean sections without post-cesarean section infection (control subjects). Matching was done according to date and surgery setting (elective versus emergency). A univariate analysis was followed by a multiple regression model in order to examine the association between adhesion barriers/hemostatic agents and post-cesarean section infections. RESULTS: During the study period, 113 patients developed postoperative infection (cases); 71.7% were diagnosed with surgical site infection, 7.1% with endometritis, and 21.2% with other infections. These were compared with 226 control subjects. In the univariate analysis, the use of adhesion barriers/hemostatic agents were found to be associated with post-cesarean section infection. Using a multivariable analysis controlling for previous cesarean section, skin closer technique, preterm delivery, and duration of surgery >60 minutes, the use of adhesion barriers as well as hemostatic agents was found to be independently associated with post-cesarean section infection (adjusted odds ratio = 2.11, 95% confidence interval = 1.17-3.84; adjusted odds ratio = 2.29, 95% confidence interval = 1.37-3.8, respectively) CONCLUSION: Adhesion barriers and hemostatic agents were found to be independently associated with post-cesarean section infections. Further larger studies are needed to reinforce our findings. The use of these materials should be carefully considered, and their cost-effectiveness re-examined.

Peritoneal adhesions do not increase intra-operative organ injury or adverse neonatal outcomes during a repeated cesarean delivery.

PURPOSE: To examine whether the presence of peritoneal adhesions at the second cesarean delivery (CD), attributable to the first CD, are associated with maternal intra-operative organ injury and adverse neonatal outcomes. METHODS: A retrospective cohort study was conducted, comparing severe maternal intra-operative organ injury and adverse neonatal outcomes, between women with and without peritoneal adhesions. All women with two CDs during the follow-up period were included. Women with adhesions diagnosed during the first CD, history of other abdominal or pelvic surgery, pelvic infection or pelvic inflammatory disease, endometriosis, uterine Mullerian anomalies and newborns with known chromosomal or structural abnormalities were excluded, resulting in 7925 women. Intra-operative peritoneal organ injury was defined as a composite of bladder injury, ureteral injury, small bowel injury or hysterectomy. The examined adverse neonatal outcomes were low 1 and 5 min Apgar scores, intrapartum death (IPD) and postpartum death (PPD). Multivariate logistic regression was performed. RESULTS: Peritoneal adhesions at the second CD, attributable to the first CD were diagnosed in 32.6% of patients (n = 2581). The presence of peritoneal adhesions was not found to be independently associated with intra-operative organ injury nor with 5 min Apgar scores, IPD and PPD. Second CDs complicated with adhesions were found to be associated with low (< 7) 1 min Apgar scores (adjusted OR 1.38, CI 1.20-1.58, p < 0.001). CONCLUSION: Adhesions attributable to a previous CD do not seem to increase the risk for intra-operative organ injury and adverse neonatal outcomes. These findings may assist in reassuring patients who are facing a second CD.

Peritoneal adhesions during cesarean delivery are an independent risk factor for peri-partum hemorrhagic complications.

OBJECTIVE: To investigate whether the presence of peritoneal adhesions at the second cesarean delivery (CD) are associated with peri-partum hemorrhagic complications. STUDY DESIGN: A retrospective cohort study was undertaken, comparing hemorrhagic complications in the second CD, between women with and without adhesions. All women with two CDs who delivered a singleton in their second CD between the years 1988-2016 at a large regional medical center in Israel were included. Women with adhesions diagnosed at the first CD and women with a history of other abdominal or pelvic surgery, pelvic infection or inflammatory disease, endometriosis, uterine Mullerian anomalies and fetal chromosomal or structural abnormalities were excluded from the analysis, resulting in a sample of 7925 women. Peri-partum hemorrhagic complications were defined as a composite of vessel ligation, B lynch procedure during the CD or uterine rupture, third stage or immediate postpartum hemorrhage, blood component transfusion, hemorrhagic shock and maternal anemia [hemoglobin (Hb) levels prior to maternal discharge below 9.0 g\dl]. In order to identify variables that are independently associated with the composite peri-partum hemorrhagic complications a multivariate logistic regression analysis was performed, to control for potential confounders. In addition, a linear regression model was constructed with Hb levels as the outcome variable. RESULTS: During the study period, 32.6 % of patients (n = 2581) suffered from adhesions during the second CD. After adjusting for potential confounders, peri-partum hemorrhagic complications were found to be significantly associated with the presence of peritoneal adhesions (adjusted OR 1.18, CI 1.04-1.33, P = 0.008). A multivariate linear regression analysis revealed that peritoneal adhesions were independently associated with a decline in post-partum Hb levels (ß=-0.055, P < 0.001). CONCLUSION: Adhesions attributable to a previous CD increase the risk for hemorrhagic complications. Interventions aimed at preventing adhesions formation during the primary CD may have a role in reducing hemorrhagic complications in subsequent CDs.

Early prediction of post cesarean section infection using simple hematological biomarkers: A case control study.

OBJECTIVE: We aimed to investigate whether the neutrophil to lymphocyte ratio (NLR) may assist in the prediction of post CS infections. STUDY DESIGN: This was a case control study performed at the Soroka University Medical Center, a large tertiary teaching medical center, between the years 2012-2016. Cases (post CS infection) were matched to controls (without post CS infection) in a proportion of 2:1. Matching was done according to surgery setting (elective vs. urgent) and date of surgery. Various demographic, clinical and obstetrical characteristics were collected. Laboratory tests that were taken 6-24 h postoperatively were compared between the study groups. Univariate analysis was followed by a multivariate one. Area under the curve was calculated for selected indices. RESULTS: During the study period 113 patients who developed postoperative infection were compared with 224 healthy controls. Among patients in the study group, 71.7 % were diagnosed with surgical site infection, 7.1 % with endometritis and 21.2 % with other infections. Total neutrophil and lymphocyte counts were significantly higher among patient in the study group. NLR as well as platelet to lymphocyte (PLR) ratio were significantly higher among patients during the first 24 postoperative hours. NLR and PLR were found to be independently associated with post CS infection controlling for surgery length, use of hemostatic agents/adhesion barrier and skin closure technique (aOR 1.11 95 % CI 1.06-1.17, aOR 1.004 95 % CI 1.001-1.006, respectively). A performance analysis for NLR showed an area-under-the receiver operating curve (AUC) of 67 % (P = 0.006). CONCLUSION: NLR is an easy readily available tool that may have a predictive value in early detection of post CS infection. Further studies are needed in order to support our findings before clinical implications of these findings can be recommended.

Adherence to postpartum diabetes mellitus screening, do associated pregnancy complications make a difference?

AIMS: We aimed to investigate the impact of Gestational Diabetes Mellitus (GDM) complications on compliance with postpartum Diabetes screening. METHODS: A retrospective cohort study was conducted comparing screening rates of women with and without GDM associated complications who delivered at the Soroka University Medical Center, between 2016 and 2017. The screening test of choice was a 2-hour 75 g oral glucose tolerance test, taken 6-12 weeks after delivery. GDM associated complications included one or more of the following: polyhydramnios, macrosomia, shoulder dystocia or cesarean section. Univariate analysis was used in order to examine if GDM associated complications were associated with postpartum diabetes screening. RESULTS: During the study period a 164 women were included, of which, 82 women had suffered from GDM associated complications and comprised the study group and 82 women with GDM but without complications comprised the comparison group. Women in the study group were significantly older with a higher parity order. Induction rates were significantly higher among the comparison group, whereas, cesarean section rates were higher among the study group. No difference was noted with regard to neonatal outcomes. Women in the study group were not found to be more likely to be given screening recommendations at discharge (P = 0.50), at their postpartum visit (P = 0.36) or to perform DM screening postpartum (P = 0.17). CONCLUSION: Women with GDM associated complications had a higher rate of compliance to postpartum DM screening recommendations. However, in the current study this difference did not reach statistical significance.

Peritoneal adhesions are an independent risk factor for peri- and post-partum infectious morbidity.

OBJECTIVE: To investigate whether the presence of peritoneal adhesions during a second cesarean delivery resulting from the first cesarean delivery, are associated with peri- and post-partum infectious morbidity. STUDY DESIGN: A retrospective cohort study was undertaken, comparing maternal peri- and immediate post-partum infectious morbidity during the second cesarean delivery, between women with and without adhesions resulting from the first cesarean delivery. All women over 18 years old at their second cesarean delivery, with a singleton pregnancy between the years 1988-2016 were included in the analysis. Patients with previously diagnosed adhesions during the first cesarean delivery, a history of other abdominal or pelvic surgery, pelvic infection or pelvic inflammatory disease, endometriosis, uterine Mullerian anomalies, and births of newborns with known chromosomal or structural abnormalities were excluded from the analysis, resulting in a study population of 7925 women. Infectious morbidity was defined as a composite of chorioamnionitis, post-partum fever, urinary tract infection and surgical wound infection or disruption. In order to identify factors that are independently associated with infectious morbidity, multivariate logistic regression analyses were constructed to control for potential confounders. RESULTS: During the study period, 32.6% (n = 2581) women were diagnosed with adhesions at the second cesarean delivery. Second cesarean deliveries complicated with adhesions were characterized by higher rates of peri- and post-partum maternal infectious morbidity (6.5% vs. 9%, p < 0.001). Our study population comprises two ethnic groups- Jewish (54.3%) and Bedouin Arabs (45.7%). We have tested interactions with adhesions of all predictor variables in the model. Since we found a strong interaction between adhesions and ethnicity, stratified data are presented. Infectious morbidity was significantly associated with the presence of peritoneal adhesions only among Jewish women (adjusted OR 2.09, PV < 0.001, 95% CI 1.56-2.80), adjusting for potential confounding variables and significant interactions. CONCLUSION: Cesarean delivery complicated with adhesions attributable to a previous cesarean delivery, increase the risk for peri- and immediate post-partum infectious morbidity among Jewish women.

Long-term effects of episiotomy on urinary incontinence and pelvic organ prolapse: a systematic review.

PURPOSE: To focus attention on the long-term effects of episiotomy on urinary incontinence and pelvic organ prolapse. METHODS: A systematic review was conducted including only studies with mean follow-up ≥ 5 years. We searched using combinations of the following keywords and text words: "episiotomy", "perineal laceration", "perineal tear", "perineal damage" and "long term", "long term outcomes", "prolapse", "pelvic organ prolapse", "pelvic floor", "pelvic floor dysfunction", "urinary incontinence", "hysterocele", "cystocele" and "rectocele". RESULTS: The electronic database search provided a total of 6154 results. After exclusions, 24 studies were included yielding the following results: (1) episiotomy might be detrimental with respect to urinary incontinence symptoms; (2) the relationship between episiotomy and anti-incontinence surgery is not clear; (3) episiotomy does not seem to negatively influence genital prolapse development and might even be protective with respect to prolapse severity and prevalence; (4) episiotomy does not seem to affect genital prolapse surgery rate. CONCLUSIONS: We did not find evidence for a long-term beneficial effect of episiotomy in the prevention of urinary incontinence symptoms and anti-incontinence surgery. Episiotomy does not seem to negatively influence genital prolapse development and might even be protective with respect to prolapse severity and prevalence without affecting surgery rates.

Prevalence and risk factors for urinary tract infection following stress urinary incontinence surgery with two midurethral sling procedures.

OBJECTIVE: To compare prevalence and risk factors for urinary tract infection (UTI) following midurethral sling surgery with either the GYNECARE ABBREVO Continence System (Ethicon, Somerville, NJ, USA) or a standard transobturator. METHODS: A retrospective cohort study was conducted among women who underwent midurethral sling surgery to treat stress urinary incontinence at a single tertiary hospital in Israel between January 1, 2014, and August 11, 2015. Data were retrieved from medical records. The diagnosis of UTI was based on a positive urine culture result. RESULTS: Of 178 patients included, 30 (16.9%) underwent the ABBREVO procedure and 148 (83.1%) underwent the standard transobturator procedure. The mean ± SD BMI at the time of surgery was 28.1 ± 4.5 for the standard transobturator procedures and 30.7 ± 15.2 for the ABBREVO procedures. Women who underwent the ABBREVO procedure had an increased duration of hospitalization (P=0.004), and higher rates of concomitant anterior colporrhaphy procedures (P=0.009) and concomitant hysterectomy (P=0.009). Only 38 (21.3%) women developed UTIs within 12 months of surgery (seven in the ABBREVO procedure group and 31 in the standard transobturator procedure group). No statistically significant between-group differences were found for the risk of UTI or for urinary tract adverse events, such as recurrent UTI and the need for rehospitalization. CONCLUSIONS: The two procedures were comparable in terms of prevalence and risk factors for UTI during the postoperative period.

Comparative analysis of early adverse events of pelvic organ prolapse repair with or without transvaginal mesh using Clavien-Dindo classification.

OBJECTIVE: To assess adverse events following surgical repair of pelvic organ prolapse (POP) with or without the use of transvaginal mesh. METHODS: The present retrospective study was conducted among women who underwent surgical POP repair at Soroka University Medical Center, Beer Sheva, Israel, between January 1, 2013, and December 31, 2015. Patients underwent anterior and posterior colporrhaphy either with transvaginal mesh (Elevate Prolapse Repair System; American Medical Systems, Minnetonka, MN, USA) or without transvaginal mesh (native tissue repair). Perioperative adverse events were assessed using the Clavien-Dindo classification; multivariate regression models were constructed to predict minor and major adverse events. RESULTS: There were 111 women included; 35 were treated with transvaginal mesh, and 76 underwent native tissue repair. Women undergoing native tissue repair had a lower mean grade of cystocele (P=0.023) and a higher rate of urinary stress incontinence (P=0.017) than patients treated with transvaginal mesh. The duration of surgery (P=0.002), duration of hospitalization (P<0.001), and the amount of blood loss (P=0.021) were lower in the native tissue repair group. Repair with transvaginal mesh was not associated with increased odds of major or minor adverse events (P>0.05 for all models examined). CONCLUSION: Perioperative and postoperative adverse events were comparable regardless of the operative approach.

Prevalence and risk factors for urinary tract infection up to one year following midurethral sling incontinence surgery.

OBJECTIVE: To investigate the prevalence and risk factors of urinary tract infection (UTI) one year following sub-midurethral sling (SMUS) incontinence surgery in a university affiliated medical center in southern Israel. METHODS: A retrospective cohort study was conducted to identify and characterize patients who suffered UTI within a year following SMUS surgery. The study population comprised of all patients who underwent a SMUS surgery between the years 2014 and 2015. Demographic and clinical data were retrieved from the patients' medical records, and a comparison between patients with and without a positive urine culture was performed. RESULTS: During the study period, there were 178 SMUS surgeries. Urine culture positive UTI was noted in 21% (38 patients) within the first year following surgery. The mean age and BMI of patients complicated with UTI was 64.8 and 29.1, respectively. The most common pathogen found in urine culture was E. coli that accounted for 55% of all UTIs. When comparing patients with and without UTI, no significant difference was noted in the pre- and intra-operative characteristics. However, duration of hospitalization and readmissions in the first year following surgery, were significantly associated with the risk of UTI (p < 0.026 and p < 0.003, respectively). CONCLUSIONS: Approximately one in every five women undergoing a SMUS operation in our population will suffer from UTI within a year from surgery. A significant association was found between the duration of hospitalization and readmissions in the first postoperative year and suffering from UTI.

Independent association between uterine malformations and cervical insufficiency: a retrospective population-based cohort study.

OBJECTIVE: The purpose of our study was to explore maternal and fetal outcomes in the second and third trimester in women with uterine malformations. STUDY DESIGN: This was a retrospective population-based cohort study including women with a diagnosis of uterine malformation arised from workup for infertility or recurrent pregnancy loss, was accidental during pregnancy, or was noticed at the time of cesarean delivery. RESULTS: A total of 280,721 pregnancies met the inclusion criteria and were divided into two study groups: (1) pregnancies in women with uterine malformations (n = 1099); and (2) controls (n = 279,662). The rate of women presenting uterine malformations was 0.39%. The prevalence of cervical os insufficiency was significantly higher in women with a uterine malformation than in the control group (3.6 vs. 0.4%, p < 0.001). A multivariate analysis, performed to evaluate risk factors for cervical insufficiency in women with uterine malformations. Mullerian anomalies (OR 6.19, 95% CI 4.41-8.70, p < 0.001), maternal age (OR 1.05, 95% CI 1.04-1.06, p < 0.001), recurrent abortions (OR 12.93, 95% CI 11.43-14.62, p < 0.001), and ethnicity (OR 2.86, 95% CI 2.454-3.34, p < 0.001) were found to be independently associated with the development of cervical insufficiency. CONCLUSION: Uterine anomalies have a strong association with cervical insufficiency. Women with uterine anomalies have an increased risk to develop pregnancy complications that arise from a loss in cervical function during the midtrimester or early third trimester.

Safety and short term outcomes of a new truly minimally-invasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair

ABSTRACT Objective To evaluate the safety and short term outcomes of a new, truly minimally-invasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. Methods A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients’ six months-follow-up and evaluation are reported. Results The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant. Conclusions This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.

Safety and short term outcomes of a new truly minimallyinvasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair.

OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimallyinvasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. METHODS: A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients' six months-follow-up and evaluation are reported. RESULTS: The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant. CONCLUSIONS: This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.

Native tissue repair for central compartment prolapse: a narrative review.

Central descent due to a level 1 defect is a main component in pelvic organ prolapse (POP) reconstructive surgery, whether for symptomatic apical prolapse or for the prolapse repair of other compartments. A recent growth in the rate of native tissue repair procedures for POP, following the US Food and Drug Administration (FDA) warnings regarding the safety and efficacy of synthetic meshes, requires a re-evaluation of these procedures. The safety, efficacy, and determination of the optimal surgical approach should be the center of attention. Functional outcome measures and patient-centered results have lately gained importance and received focus. A comprehensive literature review was performed to evaluate objective and subjective outcomes of apical prolapse native tissue repair, with a special focus on studies reporting impact on patients' functional outcomes, quality of life, and satisfaction. We performed a MEDLINE search for articles in the English language by using the following key words: apical prolapse, sacrospinous ligament fixation, uterosacral ligament suspension, sacral colpopexy, McCall culdoplasty, iliococcygeus vaginal fixation, and functional outcomes. We reviewed references as well. Despite a prominent shortage of studies reporting standardized prospective outcomes for native tissue repair interventions, we noted a high rate of safety and efficacy, with a low complication rate for most procedures and low recurrence or re-treatment rates. The objective and subjective results of different procedures are reviewed. Functional outcomes of native tissue repair procedures have not been studied sufficiently, though existing data present those procedures as favorable and not categorically inferior to sacrocolpopexy. Apical compartment prolapse repair using native tissue is not a compromise. Functional outcomes of native tissue repair procedures are favorable, have a high rate of success, improve women's quality of life (QoL), and result in high rates of patient satisfaction. This subject requires further long-term, standardized prospective studies following the International Continence Society/International Urogynecologists Association guidelines for surgical outcomes report, with the focus on patient-centered functional outcomes.

IL-1 activity is expressed differently during pregnancy in the rat uterine artery than in aortic or uterine tissues.

PROBLEM: Uterine artery was shown to be unique in its capacity to change in size and function during pregnancy. As interleukin-1 (IL-1) was shown to be involved in reproduction processes, the aim of this study was to determine the levels of IL-1 activity of the uterine artery tissue in pregnant rat. METHOD OF STUDY: Nine virgins and nine midpregnant rats were selected. Both uterine arteries were obtained, together with reference tissues from aorta and uterus. The levels of IL-I were examined in the above tissues after culturing with media alone (control; CT), and media that contained stimulants like tumor necrosis factor-alpha (TNF-a) or lipopolysaccharide (LPS). IL-1-like activity was evaluated by its capacity to promote the culture growth of 1A-5 and cytotoxic T lymphocyte derived (CTLD) cell lines. This activity was expressed as optical density (OD)/mg protein of the examined organ. RESULTS: Uterine artery tissue, of pregnant rats, cultured in medium alone produced significantly higher levels of IL-1 than uterine artery of virgin animals under the same conditions (16.2 S.E. 1.3 versus 0.6 S.E. 0.05 OD/mg protein, respectively; P < 0.02). Stimulation of uterine artery in vitro by LPS and TNF increased their capacity to secrete IL-1. In comparison with uterine artery, aorta produced higher levels of IL-1 in virgin rats compared with pregnant rats (13.6 S.E. 1.2 versus 1.6 S.E. 0.1; P < 0.02). Stimulation of aorta tissues (from both virgin and pregnant rats) with LPS, in vitro, significantly decreased their capacity to secrete IL-1 (P < 0.04). Stimulation of aorta tissues from virgin rats with TNF-alpha, in vitro, did not change their capacity to secrete IL-1 activity. However, stimulation of aorta tissues from pregnant rats with TNF-alpha decreased the secretion of bioactive IL-1. The levels of IL-1 produced by uterine tissues from virgin and pregnant rats were similar, and stimulation with either LPS or TNF-alpha significantly decreased their capacity to secrete IL-1 (P < 0.04). CONCLUSIONS: The high level of IL-1 activity detected during pregnancy in the uterine artery may suggest its unique involvement in the changes occurring throughout pregnancy in those blood vessels.