Exo-anal imaging of the anal sphincter: a comparison between introital and transperineal image acquisition.

INTRODUCTION AND HYPOTHESIS: Three-dimensional exoanal ultrasound imaging of the anal sphincter may be obtained transperineally with a convex probe, or at the introitus with a transvaginal probe. We hypothesised that introital acquisition would yield better quality and more reproducible evaluation. METHODS: We acquired three 3D volumes of the anal sphincter (one transperineal transverse with a 4- to 8-MHz convex probe and two introital with a 5- to 9-MHz probe in transverse and mid-sagittal view) in 20 representative women attending the gynaecology clinic. Each 3D dataset was anonymised and hence blinded for clinical data and for acquisition method. Images were analysed off-line by two expert specifically trained ultrasonographers in a random order to assess image quality, sphincter integrity and sphincteric measurements. We assessed the intra- and interrater agreement by the Cohen's kappa (κ) and by the intraclass correlation coefficient for categorical and continuous variables respectively. RESULTS: The mid-sagittal introital acquisition had most inconclusive images owing to unsatisfactory quality, on which raters agreed (К = 0.80). Subsequently, agreement in the anal sphincter evaluation between transverse introital and transperineal acquisitions was compared. Agreement on internal anal sphincter gap was excellent for both transverse introital (К = 0.87) and transperineal acquisition (К = 0.93). Agreement on external anal sphincter discontinuity was excellent for the transperineal acquisition (К = 0.87) and good for the transverse introital acquisition (К = 0.73). Intra- and interrater agreement of external and internal anal sphincteric measurements were best for transperineal acquisitions. CONCLUSIONS: In our hands, transperineal acquisition with a 4- to 8-MHz probe performed better than introital acquisition with a 5- to 9-MHz probe in the assessment of the anal sphincter complex.

Long-Term Assessment of a Prospective Cohort of Patients Undergoing Laparoscopic Sacrocolpopexy.

OBJECTIVE: To report long-term outcomes after laparoscopic sacrocolpopexy. METHODS: We conducted a prospective descriptive cohort study on 331 consecutive patients who underwent laparoscopic sacrocolpopexy for symptomatic prolapse (Pelvic Organ Prolapse Quantification [POP-Q] system stage 2 or greater) at one center, with minimum 1.5 years of follow-up by April 30, 2014. Primary outcome measures were Patient Global Impression of Change score and failure at the apex (C≥-1 cm; POP-Q stage 2 or greater). Secondary outcomes were anatomical failure in other compartments, duration of follow-up, occurrence and time point of complications, reinterventions, and functional outcomes by response to a standardized 24-question interview on prolapse and bladder, bowel, and sexual function. Assessment was by an experienced clinician not involved in patient management. RESULTS: The follow-up rate was 84.6% (280/331); 185 of 331 (55.9%) patients were both physically examined and interviewed, and 95 of 331 (25.7%) were interviewed only. The median age at interview was 72 years (interquartile range 13 years), with a follow-up period of 85.5 months (interquartile range 46 months). Approximately 83% (231/280) reported improvement; 5.7% (16/280) were unchanged, 5.7% (16/280) felt slightly worse, and 6.8% (17/280) reported clear deterioration. Anatomical failure at point-C was 8.6% (16/185); anterior (22.2%, 41/185) and posterior (28.6%, 53/185) prolapse were more common than apical prolapse. Of those with level-I anatomical cure, 10.1% (17/185) felt worse; half of them (9/17) because of prolapse in another compartment. The others had urinary problems (41.2%, 7/17), obstructive defecation (11.8%, 2/17), or dyspareunia (11.8%, 2/17). Conversely, the majority of patients with recurrence at the vault (62.5%, 10/16) self-reported to be improved. The reoperation rate was 17.8% (48/270), including 19 (7.0%) for graft-related complications and nine (3.3%) for prolapse. CONCLUSION: More than four out of five patients (82.5%) felt improved 86 months after laparoscopic sacrocolpopexy. Of those not improved, two thirds had recurrent prolapse; however, typically mid-vaginal. The other third reported urinary or bowel problems or dyspareunia. Reintervention for prolapse was 3.3%. The most common reasons for reoperation were graft-related complications (7.0%) and urinary incontinence (6.7%).

Analysis of the learning process for laparoscopic sacrocolpopexy: identification of challenging steps.

INTRODUCTION AND HYPOTHESIS: We earlier demonstrated that the operation time of laparoscopic sacrocolpopexy (LSCP) by an experienced surgeon drops significantly after 30 cases to reach a steady state after 90. We now aimed to define the learning curve and to identify the most challenging steps for a trainee learning LSCP. METHODS: Prospective consecutive series of 60 patients undergoing LSCP performed by a trainee experienced in operative laparoscopy but not LSCP. Prior to the first case, the trainee primed his endoscopic suturing skills on an endotrainer for 15 h. His operation time and performance score were analysed using moving average analysis (MOA). The former and the occurrence of complications or short-term failures were compared with those of a concurrent control group consisting of patients operated on by a surgeon experienced in LSCP (teacher). The procedure was empirically divided into five consecutive steps (dissection of the promontory, the paracolic gutter and vagina, suturing of the mesh to the vault, stapling to the promontory, and peritonealisation). RESULTS: The MOA of the operation time demonstrated a learning curve for all steps, except for the dissection of and fixation to the promontory. The most time-consuming step is the dissection of the vault, for which it took the trainee 31 procedures to achieve an operation time comparable to that of the teacher. Also, the quality of the dissection improved over time. Suturing of the implant to the vault and peritonealisation took only 10 and 6 procedures respectively. There was no difference in the occurrence of major complications and in one case the trainee asked for assistance. CONCLUSION: Quality of LSCP improves with experience. Operation time falls as well, and the most time-consuming step is the dissection of the paracolic and perivaginal spaces. Prior training in laparoscopic suturing coincided with a short learning process for the phases requiring suturing.

Pain and bleeding pattern related to levonorgestrel intrauterine system (LNG-IUS) insertion.

OBJECTIVE: To investigate whether the pattern or pain or bleeding during levonorgestrel intrauterine system (LNG-IUS) insertion and in the first 6 weeks thereafter is altered by LNG-IUS malposition. STUDY DESIGN: Prospective cohort of 413 women undergoing LNG-IUS insertion or replacement. A first questionnaire on pain perception was completed by the women immediately after insertion. In a second questionnaire the women were asked to record pain in the 3 days following insertion and both pain and bleeding from 4 to 6 weeks after insertion. Six weeks after insertion a 2D- and 3D-ultrasound examination was performed to evaluate the position of the LNG-IUS and of the uterus. RESULTS: Parity was inversely related to pain at insertion, in the first 3 days and at 4-6 weeks. LNG-IUS insertion was less painful in the postpartum period. Women who had had a LNG-IUS as prior contraceptive method reported a higher percentage of amenorrhea at 4-6 weeks. The position of the LNG-IUS or of the uterus did not influence the pain scores or the bleeding pattern. The fact that the LNG-IUS arms appeared embedded in the uterine wall on coronal 3D-volume reconstruction did not influence pain or the bleeding pattern. CONCLUSIONS: Because neither pain nor bleeding is a reliable predictor of LNG-IUS position, we suggest an ultrasound examination to confirm correct LNG-IUS placement in all patients at about 6 weeks after insertion.

Shrinkage and biomechanical evaluation of lightweight synthetics in a rabbit model for primary fascial repair.

INTRODUCTION AND HYPOTHESIS: The experiment evaluated different lightweights (<32 g/m(2)) in terms of shrinkage and biomechanics. METHODS: PP-8 (polypropylene of 7.6 g/m(2)), PP-s (PP-8 with absorbable sheets), PP-32 (PP with absorbable fibers; 32.0 g/m(2)) and polyvinylidinefluoride (PVDF; 24.9 g/m(2)) augmented primary sutured repairs of the anterior abdominal wall in a total of 40 rabbits. Rabbits were implanted by only one type of mesh at four abdominal sites. After 7, 14, 30, 60 and 120 days, 2 rabbits were sacrificed per group. Three additional unoperated rabbits were used as controls. Shrinkage and uni-axial tensiometry were evaluated. RESULTS: PP-s implants wrinkled in 70%. PP-32 did not shrink whereas PP-8 and PVDF shrank by 20%. Explants were as strong as the controls; however, they differed in compliance. At lower stress, the tested materials were equally stiff. CONCLUSIONS: The biomechanical behaviour of the tested lightweights does not mimic that of native controls. Weight reduction does not prevent shrinkage.

Detection of endometrial pathology using saline infusion sonography versus gel instillation sonography: a prospective cohort study.

OBJECTIVE: To compare saline infusion sonography (SIS) with gel instillation sonography (GIS) in terms of feasibility and diagnostic accuracy. DESIGN: Prospective cohort study. SETTING: Leuven University bleeding clinic. PATIENT(S): A total of 804 patients: two consecutive cohorts of 402 women undergoing SIS or GIS. INTERVENTION(S): Vaginal ultrasound (n=804) followed by SIS (n=402) or GIS (n=402); office hysteroscopy in 685 patients, and endometrium sampling in 487 patients; surgery in 274 women: operative hysteroscopy (n=230) or hysterectomy (n=44). MAIN OUTCOME MEASURE(S): Patients' characteristics, technical failure rates, and final diagnosis. Pathology was defined as endometrial hyperplasia, polyp, cancer, or intracavitary myomas. RESULT(S): The technical failure rate (difference between proportions and confidence interval) was 5.0% for SIS versus 1.8% for GIS, respectively (3.21; [0.69-5.95]). Failure due to inadequate distension was 1.5% versus 0.3% for SIS and GIS, respectively (1.25; [-0.16-2.99]). Pathology was diagnosed in 180 patients (49%) of the SIS group versus 147 patients of the GIS group (40.2%) (8.88; [1.69-15.95]). The sensitivity was 77.8% and 85.0%, respectively (NS). The negative predictive value was 79.1% for SIS and 88.6% for GIS (9.54; [2.17-16.89]). CONCLUSION(S): Gel instillation sonography is a feasible, accurate alternative for SIS in the evaluation of women with abnormal bleeding, and has fewer technical failures.

Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts.

PURPOSE: We compared the medium term anatomical and subjective outcome, and graft related complications after sacrocolpopexy for apical vaginal prolapse using xenogenic or polypropylene grafts. MATERIALS AND METHODS: We prospectively studied 50 consecutive patients who underwent laparoscopic sacrocolpopexy with porcine grafts of small intestinal submucosa (21) or dermal collagen (29). We compared these patients to 100 consecutive controls in whom polypropylene was used, and underwent surgery before (50) or after (50) the cases. The primary outcome was anatomical cure (stage I or less at any compartment). Secondary outcomes were graft related complications, subjective cure and quality of life evaluated by clinical examination, standardized interview and prolapse specific questionnaire, respectively. RESULTS: At study closure 129 (86%) patients were available for functional evaluation and 104 (67%) were available for anatomical evaluation. Mean postoperative followup (+/-33 months) and baseline characteristics except age were comparable. The overall anatomical failure rate was comparable (49% vs 34%, p = 0.053) but failures at the vault (21% vs 3%, p <0.01) and posterior compartment (36% vs 19%, p <0.05) were more frequent in the xenograft group. There were 6 reoperations including secondary laparoscopic sacrocolpopexy (5) and cystocele repair (1), all confined to the xenograft group (p <0.01). Graft related complications were equally frequent (11%) in the xenograft and polypropylene groups. The reoperation rate for graft related complications was not different (xenograft 3% vs controls 11%, p = 0.20). There were no differences in functional outcome and quality of life between xenografts and controls. CONCLUSIONS: While overall anatomical failure was comparable, sacrocolpopexy using xenograft was associated with more apical failures and reoperations for prolapse than with polypropylene without differences in functional outcome. The use of xenografts did not decrease the number of graft related complications.

No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination.

OBJECTIVE: The association between infertility and minimal to mild endometriosis is controversial and poorly understood. The clinical pregnancy rate (PR) per cycle after controlled ovarian hyperstimulation (COH) with or without intrauterine insemination (IUI) is reportedly lower in women with surgically untreated minimal to mild endometriosis than in women with unexplained infertility. It is possible that prior laparoscopic removal of endometriosis has a positive effect on the clinical PR after COH and IUI. Therefore, we tested the hypothesis that after COH and IUI the PR per cycle and the cumulative live-birth rate (CLBR) are equal or higher in women with recently surgically treated minimal to mild endometriosis when compared with women with unexplained infertility. DESIGN: A retrospective, controlled cohort study. SETTING: Leuven University Fertility Centre, a tertiary academic referral center. PATIENT(S): One hundred seven women treated during 259 cycles with COH and IUI including patients with endometriosis (n = 58, 137 cycles) and unexplained infertility (n = 49, 122 cycles). All patients with endometriosis had minimal (n = 41, 100 cycles) or mild (n = 17, 37 cycles) disease that had been laparoscopically removed within 7 months before the onset of treatment with COH and IUI. INTERVENTION(S): Controlled ovarian hyperstimulation using clomiphene citrate (23 cycles) or gonadotrophins (236 cycles) in combination with IUI. MAIN OUTCOME MEASURE(S): Clinical PR per cycle and CLBR within four cycles of treatment with COH and IUI. RESULT(S): The clinical PR per cycle was comparable in women with minimal or mild endometriosis (21% or 18.9%, respectively) and in women with unexplained infertility (20.5%). The CLBR within four cycles of COH and IUI was also comparable in women with minimal endometriosis, mild endometriosis, and unexplained infertility (70.2%, 68.2 %, 66.5%, respectively). CONCLUSION(S): The data from our study suggest that COH and IUI shortly after laparoscopic excision of endometriosis is as effective as COH and IUI in patients with unexplained subfertility.