子宫内膜取样器与子宫内膜分段诊刮结果的对照研究

目的评估子宫内膜取样器获取子宫内膜活检组织病理诊断的准确性和组织样本的质量。方法收集北京大学第三医院生殖中心和妇科门诊需进行子宫内膜活检的患者157例,在接受常规分段诊刮术（D＆C）前利用子宫内膜取样器先获取子宫内膜组织。由专业的病理医师进行评估。结果子宫内膜取样器的活检与D＆C的病理诊断符合率为89．8％（141／157）,其中不孕症月经期子宫内膜组和无症状绝经后子宫内膜癌筛查组（筛查组）诊断符合率分别是97．9％（95／97）和lOO％（17／17））,差异无统计学意义（P〉O．05）。子宫肌瘤术前诊刮组（68．8％,11／16）和子宫内膜增生组（55％,11／20）的诊断率明显低于D＆C活检,差异有统计学意义（P〈0．05）。6例子宫内膜癌患者子宫内膜取样器的活检诊断,无一例漏诊。D8℃和子宫内膜取样器获取样本、筛查组和不孕症月经期子宫内膜组织学质量比较,差异无统计学意义（P〉O．05）。结论子宫内膜取样器可用于评价不孕症患者月经期子宫内膜和无症状绝经后子宫内膜癌筛查者子宫内膜,但对于高度可疑子宫内膜癌的患者,需慎重对待阴性结果。     

A randomised trial comparing the H Pipelle with the standard Pipelle for endometrial sampling at 'no-touch' (vaginoscopic) hysteroscopy

Objectives  To evaluate the effectiveness and tolerance of H Pipelle compared with the standard Pipelle as an endometrial biopsy device at outpatient 'no-touch' hysteroscopy.
Design  A prospective randomised trial carried out in an outpatient diagnostic hysteroscopy clinic.
Setting  A large undergraduate teaching hospital.
Population  Sixty women investigated for abnormal menstruation in an outpatient diagnostic hysteroscopy clinic.
Methods  Prospective randomised trial comparing the H Pipelle with the standard Pipelle de Cornier.
Main outcome measures  Adequacy of the biopsy specimens and women's experience.
Results  Ninety-three percent (H Pipelle) and 87% (Pipelle) of the biopsy specimens were judged to be adequate for histological diagnosis ( P > 0.05). However, obtaining endometrial sampling with the H Pipelle was significantly quicker (median times: 39 seconds [H Pipelle] and 102 seconds [Pipelle], P < 0.0001) and less painful (median visual analogue scale score: 1 [H Pipelle] and 5 [Pipelle], P = 0.011).
Conclusions  The H Pipelle not only makes it possible to perform hysteroscopy and endometrial biopsy with minimal instrumentation but is also associated with a shorter biopsy time and less discomfort than the standard Pipelle without any loss of biopsy adequacy.     

Evaluation of the Pipelle curette for endometrial biopsy

The Pipelle endometrial suction curette was evaluated, and its application and effectiveness were compared to those of the Novak curette for endometrial sampling during the midluteal phase. Fifty women underwent an endometrial biopsy with the Pipelle and Novak curettes. Ninety percent of the women preferred the biopsy with the Pipelle. Histologically, tissue obtained with the Pipelle was satisfactory and similar to that with the Novak. The Pipelle curette appears to be an excellent device for midluteal endometrial biopsy during an infertility evaluation.     

Comparison of endometrial biopsy with the endometrial Pipelle and Vabra aspirator

Endometrial biopsy can be used to evaluate women at high risk for endometrial cancer and to follow women on hormone replacement therapy. Biopsy methods may produce enough pain, however, to lower patient acceptance. The Endometrial Pipelle is a new plastic endometrial suction curette that provides a histologic biopsy. This study compared the performance of the Pipelle to that of the Vabra aspirator, a widely accepted biopsy device. Endometrial sampling using both techniques was performed on 56 patients. Both instruments provided the correct diagnosis in 50 patients (89%). The Pipelle obtained more tissue than the Vabra in 28 patients (50%) and was noted by the clinician to cause less pain in 50 patients (89%). Forty-seven patients (84%) stated that biopsy with the Pipelle was less painful than with the Vabra. These results suggest that the Pipelle is as efficacious as the Vabra aspirator and has greater patient acceptability.     

Topical analgesia for endometrial biopsy: a randomized controlled trial

OBJECTIVE: To estimate whether benzocaine spray applied to the cervix and the endocervical canal before performing office endometrial biopsy improves patient comfort during the procedure. METHODS: Eighty-eight women were randomly assigned to receive either 20% benzocaine spray or placebo to the outside of the cervix and into the endocervical canal before an endometrial biopsy was performed. The main outcome measure was pain during the endometrial biopsy, assessed by a visual analog scale. Statistical analysis was performed using Wilcoxon rank-sum test and Student t test. RESULTS: There were no statistically significant differences between the study group and the control group in mean age, race, parity, body mass index, menopausal status, tenaculum use, or history of chronic pelvic pain. No statistically significant differences were found in median pain scores between the 2 treatment groups. CONCLUSION: Topical benzocaine spray does not appear to offer effective pain control in patients undergoing an endometrial biopsy. LEVEL OF EVIDENCE: I.     

A randomized clinical trial comparing the Cytobrush and cotton swab for Papanicolaou smears.

OBJECTIVE: We sought to determine whether use of the Cytobrush/spatula or the cotton swab/spatula is better in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. METHODS: This 1-year randomized trial was performed at the Los Angeles County + University of Southern California Women's Hospital colposcopy clinic. Participants were all nonpregnant patients referred to the colposcopy clinic for abnormal Papanicolaou smears. The main outcome measurement was the effectiveness in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. Data were analyzed using the Pearson chi 2 test. RESULTS: The sampling methods had similar abilities to obtain a satisfactory smear (Cytobrush/spatula 63%, cotton swab/spatula 57%; P = .23). Less-than-optimal smears accounted for 28% of the Cytobrush group and 38% of the cotton-swab group. The Cytobrush was superior in its ability to obtain endocervical cells (Cytobrush 80%, cotton swab 60%; P less than .01). Both sampling methods had similar rates of correlation with histologic diagnosis. No complications were associated with either technique. CONCLUSIONS: The Cytobrush/spatula is superior to the cotton swab/spatula in obtaining endocervical cells. There appears to be no difference in each method's ability to obtain satisfactory smears. Application of the Bethesda System results in a significant number of less-than-optimal smears using either technique.     

A prospective randomized clinical trial comparing two oxytocin induction protocols.

OBJECTIVE: Our objective was to compare the safety and efficacy of two accepted oxytocin induction protocols that differ in oxytocin dose increments. STUDY DESIGN: At the Carolinas Medical Center in Charlotte, North Carolina, 151 women with indications for induction of labor were prospectively randomized into one of two oxytocin induction protocols. Safety and efficacy of the two protocols were analyzed with two-tailed t tests and chi 2. RESULTS: Time from induction to establishment of a regular labor pattern was significantly shorter in the experimental group compared with the traditional group (p = 0.03). However, no significant difference was seen from onset of induction to time of delivery. Incidences of hyperstimulation were not significantly different between the two protocols, but there was a trend toward a higher incidence of fetal heart rate changes in the experimental group (p = 0.08). CONCLUSION: These data suggest that induction with larger dose increments will shorten time to adequate labor without an associated increase in uterine hyperstimulation or poor neonatal outcome. The differences in heart rate changes are concerning and merit further investigation. If confirmed by further studies, an increased risk of cord compression could outweigh the benefit of a faster onset of contractions.     

Anesthetic efficacy of intrauterine lidocaine for endometrial biopsy: a randomized double-masked trial

OBJECTIVE: To determine the efficacy of intrauterine lidocaine for decreasing pain associated with endometrial biopsy using the Pipelle instrument (Unimar; Wilton, CT). METHODS: Forty-one premenopausal and postmenopausal women had 5 mL of either 2% lidocaine or saline instilled in their uteri before endometrial biopsies. Subsequently, each woman completed a 20-cm visual analogue scale for subjective pain experience. We compared histologic findings in endometrial specimens. RESULTS: Before the study, analysis of specimens (n = 6) found no histologic effect on ability to interpret endometrial biopsies by pathologists who were masked to lidocaine or saline. There was no statistically significant difference in age, parity, race, history of chronic pelvic pain, menopausal status, use of tenaculum, or prior endometrial biopsy. The procedure was easy, with no clinically significant side effects. On the visual pain scale, the median (range) score for the lidocaine group (4.7, 0-19.7) compared with the placebo group (9.9, 1.6-20) showed significant reduction in pain corresponding with a decrease from moderate to mild (P < .01). CONCLUSION: Intrauterine lidocaine is simple and effective for decreasing pain associated with the Pipelle endometrial biopsy.     

A randomised controlled trial comparing transvaginal ultrasound, outpatient hysteroscopy and endometrial biopsy with inpatient hysteroscopy and curettage

Objective To compare the use of outpatient and inpatient procedures in the investigation of abnormal uterine bleeding.
Design A randomised controlled trial.
Setting Two university teaching hospitals.
Participants Four hundred women with abnormal uterine bleeding (postmenopausal bleeding, menorrhagia, intermenstrual bleeding, postcoital bleeding, or irregular periods) above the age of 35 years, between June 1993 and January 1995.
Main outcome measures 1. Incidence of detection of abnormal pathology by vaginal ultrasound, outpatient hysteroscopy and endometrial biopsy compared with inpatient hysteroscopy and curettage; 2. Number of 'lesions' (e.g. fibroids, polyps, endometrial hyperplasia or malignancy) found by hysteroscopy that would have been missed by the combination of endometrial sampling and ultrasound; 3. Comparison of the quality of tissue obtained for histology by outpatient endometrial sampling and inpatient curettage; and 4. An evaluation of patient acceptability of outpatient and inpatient procedures.
Results 1. A combination of transvaginal sonography, Pipelle endometrial biopsy and outpatient hysteroscopy has similar efficacy to inpatient hysteroscopy and curettage for the investigation of abnormal uterine bleeding; 2. Hysteroscopy will detect some fibroids and polyps missed by a combination of transvaginal ultrasound and Pipelle endometrial sampling; 3. The quality of histological samples obtained by outpatient Pipelle were comparable to those obtained by formal inpatient curettage; and 4. Outpatient procedures were well tolerated, with good patient acceptability.
Conclusion Transvaginal sonography and endometrial biopsy can safely be used as the initial investigations in the management of abnormal uterine bleeding. Hysteroscopy can be used as a second line investigation. Outpatient hysteroscopy with local anaesthesia is well tolerated although general anesthesia may occasionally be necessary.     

A randomised controlled trial comparing transvaginal ultrasound, outpatient hysteroscopy and endometrial biopsy with inpatient hysteroscopy and curettage

OBJECTIVE: To compare the use of outpatient and inpatient procedures in the investigation of abnormal uterine bleeding. DESIGN: A randomised controlled trial. SETTING: Two university teaching hospitals. PARTICIPANTS: Four hundred women with abnormal uterine bleeding (postmenopausal bleeding, menorrhagia, intermenstrual bleeding, postcoital bleeding, or irregular periods) above the age of 35 years, between June 1993 and January 1995. MAIN OUTCOME MEASURES: 1. Incidence of detection of abnormal pathology by vaginal ultrasound, outpatient hysteroscopy and endometrial biopsy compared with inpatient hysteroscopy and curettage; 2. Number of 'lesions' (e.g. fibroids, polyps, endometrial hyperplasia or malignancy) found by hysteroscopy that would have been missed by the combination of endometrial sampling and ultrasound; 3. Comparison of the quality of tissue obtained for histology by outpatient endometrial sampling and inpatient curettage; and 4. An evaluation of patient acceptability of outpatient and inpatient procedures. RESULTS: 1. A combination of transvaginal sonography, Pipelle endometrial biopsy and outpatient hysteroscopy has similar efficacy to inpatient hysteroscopy and curettage for the investigation of abnormal uterine bleeding; 2. Hysteroscopy will detect some fibroids and polyps missed by a combination of transvaginal ultrasound and Pipelle endometrial sampling; 3. The quality of histological samples obtained by outpatient Pipelle were comparable to those obtained by formal inpatient curettage; and 4. Outpatient procedures were well tolerated, with good patient acceptability. CONCLUSION: Transvaginal sonography and endometrial biopsy can safely be used as the initial investigations in the management of abnormal uterine bleeding. Hysteroscopy can be used as a second line investigation. Outpatient hysteroscopy with local anaesthesia is well tolerated although general anesthesia may occasionally be necessary.     

A double-blind randomized trial comparing the Cavaterm and the NovaSure endometrial ablation systems for the treatment of dysfunctional uterine bleeding

OBJECTIVE: To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. DESIGN: A double-blind, randomized trial. SETTING: A minimal access gynecological surgery unit in northeast England. PATIENT(S): Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. INTERVENTION(S): Thirty-seven women underwent a NovaSure endometrial ablation, and 18 had a Cavaterm endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. MAIN OUTCOME MEASURE(S): Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. RESULT(S): Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm and Novasure groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm or Novasure groups, respectively. There were no major complications in either group. CONCLUSION(S): Both the Cavaterm and the Novasure endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure system achieved a statistically significantly higher rate of amenorrhea in this study.     

Clinical evaluation of the Pipelle endometrial suction curette for timed endometrial biopsies

A clinical study was performed to determine the efficacy of the Pipelle in obtaining endometrial samples to be analyzed for luteal function. Patients' tolerance of this instrument and their willingness to undergo subsequent biopsies were also ascertained. An endometrial sample was obtainable from 1,278 women with the Pipelle, whereas 52 required the Novak curette and in 60 the sample could not be obtained with either instrument. Thirteen percent of the patients biopsied with the Pipelle stated that they would not allow a second such procedure to be performed. One percent of the samples were deemed inadequate for hormonal reading. The Pipelle seemed to be a safe, minimally traumatic method of sampling the endometrium for hormonal evaluation.     

A randomised controlled trial comparing outpatient versus daycase endometrial polypectomy

OBJECTIVE: To evaluate outpatient versus daycase endometrial polypectomy by comparing success rate, complications, patient tolerance, pain score, analgesia requirement and recovery. DESIGN: A randomised controlled trial. SETTING: A large UK Teaching hospital. POPULATION: Forty consecutive women diagnosed with an endometrial polyp at outpatient hysteroscopy were randomly assigned in equal proportions to outpatient or daycase polyp removal. METHODS: The outpatient cohort underwent endometrial polypectomy either using grasping forceps or a bipolar electrode (Versapoint; Gynecare Inc., Menlo Park, CA, USA) introduced down the operating channel of a rigid hysteroscope (Versascope; Gynecare Inc.). The daycase cohort underwent traditional endometrial polyp resection using a hysteroscopic, monopolar, electrosurgical resecting loop, performed under general anaesthetic. MAIN OUTCOME MEASURES: The main outcome measures were as follows: success rates and intra or postoperative complications, time away from home, analgesia requirements, pain scores on the day of and one day after endometrial polypectomy, return to work and preoperative fitness and preference for the location of a future endometrial polypectomy. RESULTS: The majority of women from both cohorts were premenopausal (62.5%), parous (85%) and in paid employment (62.5%). One woman allocated to outpatient polypectomy had cervical stenosis and dilatation was unsuccessful in the outpatient setting. There were no other intra or postoperative complications in either arm of the study. The mean intraoperative visual analogue style (0-100 mm) pain score during outpatient polypectomy was 23.7 mm (1-62). A proportion of women (20%) described no intraoperative discomfort; however, the majority (75%) described mild or moderate intraoperative discomfort. More women in the outpatient cohort (58%) described themselves as pain free for the remainder of the day than in the daycase cohort (28%) (P= 0.09). The day after the procedure, all women from the outpatient group described slight or no discomfort compared with only 41% of women from the daycase group (P= 0.02). All women undergoing outpatient polypectomy had a significantly shorter mean time away from home (3.24 [1.5-5] hours) than women undergoing daycase polypectomy (7.42 [6-10.5] hours), P < 0.0005. Similarly, women from the outpatient cohort had a significantly faster mean return to preoperative fitness (1 [0-4] day versus 3.2 [1-13] days; P= 0.001) and required less postoperative analgesia than the daycase cohort. Ninety-five percent of women from the outpatient cohort and 82% of women from the daycase cohort stated they would prefer to undergo an endometrial polypectomy in the outpatient setting should they require a further polyp removal. CONCLUSION: Endometrial polypectomy can be successfully performed in the outpatient setting with minimal intraoperative discomfort, a significantly shorter time away from home and faster recovery and is preferred by women when compared with daycase polypectomy. Resources need to be made rapidly available to undertake larger scale research and develop this service across the UK.     

A randomized clinical trial comparing primary overlap with approximation repair of third-degree obstetric tears

OBJECTIVE: We compared, in a prospective, randomized clinical trial, the subjective and objective outcomes after primary anal sphincter overlap or approximation repair of third-degree obstetric tears. STUDY DESIGN: In a prospective, randomized clinical trial at our university teaching hospital, we studied 112 primiparous women who sustained a third-degree tear during a 1-year period (July 1998-June 1999); they were randomly selected, at diagnosis, to receive either an overlap or an approximation repair. Obstetric personnel, trained in both methods, carried out the repairs immediately after delivery. Fifty-five women underwent an overlap procedure, and 57 women underwent an approximation repair. Outcome measures assessed were symptoms of fecal incontinence, abnormal findings on anal manometry, and abnormal findings on endoanal ultrasonography at 3 months post partum. RESULTS: Obstetric factors, including mode of delivery, birth weight, duration of labor, and episiotomy incidence, did not differ significantly between the 2 groups. Experience of the operator, analgesia used, and place of repair were similar in both groups. The median incontinence scores were 0/20 after overlap repair and 2/20 after approximation repair (difference not significant). Eleven women (20%) complained of fecal urgency after overlap repair, in comparison with 17 (30%) after approximation repair (difference not significant). There were no significant differences in either anal manometry or endoanal ultrasonographic results between the 2 groups. Six women (11%) had a significant (>1 quadrant) anal sphincter defect after primary overlap repair, compared with 3 (5%) after approximation repair (difference not significant). Overall, 66% of women had ultrasonographic evidence of a residual full-thickness defect in the external anal sphincter after primary repair. CONCLUSION: The outcome after primary repair of third-degree obstetric tear was similar whether an approximation or an overlap technique was used. Overall symptomatic outcome was good, although two thirds of women had ultrasonographic evidence of residual anal sphincter damage irrespective of the method of repair.     

A randomized clinical trial comparing embryo culture in a conventional incubator with a time-lapse incubator

Purpose

Time-lapse monitoring allows for a flexible embryo evaluation and potentially provides new dynamic markers of embryo competence. Before introducing time-lapse monitoring in a clinical setting, the safety of the instrument must be properly documented. Accordingly, the aim of this study was to evaluate the safety of a commercially available time-lapse incubator.

Methods

In a two center, randomized, controlled, clinical trial 676 oocytes from 59 patients in their 2nd or third treatment cycle, age <38 years and ≥8 oocytes retrieved were cultured in the time-lapse incubator or in a conventional incubator. The primary outcome was proportion of 4-cell embryos on day 2. Secondary outcomes were proportion of 7–8 cell embryos on day 3 and proportion of blastocysts on day 5. Implantation pregnancy rates were registered based on presence of fetal heart activity visualized by ultrasound 8 weeks after embryo transfer.

Results

No significant difference was found between the time-lapse incubator (TLI) and conventional incubator (COI) in proportion of 4-cell embryos on day 2 irrespective of whether data was analyzed according to ITT (RR_TLI/COI: 0.81 (0.65; 1.02)) or PP (RR_TLI/COI: 0.80 (0.63; 1.01)). Nor were any significant differences detected in the secondary endpoints; i.e. proportion of 7–8-cell embryos on day three ITT (RR_TLI/COI: 0.96 (0.73; 1.26)); PP (RR_TLI/COI: 0.95 (0.72; 1.26)) and proportion of blastocysts on day five ITT (RR_TLI/COI: 1.09 (0.84; 1.41)); PP (RR_TLI/COI: 1.09 (0.83: 1.41)). We found no differences in clinical pregnancy rate or implantation rate.

Conclusion

Culture in the time-lapse incubator supports embryonic development equally to a conventional incubator.