Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study.

BACKGROUND: Insufflation of the abdomen during laparoscopy improves surgical space, but may cause post-operative shoulder pain. The incidence of shoulder pain is reduced using a lower insufflation pressure, but this may, however, compromise the surgical space. We aimed at investigating whether deep neuromuscular blockade (NMB) would enlarge surgical space, measured as the distance from the sacral promontory to the trocar in patients undergoing gynaecologic laparoscopy. METHODS: Fourteen patients were randomised in an assessor-blinded crossover design. The distance from the sacral promontory to the trocar was measured during deep NMB and without NMB at pneumoperitoneum 8 and 12 mmHg both. Additionally, we assessed surgical conditions while suturing the abdominal fascia using a 4-point subjective rating scale. Deep NMB was established with rocuronium and reversed with sugammadex. RESULTS: At 12 mmHg pneumoperitoneum, deep NMB improved surgical space with a mean of 0.33 cm (95% confidence interval 0.07-0.59) (P=0.01, paired t-test) compared with no NMB. At 8 mmHg pneumoperitoneum deep NMB improved surgical space with a mean of 0.3 cm (95% confidence interval, 0.06-0.54) (P=0.005) compared with no NMB. Deep NMB resulted in significantly better ratings of surgical conditions during suturing of the fascia (P=0.03, Mann-Whitney U-test). CONCLUSION: Deep NMB enlarged surgical space measured as the distance from the sacral promontory to the trocar. The enlargement, however, was minor and the clinical significance is unknown. Moreover, deep NMB improved surgical conditions when suturing the abdominal fascia.

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

OBJECTIVE: To compare the impact of 1000 microg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy. DESIGN: Randomised, double-blind, placebo-controlled sequential trial. SETTING: Norwegian university teaching hospital. POPULATION: Sixty-seven postmenopausal women referred for day-care operative hysteroscopy. METHODS: The women were randomised to receive either 1000 microg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-microg vaginal estradiol tablet daily for 14 days prior to the operation. PRIMARY OUTCOME: preoperative cervical dilatation at hysteroscopy. SECONDARY OUTCOMES: difference in dilatation at recruitment and before hysteroscopy, number of women who achieved a preoperative cervical dilatation of 5 mm or more, acceptability, complications and adverse effects. RESULTS: The mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2-1.7 mm). Self-administered vaginal misoprostol of 1000 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain. CONCLUSIONS: One thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.

Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group.

The IETA (International Endometrial Tumor Analysis group) statement is a consensus statement on terms, definitions and measurements that may be used to describe the sonographic features of the endometrium and uterine cavity on gray-scale sonography, color flow imaging and sonohysterography. The relationship between the ultrasound features described and the presence or absence of pathology is not known. However, the IETA terms and definitions may form the basis for prospective studies to predict the risk of different endometrial pathologies based on their ultrasound appearance.

Long-term outcomes following laparoscopic supracervical hysterectomy.

OBJECTIVE: Evaluation of long-term outcomes following laparoscopic supracervical hysterectomy (LSH). DESIGN: Retrospective postal questionnaire. SETTING: Norwegian university teaching hospital. POPULATION: A total of 315 consecutive patients. METHODS: A questionnaire sent to all patients who underwent a LSH during 2004 and 2005. MAIN OUTCOME MEASURES: Persistent vaginal bleeding and pelvic pain, patient acceptability of such symptoms and patient satisfaction following LSH. RESULTS: A total of 240 women (78%) completed the questionnaire. About 24% reported experiencing vaginal bleeding up to 3 years following their hysterectomy, although this was rated as minimal in 90% of cases, resulting in a mean bothersome score of 1.1 (SD 2.0) on a 10-point visual analogue scale (VAS). Women operated on by less experienced surgeons were more likely to report vaginal bleeding following surgery (P = 0.02). About 74% of women reported having menstrual pain prior to surgery, with a mean score of 6.8 (SD 2.1) (10-point VAS). Up to 3 years following surgery, 38% continued to experience menstrual pain, although this was significantly less intense with a mean score of 3.5 (SD 2.2) (P < 0.01). While all women reported a decrease in the amount of pain experienced following the hysterectomy, those having a hysterectomy because of endometriosis reported significantly higher levels of menstrual/cyclical pain after surgery compared with women who had a hysterectomy for other reasons (P < 0.01). Ninety per cent of women reported being satisfied with their surgery. CONCLUSION: Although vaginal bleeding and pelvic pain are frequently observed following LSH, these symptoms are significantly reduced and patient satisfaction is high.

Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design.

OBJECTIVE: To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy. DESIGN: Two separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95. SETTING: Norwegian university teaching hospital. SAMPLE: Eighty-six women referred to outpatient operative hysteroscopy. METHODS: The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient operative hysteroscopy. MAIN OUTCOME MEASURES: Preoperative cervical dilatation (primary outcome), number of women who achieve a preoperative cervical dilatation > or = 5 mm, acceptability, complications and adverse effects (secondary outcomes). RESULTS: In premenopausal women, the mean cervical dilatation was 6.4 mm (SD 2.4) in the misoprostol group and 4.8 mm (SD 2.0) in the placebo group, the mean difference in cervical dilatation being 1.6 mm (95% CI 0.5-2.7). Among the premenopausal women receiving misoprostol, 88% achieved a cervical dilatation of > or = 5 mm compared with 65% in the placebo group. Twelve percent of the women who received misoprostol were difficult to dilate compared with 32% who received placebo. Dilatation was also quicker in the misoprostol group. Misoprostol had no effect on cervical ripening in postmenopausal women compared with placebo, and 43% of the women were difficult to dilate. The trials were terminated after analysis of 21 postmenopausal women and 65 premenopausal women after reaching a conclusion on the primary outcome with only 28% of the number of women needed in a fixed sample size trial. Three of 45 women who received misoprostol experienced severe lower abdominal pain, and there was an increased occurrence of light preoperative bleeding in the misoprostol group. Most women did not experience misoprostol-related adverse effects. The majority (83% of premenopausal and 76% of postmenopausal women) found self-administered vaginal misoprostol at home to be acceptable. There were two serious complications in the premenopausal misoprostol group: uterine perforation with subsequent peritonitis and heavy postoperative bleeding requiring blood transfusion, but these were not judged to be misoprostol related. Complications were otherwise comparatively minor and distributed equally between the two dosage groups. CONCLUSIONS: One thousand micrograms of self-administered vaginal misoprostol 12 hours prior to operative hysteroscopy has a significant cervical ripening effect compared with placebo in premenopausal but not in postmenopausal women. Self-administered vaginal misoprostol of 1000 micrograms at home the evening before operative hysteroscopy is safe and highly acceptable, although a small proportion of women experienced severe lower abdominal pain. There is a risk of lower abdominal pain and light preoperative bleeding with this regimen, which is very cheap and easy to use.

Does self-administered vaginal misoprostol result in cervical ripening in postmenopausal women after 14 days of pre-treatment with estradiol? Trial protocol for a randomised, placebo-controlled sequential trial.

OBJECTIVE: To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after pre-treatment with estradiol vaginal tablets at home in postmenopausal women prior to day-care operative hysteroscopy. DESIGN: Randomised double-blind placebo-controlled sequential trial. The boundaries for the sequential trial were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 millimetre, with the assumption of a type 1 error of 0.05 and a power of 0.95. SETTING: Norwegian university teaching hospital. POPULATION: Postmenopausal women referred for day-care operative hysteroscopy. METHODS: The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before day-care operative hysteroscopy. All women had administered a 25-microgram vaginal estradiol tablet daily for 14 days prior to the operation. MAIN OUTCOME MEASURES: Preoperative cervical dilatation (difference between misoprostol and placebo group, primary outcome), difference in dilatation before and after administration of misoprostol or placebo, number of women who achieve a preoperative cervical dilatation > or = 5 millimetres, acceptability, complications and side effects (secondary outcomes). RESULTS: Intra-operative findings and distribution of cervical dilatation in the two treatment groups: values are given as median (range) or n (%). Difference in dilatation before and after administration of misoprostol and placebo: values are given as median (range) of intraindividual differences. Percentage of women who achieve a cervical dilatation of > or = 5 mm, percentage of women who were difficult to dilate. Acceptability in the two treatment groups: values are given as completely acceptable n (%), fairly acceptable n (%), fairly unacceptable n (%), completely unacceptable n (%). Pain in the two treatment groups: pain was measured with a visual analogue scale ranging from 0 (no pain) to 10 (unbearable pain): values are given as median (range). Occurrence of side effects in the two treatment groups. Values are given as n (%). Complications given as n (%). FUNDING SOURCES: No pharmaceutical company was involved in this study. A research grant from the regional research board of Northern Norway has been awarded to finance Dr K.S.O.'s leave from Hammerfest hospital as well as travel expenses between Hammerfest and Oslo, and research courses. The research grant from Prof B.I.N. (Helse Øst) funded the purchase of estradiol tablets, the manufacturing costs of misoprostol and placebo capsules from the hospital pharmacy, as well as the costs incurred for preparing the randomisation schedule and distribution of containers containing capsules to hospital. Prof B.I.N.'s research grant also funded insurance for the study participants. CONCLUSIONS: Estimated completion date 31 December 2008.

Flow differences between endometrial polyps and cancer: a prospective study using intravenous contrast-enhanced transvaginal color flow Doppler and three-dimensional power Doppler ultrasound.

OBJECTIVES: To evaluate whether assessment of blood flow by transvaginal color Doppler and three-dimensional power Doppler imaging, enhanced by intravenous contrast, may be useful in the differentiation between benign endometrial polyps and endometrial cancer. METHODS: A prospective study was performed comparing 17 women with benign endometrial polyps and 17 women with endometrial cancer. Transvaginal color Doppler and three-dimensional power Doppler angiography were performed before and after injection of intravenous contrast. The pulsatility index (PI) and the resistance index (RI) of the polyp feeding vessel or central vessel in malignant lesions, as well as the power Doppler endometrial flow indices vascularization index (VI), flow index (FI) and vascularization flow index (VFI), were calculated before and after enhancement by contrast, and compared between the two groups of women. RESULTS: PI (mean difference +/- SD, 0.68 +/- 0.22; 95% CI, 0.23-1.13; P = 0.004) and RI (mean difference +/- SD, 0.16 +/- 0.08; 95% CI, 0.00-0.32; P = 0.045) were significantly lower in vessels of malignant tumors than in those of benign endometrial polyps after enhancement by intravenous contrast. No significant differences in PI, RI, VI, FI or VFI before enhancement by contrast, or in VI, FI or VFI after enhancement by contrast, were detected between women with endometrial polyps and those with endometrial cancer. CONCLUSIONS: Transvaginal color Doppler examination enhanced by intravenous contrast may help to discriminate between benign endometrial polyps and cancer. Larger studies are required to confirm these findings.

Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design.

OBJECTIVE: To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy. DESIGN: Randomised, double-blind, placebo-controlled sequential trial. SETTING: Norwegian university teaching hospital. SAMPLE: Premenopausal and postmenopausal women referred to outpatient resectoscopy. METHODS: The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy. MAIN OUTCOME MEASURES: Preoperative cervical dilatation, acceptability and complications. RESULTS: (a) Intraoperative findings and distribution of cervical dilatation in the two treatment groups. Values are given as median (range) or n (%). (b) Acceptability in the two treatment groups. Values are given as completely acceptable, n (%); fairly acceptable, n (%); fairly unacceptable, n (%) and completely unacceptable, n (%). (c) Pain in the two treatment groups. Pain was measured with a visual analogue scale score, scale ranges from 0 (no pain) to 10 (unbearable pain). Values are given as median (range). (d) Occurrence of adverse effects in the two treatment groups. Values are given as n (%). (e) Complications, given as n (%).

Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with use of glycine 1.5% for uterine irrigation.

OBJECTIVE: We evaluated the postoperative changes in serum electrolytes in relation to the amount of irrigating fluid absorption and the occurrence of nausea and vomiting after transcervical resection of endometrium and submucous fibroids. METHODS: From May 1989 to October 1991, 101 consecutive patients were operated on for menometrorrhagia with transcervical resection of endometrium and submucous fibroids using glycine 1.5% for uterine irrigation. The deficit of glycine was assessed during and at the end of the operation. During the postoperative course, attention was paid to the occurrence of cerebral confusion, nausea (defined by at least one incident of vomiting), and dyspnea. The serum levels of sodium, potassium, and chloride were assessed before the operation, at the end of the procedure, and after 4, 8, and 12 hours. RESULTS: No marked water intoxication or signs of volume overload were seen, but 33% of the patients had nausea and vomiting in the postoperative period. These patients showed a more pronounced postoperative decrease in serum sodium (P = .0001) and a larger glycine deficit (P = .004) than did patients without nausea. The postoperative decrease in serum sodium correlated significantly to the glycine deficit (R2 = 0.83, P less than .001). CONCLUSION: Postoperative hyponatremia after transcervical resection of the endometrium correlated with the deficit of irrigant fluid but not with the operation time or the total amount of irrigant fluid used. We recommend that serum sodium be controlled and corrected if necessary postoperatively in patients with nausea and vomiting.

Hormone replacement therapy after transcervical resection of the endometrium.

OBJECTIVE: To determine if women who have undergone transcervical resection of the endometrium can be treated safely with estrogens alone. METHODS: Sixty-two postmenopausal women who had undergone endometrial resection were recruited into a double-blind, randomized study. Twenty-one had menopausal symptoms at the primary operation and were recruited at the time of the surgery, and 38 were recruited an average of 20 months (range 8-42) after the primary endometrial resection and underwent a second resection to remove any residual endometrium before entering the study. Three patients were excluded from the study. Subjects were allocated randomly to one of two hormone replacement therapy (HRT) regimens: 17-beta-estradiol 2 mg alone or combined with norethisterone 1 mg. Clinical and ultrasound data were collected every 3 months. Hysteroscopically standardized endometrial biopsies were taken after 1 year. RESULTS: In the single-agent therapy group, endometrial hyperplasia without atypia was found in six subjects and proliferative endometrium in eight after 1 year. No such cases occurred among women receiving combined therapy. Endometrial thickness and menstrual bleeding were significantly greater in the single-agent therapy group than in those receiving combined therapy. These differences between single-agent and combined therapy were statistically significant. CONCLUSION: Postmenopausal HRT in patients who have undergone transcervical resection of the endometrium should include progestagen for protection of the endometrium.

Treatment of menorrhagia with the levonorgestrel intrauterine system versus endometrial resection.

OBJECTIVE: Treatment of menorrhagia with levonorgestrel intrauterine system (LNG IUS) and transcervical resection. DESIGN: An open, therapeutic, randomized study. SETTING: Central county hospital specializing in hysteroscopy. PATIENT(S): Two parallel groups of 30 subjects each. INTERVENTION(S): Thirty patients had a LNG IUS inserted within the first 7 days of menses; 29 patients underwent endometrial resection. MAIN OUTCOME MEASURE(S): A 12-month follow-up of menstrual blood loss and adverse events were evaluated. RESULT(S): LNG IUS group: 13 patients reported one or more pelvic adverse events, bleeding disorders (n = 6), abdominal pain (n = 4), breast tenderness (n = 3), headache, acne (n = 2), and mood changes (n = 1). Six patients discontinued treatment because of irregular bleeding (n = 3), pain (n = 2), and acne (n = 1). In both groups, general feeling of genital health increased with Visual Analogue Scale score. Nine patients reported adverse events. This included pelvic pain indicating inflammation (n = 4), bleeding (n = 3), vaginitis (n = 1), and ulceration (n = 1). Treatment success at 12 months was achieved in 20 (67%) of the 30 patients in the LNG IUS group and in 26 (90%) of the 29 patients in the transcervical resection group. Adverse events were more often reported in the LNG IUS group. CONCLUSION(S): Both treatments effectively reduced the menstrual blood loss. Furthermore, the LNG IUS treatment is reversible and has no operative hazards.

The incidence of fallopian tube patency after transcervical resection of the endometrium including rollerball diathermy to the tubal ostia.

OBJECTIVE: To evaluate the incidence of tubal patency as well as the shape of the endometrial cavity after transcervical resection of the endometrium. DESIGN: An open observational trial. SETTING: The obstetrics and gynecology unit at a district hospital in Norway. PATIENTS: Fifty consecutive patients who had undergone treatment for menorrhagia and metrorrhagia by resection of the endometrium and coagulation of the tubal ostium were included in the study. INTERVENTION: A hysterosalpingogram was performed with a semistiff catheter and injection of 20 mL contrast dye 5 to 12 months after transcervical resection of the endometrium and fibroids. MAIN OUTCOME MEASURES: Tubal patency and uterine cavity morphology. RESULTS: Forty-four patients showed total occlusion of the fallopian tubes, and the uterine cavity showed fibrosis and narrowing of the cavity. Three patients showed bilateral and three patients unilateral tubal patency. CONCLUSION: Shrinkage and fibrosis of the uterine cavity occur after endometrial resection. A significant number of women after transcervical resection of the endometrium have patient tubes (13%) despite coagulation of the tubal ostia.

Goserelin acetate (Zoladex) plus endometrial ablation for dysfunctional uterine bleeding: a 3-year follow-up evaluation.

OBJECTIVE: To report the results of a 3-year follow-up evaluation of a trial comparing goserelin acetate depot injections with sham injections before endometrial ablation for the treatment of dysfunctional uterine bleeding (DUB). DESIGN: Prospective, randomized, double-blind, parallel-group study. SETTING: Thirty-seven centers in 12 countries. PATIENT(S): Three-hundred and fifty-eight premenopausal women aged over 30 years with DUB. INTERVENTION(S): Goserelin acetate (3.6 mg depot) every 28 days for 8 weeks, or sham depot every 28 days for 8 weeks, with endometrial ablation 6 weeks +/- 3 days after the first depot injection (i.e., when the endometrium is at its thinnest). The follow-up continued for 3 years. MAIN OUTCOME MEASURE(S): At the 3-year follow-up, bleeding in the previous 3 months and need for surgical intervention were recorded. RESULT(S): At 3 years, amenorrhea rates were 21% in the goserelin acetate group and 14% in the control group (estimated odds ratio, 1.8; 95% CI, 0.98-3.25; P=.0571). The surgical intervention rate (since the original procedure) was low and did not differ significantly between groups. For hysterectomy, it was 21% for the goserelin acetate group and 15% for the control group. For repeat ablations, it was 5.6% for the goserelin acetate group and 2.1% for the control group. CONCLUSION(S): Prethinning with goserelin acetate before endometrial ablation resulted in higher long-term amenorrhea rates than ablation without prethinning.

Transcervical resection of endometrium and fibroids: the outcome of 412 operations performed over 5 years.

OBJECTIVE: To evaluate the value of transcervical resection of endometrium and fibroids in clinical practice. STUDY DESIGN: A retrospective review of operative details of 412 transcervical resections of endometrium and fibroids and clinical outcome from 387 procedures performed over five years is reported. MATERIAL AND METHODS: Patients referred due to bleeding disturbance, treated with a standard urological resectoscopes, controlled after 6 and 12 months. Subsequent follow up was performed by questionnaire and patient bleeding diary. RESULTS: Operative complications (perforation, hemorrhage, absorption and more than 1500 ml glycine irrigating fluid) arose in 72 patients (18%). In 52 (14.4%) of 366 patients the outcome was not considered acceptable by either ourselves or the patients. This led to a repeat resection procedure being performed in 31 cases (9.0%) with favorable result in 21 (68%) of these cases. Twenty-one patients (6.1%) underwent a hysterectomy because of a persistently poor outcome. A favorable outcome was then reported in subsequent follow up of 335 patients (91%). In addition, pain associated with menstruation was reduced after the procedure and correlates with achieved result on bleeding intensity. CONCLUSION: Endometrial resection is safe and acceptable treatment option for both menorrhagia and metrorrhagia associated with dysmenorrhoea.

[Transcervical resection of endometrium and myomas in women with bleeding disorders]. / Transcervikal reseksjon av endometrium og myomer hos kvinner med blødningsforstyrrelser.

Recently hysteroscopic resection of the endometrium and of fibroids has become an alternative to hysterectomy. This treatment preserves the uterus, the equipment is cheap and outpatient treatment is possible. 32 patients were treated with resection of the endometrium and 18 patients with resection fibroids. 23 patients have been followed up for a period of at least six months. Out of these, eight patients became amenorhoic and 15 experienced a more than 50% reduction in the use of sanitary pads. In conclusion, transcervical resection of the endometrium and of fibroids is a useful and a promising alternative in the treatment of the common complaint of meno/metroragia.