Lesion-to-anal-verge distance in rectosigmoid endometriosis on transvaginal sonography vs magnetic resonance imaging: prospective study.

OBJECTIVES: To compare transvaginal sonography (TVS) and magnetic resonance imaging (MRI) with intraoperative measurement (IOM) using a rectal probe in the estimation of the location of rectosigmoid endometriotic lesions, i.e. lesion-to-anal-verge distance (LAVD), and to compare two different MRI techniques for measuring LAVD. METHODS: This was a prospective single-center observational study that included women undergoing surgery for symptomatic rectosigmoid endometriosis by discoid (DR) or segmental (SR) resection from December 2018 to December 2019. TVS and MRI were performed presurgically for each participant to evaluate LAVD, and the measurements on imaging were compared with IOM using a rectal probe. Clinically acceptable difference and limits of agreement (LoA) between TVS and MRI compared with IOM were set at ± 20 mm. Two different measuring methods for MRI, MRICenter and MRIDirect , were proposed and evaluated, as there is currently no guideline to describe deep endometriosis on MRI. Bland-Altman plots and LoA were used to assess agreement of TVS and both MRI methods with IOM. Systematic and proportional biases were assessed using paired t-test and Bland-Altman plots. RESULTS: Seventy-five women were eligible for inclusion. Twenty-eight women were excluded, leaving 47 women for the analysis. Twenty-three DR and 26 SR procedures were performed, with both procedures performed in two women. The Bland-Altman plots showed that there were no systematic differences between TVS or MRICenter when compared with IOM for all included participants. MRIDirect systematically underestimated LAVD for lesions located further from the anal verge. TVS, MRICenter and MRIDirect had LoA outside the preset clinically acceptable difference when compared with IOM. LAVD was within the clinically acceptable difference from IOM of ± 20 mm in 70% (33/47) of women on TVS, 72% (34/47) of women on MRICenter and 47% (22/47) of women on MRIDirect . CONCLUSIONS: TVS should be the preferred method to estimate the location of a rectosigmoid endometriotic lesion, i.e. LAVD, as it is more available, less expensive and has a similar accuracy to that of MRI. Estimating LAVD can be relevant for planning colorectal surgery for rectosigmoid endometriosis. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Transvaginal sonography determines accurately extent of infiltration of rectosigmoid deep endometriosis.

OBJECTIVE: To investigate the agreement of measurements of the three diameters of rectosigmoid deep endometriosis (DE) lesions between presurgical evaluation using transvaginal sonography (TVS) and postsurgical specimen measurement (PSM). METHODS: This was a prospective observational multicenter study including symptomatic women undergoing surgical treatment for DE involving the rectosigmoid, by either discoid or segmental resection, from April 2017 to December 2019. TVS was performed presurgically to evaluate lesion size (craniocaudal-midsagittal length, anteroposterior thickness and transverse diameter), in accordance with the International Deep Endometriosis Analysis (IDEA) group consensus statement, and was compared with PSM. The agreement of lesion dimensions between the two methods was assessed by Bland-Altman plots and limits of agreement and additionally by the intraclass correlation coefficient (ICC) and Pearson's correlation coefficient. Systematic and proportional bias was assessed using the paired t-test. RESULTS: A total of 207 consecutive women were eligible for inclusion. Forty-one women were excluded, leaving 166 women for final analysis. A total of 123 segmental resections and 46 discoid resections were performed (both procedures were performed in three women). The mean difference between TVS and PSM was 0.90 (95% CI, 0.85-0.95) mm for lesion length measurements, 1.03 (95% CI, 0.98-1.09) mm for lesion thickness measurements and 0.84 (95% CI, 0.79-0.89) mm for transverse diameter measurements. Bland-Altman analysis demonstrated good agreement between the two methods for measurements of lesion length. Furthermore, there was good reliability and correlation between TVS and PSM for lesion length measurements, as demonstrated by an ICC of 0.82 (95% CI, 0.75-0.87) and Pearson's correlation coefficient of 0.72 (95% CI, 0.62-0.80), moderate-to-good reliability and correlation for lesion thickness measurements, with an ICC of 0.76 (95% CI, 0.67-0.82) and Pearson's correlation coefficient of 0.61 (95% CI, 0.51-0.70), and poor-to-moderate reliability and correlation for transverse diameter measurements, with an ICC of 0.58 (95% CI, 0.39-0.71) and Pearson's correlation coefficient of 0.46 (95% CI, 0.33-0.58). CONCLUSION: Preoperative TVS determines accurately rectosigmoid DE lesion length. TVS can thereby contribute to optimal planning of surgical treatment options in women with rectosigmoid DE. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Changes in route of hysterectomy in Norway since introduction of robotic approach.

INTRODUCTION: From 2008, several Norwegian Health Trusts have acquired surgical robotic systems, and robotic hysterectomy accounted for 15 % of all hysterectomies performed in Norway in 2018. Robotic assisted hysterectomy is costly, and there is no evidence that the clinical outcome of robotic assisted hysterectomy is superior compared to the outcomes following other minimal invasive hysterectomies such as vaginal and laparoscopic hysterectomies. The objectives of this study were to describe the implementation of robotic hysterectomy and changes in other hysterectomy approaches, such as open abdominal, laparoscopic and vaginal hysterectomy in hospitals with and without robotic systems for hysterectomy. METHODS: Quantitative study based on hysterectomy data between 2010 to 2018 from the Norwegian Patient Registry. RESULTS: 9 out of 19 health trusts performed robotic assisted hysterectomy during the study period. The rate of abdominal hysterectomies declined during the study period, both in the health trusts with and without available surgical robotic systems. The rate of other minimally invasive hysterectomies also declined in some health trusts after the implementation of robotic assisted hysterectomy. DISCUSSION: Robotic hysterectomy has been implemented and is increasing in Norway without a thorough evaluation of the effect on patient safety and possible economic consequences. According to our findings, it appears that the implementation of robotic hysterectomy has not had a significant impact on the use of open abdominal hysterectomy. Although associated with increased costs and a lack of evidence of improved clinical outcomes for women, robotic hysterectomy has furthermore to some extent replaced other minimal invasive hysterectomies.

Development and validation of a curriculum for laparoscopic supracervical hysterectomy.

STUDY OBJECTIVE: To develop and validate a three-step curriculum for laparoscopic supracervical hysterectomy (LSH) designed for a busy clinical setting. NETHODS: Single-centre, prospective, cohort study. Twelve eligible gynaecological trainees were included (group 1). The theoretical part (step 1) was a validated multiple-choice test. The practical part (step 2) consisted of five tasks on a virtual reality simulator. The participants had to reach a pre-defined proficiency level before advancing to performing a LSH (step 3). The validation of the curriculum was based on the surgical performance. The surgical procedure was recorded and assessed by two experts using Global Operative Assessment of Laparoscopic Skills (GOALS) and Competence Assessment Tool - Laparoscopic Supracervical Hysterectomy (CAT-LSH). The scores were compared with scores from gynaecological trainees who performed their first LSH without virtual reality simulator training (group 2). RESULTS: Ten trainees completed the curriculum and performed a LSH that was recorded and evaluated. Mean duration of the training period (step 1 and 2) was 57 days (SD 26.0), and mean training time spent on the simulator to reach the pre-set proficiency level was 173 min (SD 49). The mean GOALS score was 18.5 (SD 5.8) in group 1 and 13.6 (SD 3.3) in group 2, p=0.027. The mean CAT-LSH score of the performance of the hysterectomy was 42.1 (SD 6.9) in group 1 and 34.8 (SD 4.3) in group 2, p= 0.009. CONCLUSIONS: Trainees who completed the curriculum appeared to have a higher performance score compared with trainees who did not perform structured training.

Transvaginal sonography accurately measures lesion-to-anal-verge distance in women with deep endometriosis of the rectosigmoid.

OBJECTIVES: First, to investigate the accuracy of transvaginal sonography (TVS) for presurgical evaluation of the distance between the most caudal part of the endometriotic lesion and the anal verge (lesion-to-anal-verge distance (LAVD)) in women with rectosigmoid deep endometriosis (DE), compared with intraoperative measurement (IOM). Second, to assess the agreement between anastomosis height and LAVD measured using TVS. METHODS: This was a prospective observational multicenter study of symptomatic women who were scheduled for surgical treatment of rectosigmoid DE, by either discoid or segmental resection, between April 2017 and September 2019. Presurgical TVS was performed to evaluate the LAVD in two ways, depending on the level of the lesion. Method 1: for lesions at the level of the rectovaginal septum (RVS), the caudal part of the lesion was identified on TVS and an index finger was placed on the TVS probe at the level of the anal verge. The probe was withdrawn and the distance from the tip of the TVS probe down to the index finger was measured using a ruler, representing the LAVD. Method 2: for lesions above the RVS, the distance between the caudal part of the lesion and the lower lip of the posterior cervix was measured in a frozen image (LAVD-1), and the distance between the lower lip of the posterior cervix and the anal verge (LAVD-2) was measured using Method 1. These two measurements (LAVD-1 and LAVD-2) were added together and the result represented the total LAVD. During surgery, a rectal probe was used to perform IOM of LAVD, which was considered as the gold standard test. Agreement between LAVD measured using TVS and the IOM was assessed using Bland-Altman analysis. The intraclass correlation coefficient (ICC) for absolute agreement and Spearman's correlation coefficient were also calculated. Systematic and proportional bias were tested for significance using the paired t-test. Similar analysis was performed to assess agreement between LAVD measured using TVS and anastomosis height. RESULTS: A total of 147 consecutive women were considered eligible for inclusion. Fourteen women were excluded initially. Thirty-four discoid resections and 102 segmental resections were performed; both procedures were performed in three women. Two more women were excluded from the final analysis because the measurements represented extreme outliers. The mean LAVD measured using TVS was 114.8 ± 36.5 mm and the mean IOM was 116.9 ± 42.3 mm. There was no statistically significant difference between LAVD measured using TVS and IOM (mean difference, -2.12 mm (95% CI, -6.33 to 2.05 mm); P = 0.32). Bland-Altman analysis showed that there was good agreement between the two methods. The ICC was 0.81 (95% CI, 0.74-0.86) and Spearman's correlation coefficient was 0.68 (95% CI, 0.56-0.77). The mean difference between LAVD measured using TVS and anastomosis height was statistically, but not clinically, significant (mean difference, 10.25 mm (95% CI, 5.94-14.32 mm); P = 0.0005), and the ICC was 0.78 (95% CI, 0.66-0.85). CONCLUSIONS: There is good agreement between the LAVD measured using TVS and the IOM in women with rectosigmoid DE. As a consequence, TVS could be useful for estimation of the height of the final surgical anastomosis in women undergoing full-thickness resection for rectosigmoid DE. This is of pivotal importance in reducing the risk of complications and need for a temporary stoma, and could improve patient counseling. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Development and validation of a general and easy assessable scoring system for laparoscopic skills using a virtual reality simulator.

OBJECTIVES: To develop and validate a scoring system for laparoscopic skills for five specific tasks on a virtual reality simulator. STUDY DESIGN: A longitudinal, experimental, non-randomised study including 30 gynecologists and gynecological trainees at three hospitals. The participants were categorized as inexperienced (Group 1), moderately experienced (Group 2), and experienced (Group 3).The study participants performed ten repetitions of three basic skill tasks, a salpingectomy and a laparoscopic supracervical hysterectomy on a virtual reality simulator. Assessment of skills was based on time, error parameters and economy of movements measured by the simulator. We used the results (mean and SD for each parameter in all tasks) of the four last repetitions performed by the experienced gynecologists as the basic for the scoring system. Performance equal to, and higher than, this mean score gave 2 points. A decrease of 1 SD from the mean gave 1 point. Every score below gave 0 points. The mean score for the inexperienced, moderately experienced and experienced study participants was compared. RESULTS: The mean scores in Task 1 were 3.4 (SD 0.6) in Group 1, 3.4 (SD 0.6) in Group 2 and 5.1 (SD 1.1) in Group 3, respectively. There was a statistically significant difference in score between Group 1 and 3 (p = 0.01), and group 2 and 3 (p = 0.01). In Task 2 no statistical significant differences were found. In Task 3, the total mean scores were 1.7 (SD 0.7) in Group 1, 1.9 (SD 0.9) in Group 2 and 2.8 (SD 0.5) in Group 3, respectively. The difference in score between study groups was statistically significant when comparing Group 1 and Group 3 (p < 0.01) and Group 2 and Group 3 (p = 0.02).In Task 4, the difference in used time between group 1 and 3 was statistically significant (p = 0.03). In task 5 there was a significant difference in performance score between group 1 and 3 (p = 0.01). CONCLUSIONS: There was significant difference in scores between the experienced and the inexperienced gynecologist in four out of five tasks.The scoring system is easy assessable and can be used for summative and formative feedback in proficiency-based assessment.

Pain reduction after total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy among women with dysmenorrhoea: a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of total laparoscopic hysterectomy compared with laparoscopic supracervical hysterectomy for alleviating dysmenorrhoea. DESIGN: Randomised blinded controlled trial. SETTING: Norwegian university teaching hospital. SAMPLE: Sixty-two women with dysmenorrhoea. METHODS: Participants randomised to either total laparoscopic hysterectomy (n = 31) or laparoscopic supracervical hysterectomy (n = 31). MAIN OUTCOME MEASURES: The primary outcome measure, measured 12 months after intervention, was reduction of cyclic pelvic pain (visual analogue scale, 0-10). Secondary outcome measures included patient satisfaction (visual analogue scale, 0-10) and quality of life (Short Form 36, 0-100). RESULTS: The groups were comparable at baseline. There was no difference in self-reported dysmenorrhoea at 12 months (mean 0.8 [SD 1.6] versus 0.8 [SD 2.0], P = 0.94). There was no difference in patient satisfaction (mean 9.3 [SD 1.5] versus 9.1 [SD 1.2], P = 0.66) or quality of life (mean 81.6 [SD 17.8] versus 80.2 [SD 18.0], P = 0.69). CONCLUSION: Improvement in dysmenorrhoea and quality of life as well as patient satisfaction were comparable in the medium term when comparing total laparoscopic hysterectomy with laparoscopic supracervical hysterectomy.

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.

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.

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.

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.