Feeling of pulsations in artificial arteries with a real time haptic feedback laparoscopic grasper: a validation study.

INTRODUCTION: Despite the advancements in technology and organized training for surgeons in laparoscopic surgery, the persistent challenge of not being able to feel the resistance and characteristics of the tissue, including pulsations, remains unmet. A recently developed grasper (Optigrip®) with real time haptic feedback, based on photonic technology, aims to address this issue by restoring the tactile sensation for surgeons. The key question is whether pulsations can be detected and at what minimal size level they become clinical significant. METHODS: To simulate arterial conditions during laparoscopic procedures, four different silicone tubes were created, representing the most prevalent arteries. These tubes were connected to a validated pressure system, generating a natural pulse ranging between 80 and 120 mm Hg. One control tube without pressure was added. The surgeons had to grasp these tubes blindly with the conventional grasper or the haptic feedback grasper in a randomized order. They then indicated whether they felt the pressure or not and the percentage of correct answers was calculated. RESULTS: The haptic grasper successfully detected 96% of all pulsations, while the conventional grasper could only detect 6%. When considering the size of the arteries, the Optigrip® identified pulsations in 100% the 4 and 5 mm arteries and 92% of the smallest arteries. The conventional grasper was only able to feel the smallest arteries in 8%. These differences were highly significant (p < 0.0001). CONCLUSION: This study demonstrated that the newly developed haptic feedback grasper enables detection of arterial pulsations during laparoscopy, filling an important absence in tactile perception within laparoscopic surgery.

Male or female sterilization - the decision making process: Counselling and regret.

OBJECTIVE(S): To analyze the decision-making process of both male and female sterilization in order to improve counselling and prevent regret after sterilization in the future. STUDY DESIGN: An online questionnaire regarding sterilization (counselling, sources of information and regret) was promoted on Facebook, Twitter and LinkedIn. A total of 1107 men and women who had undergone or considered sterilization in the Netherlands filled in the questionnaire. RESULTS: A total of 88.9 % of the sterilized group and 67.4 % in the considered group responded that they felt well informed when they considered sterilization. However, less than half of the participants in both groups knew about all different sterilization methods. In both groups participants reported they consulted their partner the most when they considered sterilization. After sterilization 7.7 % reported having regret. Regret was reported more often when participants were sterilized ≤ 30 years. Most important reasons for regret reported by males were complications, pain, a new wish to conceive and divorce/remarriage. Most important reasons for regret reported by females were pain, complications, a new wish to conceive and menstrual symptoms. A total of 21.1 % in the sterilized and 38.0 % in the considered group responded they would have liked to use a decision aid when they considered sterilization. CONCLUSIONS: Findings of this study provide insight in the decision-making process regarding sterilization. There is a lack of knowledge of different methods of sterilization and 7.7% regrets their sterilization afterwards. Furthermore, the results show an importance of developing a decision aid for couples considering sterilization.

Potential Value of Haptic Feedback in Minimally Invasive Surgery for Deep Endometriosis.

Introduction. Laparoscopic treatment of deep endometriosis (DE) is associated with intra- and post-operative morbidity. New technological developments, such as haptic feedback in laparoscopic instruments, could reduce the rate of complications. The aim of this study was to assess the room for improvement and potential cost-effectiveness of haptic feedback instruments in laparoscopic surgery. Methods. To assess the potential value of haptic feedback, a decision analytical model was constructed. Complications that could be related to the absence of haptic feedback were included in the model. Costs of complications were based on the additional length of hospital stay, operating time, outpatient visits, reinterventions, and/or conversions to laparotomy. The target population consists of women who are treated for DE in the Netherlands. A headroom analysis was performed to estimate the maximum value of haptic feedback in case it would be able to prevent all selected intra- and post-operative complications. Results. A total of 9.7 intraoperative and 47.0 post-operative complications are expected in the cohort of 636 patients annually treated for DE in the Netherlands. Together, these complications cause an additional length of hospital stay of 432.1 days, 10.2 additional outpatient visits, 73.9 reinterventions, and 4.2 conversions. Most consequences are related to post-operative complications. The total additional annual costs due to complications were €436 623, amounting to €687 additional costs per patient. Discussion. This study demonstrated that the potential value for improvement in DE laparoscopic surgery by using haptic feedback instruments is considerable, mostly caused by the potential prevention of major post-operative complications.

Long-term follow-up after successful Essure sterilization: evaluation of patient satisfaction, symptoms, and the influence of negative publicity.

OBJECTIVE: To evaluate long-term patient satisfaction and symptoms after successful Essure sterilization and the influence of negative publicity on patients' opinion. DESIGN: Survey study. SETTING: Two nonacademic hospitals. PATIENT(S): All 924 women who underwent successful Essure sterilization between 2003 and 2009. INTERVENTION(S): A questionnaire was sent between 2008 and 2010 and in 2018. MAIN OUTCOME MEASURE(S): Patient satisfaction, symptoms, and the influence of negative publicity on patients' opinion of Essure sterilization. RESULT(S): After a median follow-up of 29 months, 689 of 924 women (74.6%) responded to the first questionnaire. Of these women, 673 of 689 (97.7%) was satisfied with their Essure sterilization and 607 of 689 (88.1%) recommended Essure sterilization to other women. Of the 689 women, 71 (10.3%) reported having symptoms after Essure sterilization for which they had to consult a physician. Most reported symptoms were menstrual and abdominal pain. After a median follow-up of 144 months, 317 of 577 women (54.9%) responded to the second questionnaire. A total of 157 of 317 (49.5%) women reported having symptoms and in 51 (16.1%) women the Essure devices were surgically removed. Among these women, 29 (57%) reported that their symptoms disappeared afterward and 33 of 51 (65%) women reported that negative publicity had somehow affected their decision to undergo surgery. CONCLUSION(S): After a follow-up of 144 months, approximately 50% of the women reported having symptoms and 16% underwent Essure removal surgery. Publicity had a negative influence on patients' opinion of Essure sterilization, as well as an effect on the decision-making process regarding Essure removal. These data are important when facing women with possible Essure-related complaints.

Performance of a Haptic Feedback Grasper in Laparoscopic Surgery: A Randomized Pilot Comparison With Conventional Graspers in a Porcine Model.

Background. Compared with open surgery, minimally invasive surgery is limited by reduced sensation of tissue properties. A laparoscopic grasper with integrated haptic feedback technology that improves the ability to sense tissue properties might provide a solution. The force reflecting operation instrument (FROI) is a new laparoscopic grasper, designed to provide information about the interaction forces between the instrument and tissue through resistance in the handle. This pilot study aimed to assess the functionality of the FROI compared with a conventional grasper in an in vivo setting. Methods. In this randomized trial, we used a standard laparoscopic surgical setup to perform laparoscopic surgery in pigs. In all, 11 surgeons performed colorectal, gynecological, or urological procedures, once with the FROI and once with a conventional grasper. Participants were asked to complete the NASA Task Load Index Rating Scale and rate 5 specific features for both graspers. To capture opinions on the overall functionality of the FROI, participants were asked to answer 8 open questions. Results. The surgeons reported that the use of the FROI significantly improved tissue consistency perception, arterial pulse detection, and force control compared with the conventional grasper. No significant differences were found in surgeons' muscular strain or operative time. The most emphasized topics in the open questions were improved soft-tissue handling and importance for complex procedures. Conclusion. Through this first in vivo analysis of the functionality of the FROI, a multispecialty group of laparoscopic surgeons confirmed the added value of haptic feedback technology in a live surgical setting.

Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement.

STUDY OBJECTIVE: To evaluate the algorithm of transvaginal ultrasound (TVU) and/or modified hysterosalpingogram (HSG) confirmation testing 3 months after Essure placement to determine if women can rely on the device for permanent birth control. DESIGN: Interim analysis of an ongoing 10-year, prospective, multicenter, nonrandomized, single-arm, international trial (Canadian Task Force classification II-2). SETTING: Twenty study centers in the United States (n = 12), Canada (n = 1), The Netherlands (n = 6), and Spain (n = 1). PATIENTS: Women undergoing the Essure procedure for permanent birth control. INTERVENTIONS: Based on the algorithm for confirmation testing, women with an uncomplicated Essure procedure underwent TVU as the confirmation test; modified HSG was used for women ineligible for TVU, when TVU findings were abnormal or inconclusive, or based on the physician's discretion. MEASUREMENTS AND MAIN RESULTS: Co-primary endpoints (intention-to-treat [ITT] population) were the reliance rate and the 1-year pregnancy rate. Safety evaluation was based on adverse events. Bilateral insert placement was attempted in 597 women (ITT population) and achieved in 582 of 597 (97.5%). A total of 547 women were told to rely on Essure for permanent birth control. Both co-primary endpoints met prespecified limits: based on Bayesian statistics, the reliance rate was 91.6% (547/597; 95% credible interval, 89.2%-93.6%) and the 1-year pregnancy rate .67% (95% credible interval, .16%-1.53%). Using the algorithm for confirmation testing, of 547 subjects told to rely on Essure, 470 (86%) underwent TVU alone, 30 (6%) had modified HSG alone, and 47 (9%) had TVU followed by modified HSG. Four women became pregnant after being told to rely on Essure. They all had confirmation testing with TVU alone, and each initially read incorrectly as optimal insert locations. In each case postpregnancy follow-up and root cause analysis revealed unsatisfactory insert locations, 2 of which were perforations. Most adverse events were mild and unrelated to Essure. CONCLUSION: The algorithm of TVU and/or modified HSG confirmation testing 3 months after Essure placement can determine that a woman can rely on the device for permanent birth control. The adverse events observed are consistent with the known safety profile of Essure. (clinicaltrials.gov: NCT01327105.).

The effects of laparoscopic graspers with enhanced haptic feedback on applied forces: a randomized comparison with conventional graspers.

BACKGROUND: Haptic feedback, which enables surgeons to perceive information on interaction forces between instrument and tissue, is deficient in laparoscopic surgery. This information, however, is essential for accurate tissue manipulation and recognition of tissue consistencies. To this end, a laparoscopic grasper with enhanced haptic feedback has been developed: the force reflecting operation instrument (FROI). This study tested the effects of enhanced haptic feedback on force control, tissue consistency interpretation, and the associated surgeons' level of confidence through a randomized controlled crossover experiment. METHODS: A randomized three-period crossover trial was conducted, in which seven surgical residents and 13 medical students participated. The setup involved a box trainer in which slices of porcine organs (lung, small intestine, or liver) were presented. Participants performed three series of blinded palpation tasks involving three different graspers: the conventional grasper, the FROI with enhanced haptic feedback activated, and the FROI with enhanced haptic feedback deactivated. In each series, nine pairs of organ tissues were palpated to compare consistencies. The orders of presenting both instruments and tissues were randomized. RESULTS: The force applied during tissue palpation significantly decreased, by a mean factor of 3.1 with enhanced haptic feedback. Tissue consistency interpretation was significantly improved with more correct assessments and participants answered with significantly more confidence when enhanced haptic feedback was available. CONCLUSION: The availability of enhanced haptic feedback enabled participants to operate with significantly reduced interaction force between instrument and tissues. This observation is expected to have multiple important clinical implications, such as less tissue damage, fewer complications, shorter operation times, and improved ergonomics.

Evaluation of Nickel Allergic Reactions to the Essure Micro Insert: Theoretical Risk or Daily Practice?

STUDY OBJECTIVE: To evaluate whether de novo development of nickel sensitization is related to placement of the Essure device, and to evaluate whether the grade of reaction to nickel increased after device placement in patients with a confirmed nickel allergy. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Two nonacademic training hospitals in The Netherlands. PATIENTS: Healthy women of childbearing age desiring permanent sterilization. INTERVENTIONS: At least 72 hours before Essure sterilization, each patient received 2 patches, 1 patch with a nickel solution in 5% petrolatum and 1 control patch. In addition, the patient was asked to complete a questionnaire on allergy-related symptoms. The patch test was scored according to the criteria for contact dermatitis of Devos and Van Der Valk. At 3 months after Essure sterilization, the patch test and the questionnaire were repeated. MEASUREMENTS AND MAIN RESULTS: All 169 patients underwent Essure sterilization and completed the patch test cycle. There were no statistically significant changes in patch test results and allergy-related symptoms after sterilization. Before sterilization, 29% of the patients had a positive patch test and 1.8% also showed a positive reaction to the control patch. Only 20.7% of the patients had a history of allergic reactions to nickel. After sterilization, 29% had a positive patch test and 0.6% also showed a positive reaction to the control patch. Among the patients with a positive patch test before sterilization, the grade of reaction did not increase after sterilization. Moreover, these patients did not exhibit any increase in allergy-related symptoms. Among 4 patients with a previous negative patch test, 2 developed a grade 1 reaction and 2 developed a grade 2 reaction after sterilization. Two of these 4 patients had a history of allergic reactions to nickel before sterilization despite a negative patch test. After sterilization, these 4 patients exhibited no increase in allergy-related symptoms. CONCLUSION: There were no statistically significant changes in nickel patch test results and allergy-related symptoms after Essure sterilization. Furthermore, among the patients with a positive patch test before Essure sterilization, the grade of reaction did not increase after sterilization. These results indicate that Essure sterilization likely is not related to nickel sensitization.

Ergonomics of laparoscopic graspers and the importance of haptic feedback: the surgeons' perspective.

Haptic feedback is drastically reduced in laparoscopic surgery compared to open surgery. Introducing enhanced haptic feedback in laparoscopic instruments might well improve surgical safety and efficiency. In the design process of a laparoscopic grasper with enhanced haptic feedback, handle design should be addressed to strive for optimal usability and comfort. Additionally, the surgeons' perspective on the potential benefits of haptic feedback should be assessed to ascertain the clinical interest of enhanced haptic feedback. A questionnaire was designed to determine surgeons' use and preferences for laparoscopic instruments and expectations about enhanced haptic feedback. Surgeons were also asked whether they experience physical complaints related to laparoscopic instruments. The questionnaire was distributed to a group of laparoscopic surgeons based in Europe. From the 279 contacted subjects, 98 completed the questionnaire (response rate 35 %). Of all respondents, 77 % reported physical complaints directly attributable to the use of laparoscopic instruments. No evident similarity in the main preference for graspers was found, either with or without haptic feedback. According to respondents, the added value of haptic feedback could be of particular use in feeling differences in tissue consistencies, feeling the applied pressure, locating a tumor or enlarged lymph node, feeling arterial pulse, and limiting strain in the surgeon's hand. This study stresses that the high prevalence of physical complaints directly related to laparoscopic instruments among laparoscopic surgeons is still relevant. Furthermore, the potential benefits of enhanced haptic feedback in laparoscopic surgery are recognized by laparoscopic specialists. Therefore, haptic feedback is considered an unmet need in laparoscopy.

Twelve-year retrospective review of unintended pregnancies after Essure sterilization in the Netherlands.

OBJECTIVE: To identify factors contributing to the occurrence of unintended pregnancies after Essure sterilization in the Netherlands. Even though Essure is a permanent method of contraception, unintended pregnancies have been reported. DESIGN: Retrospective case series analysis. SETTING: Not applicable. PATIENT(S): Thirty-five pregnancies were reported in the Netherlands after Essure sterilization from 2002 through 2014 out of 27,346 placements. INTERVENTION(S): Data regarding Essure placement procedure, confirmation tests, and pregnancy outcome of the reported cases were obtained and analyzed to identify a possible cause of failure. MAIN OUTCOME MEASURE(S): Four causes of failure were identified: perforation (n = 10), expulsion (n = 7), unilateral placement (n = 7), and luteal pregnancy (n = 2). RESULT(S): The occurrence of most pregnancies was related to physician noncompliance (n = 14). The other cases were associated with patient noncompliance (n = 5) or misinterpretation of the confirmation test (n = 9). Most pregnancies occurred within the first 24 months after the 3-month confirmation test (n = 23). CONCLUSION(S): The results of this study show that the incidence of pregnancies after Essure sterilization is low. Most pregnancies were related to incorrect positioning of a device or unilateral placement, and seem therefore preventable. Unilateral placement without prior history of salpingectomy should always be considered as unsuccessful sterilization. Furthermore, interpretation of the confirmation tests should be done by trained physicians, and with caution. We want to emphasize the importance of strictly adhering to placement and follow-up protocols.

Confirmation of Essure placement using transvaginal ultrasound.

STUDY OBJECTIVE: To evaluate the protocol for confirmation of satisfactory Essure placement using transvaginal ultrasound. DESIGN: Prospective multicenter cohort study (Canadian Task Force classification II-2). SETTING: Outpatient departments of 4 teaching hospitals in the Netherlands. PATIENTS: Eleven hundred forty-five women who underwent hysteroscopic sterilization using the Essure device between March 2005 and December 2007. INTERVENTION: Transvaginal ultrasound examination 12 weeks after uncomplicated successful bilateral placement or as indicated according to the transvaginal ultrasound protocol after 4 weeks, and hysterosalpingography (HSG) at 12 weeks to confirm correct placement of the device after 3 months. MEASUREMENTS AND MAIN RESULTS: The rate of successful placement was 88.4% initially. In 164 women (15%), successful placement was confirmed at HSG according the protocol. In 9 patients (0.84%), incorrect position of the device was observed at HSG. The cumulative pregnancy rate after 18 months was 3.85 per thousand women. CONCLUSION: Transvaginal ultrasound should be the first diagnostic test used to confirm the adequacy of hysteroscopic Essure sterilization because it is minimally invasive, averts ionizing radiation, and does not decrease the effectiveness of the Essure procedure.

Unintended pregnancies after Essure sterilization in the Netherlands.

OBJECTIVE: To analyze the data of cases of unintended pregnancies after Essure sterilization. DESIGN: Retrospective case series analysis. SETTING: National multicenter. PATIENT(S): Ten cases of unintended pregnancies after Essure sterilization in the Netherlands were reported from August 2002 through May 2008. INTERVENTION(S): Data on the hysteroscopic Essure sterilization procedures and postprocedure confirmation tests of the reported cases were reviewed and analyzed by two authors. The causes of the unintended pregnancies were determined in agreement with the physicians who performed the sterilizations. MAIN OUTCOME MEASURE(S): Most pregnancies occurred in patients with only one device placement and bilateral occlusion on hysterosalpingography (HSG). Other cases included misinterpretation of HSG, undetected abnormal device position by ultrasound, one undetected preprocedure pregnancy, and two patient failures to follow up with the physician advice. CONCLUSION(S): The risk of pregnancy after hysteroscopic sterilization may be reduced by strictly following the follow-up protocol, performing a urinary pregnancy test on the day of the procedure, and instructing the patient to return for the follow-up visit. A procedure with only a single device placement in a patient without a history of tubectomy of the heterolateral tube should be considered unsuccessful.

Bilateral cornual abscess after endometrial ablation following Essure sterilization.

Endometrial ablation is used extensively to treat dysfunctional bleeding. Since the introduction of Essure tubal sterilization, this permanent contraception method has been widely used. Both endometrial ablation and Essure sterilization are procedures reported to have only a few complications. We describe a serious infectious complication shortly after an endometrial ablation in a patient with Essure microinserts in situ. To our knowledge, this complication has not been reported before in patients with Essure microinserts in situ. We suggest administering prophylactic antibiotics before endometrial ablation in women with Essure microinserts in situ.

Follow-up of successful bilateral placement of Essure microinserts with ultrasound.

OBJECTIVE: To evaluate the reliability of pelvic X-ray and transvaginal ultrasound to localize Essure microinserts (Conceptus, San Carlos, California) after successful placement in both fallopian tubes 3 months after placement. DESIGN: Prospective, observational study. SETTING: Gynecology departments at two teaching hospitals. PATIENT(S): One hundred eighty-two patients who underwent hysteroscopic sterilization by placement of Essure microinserts between August 2002 and August 2004. INTERVENTION(S): Transvaginal ultrasound, pelvic X-ray, and hysterosalpingography (HSG) 3 months after sterilization with Essure. MAIN OUTCOME MEASURE(S): Transvaginal ultrasound confirmation of correct localization of microinserts after a 3-month follow-up. RESULT(S): In 150 of 182 patients, confirmation of successful bilateral placement of two microinserts (300 devices) was possible. In 9 patients it was not possible to identify both devices with ultrasound, or there was doubt about the extension of the device through the uterotubal junction. The other 291 devices were identified as being in a good position. CONCLUSION(S): Hysterosalpingography at the 3-month follow-up after successful placement of Essure microinserts can be replaced by transvaginal ultrasonography. A 3-month follow-up with HSG after the Essure procedure is only required after unsatisfactory placements. In those patients in whom transvaginal ultrasonography cannot confirm satisfactory localization, a complementary pelvic X-ray should be performed.

Efficacy and satisfaction rate comparing endometrial ablation by rollerball electrocoagulation to uterine balloon thermal ablation in a randomised controlled trial.

OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal ablation (Thermachoice trade mark ), regarding efficacy for reducing dysfunctional uterine bleeding and patients satisfaction rate. METHODS: A randomised controlled study was performed in a teaching hospital at the department of gynaecology. One hundred and thirty-seven premenopausal women with dysfunctional uterine bleeding proved by validated menstrual score list were included. Endometrial ablation by a hysteroscopic or non-hysteroscopic method was performed by one gynaecologist. RESULTS: Reduction of menstrual blood loss was significantly more successful at 24 months for thermal ablation with uterine balloon. Success rate measured by menstrual score < 185 for rollerball and thermal balloon ablation are equivalent at 12 and 24 months post-operatively. Satisfaction of the patients for both methods at 24 months post-operatively is not significantly different (respective 75% for rollerball and 80% for uterine balloon). CONCLUSIONS: Endometrial ablation by uterine balloon thermal ablation (Thermachoice trade mark ) is equally effective as hysteroscopic RBE of the endometrium.

Endometrial ablation by rollerball electrocoagulation compared to uterine balloon thermal ablation. Technical and safety aspects.

OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal (UBT) ablation (Thermachoice), regarding intra- and post-operative technical complications and safety aspects. STUDY DESIGN: A randomised controlled study in a teaching hospital, 139 pre-menopausal women with dysfunctional uterine bleeding proved by a validated menstrual score list were enclosed. Endometrial ablation by a hysteroscopic or non-hysteroscopic method was performed. RESULTS: Rollerball electrocoagulation carries a significantly higher risk of intra-operative complications compared to uterine balloon thermal ablation and is a significantly more time consuming procedure. Post-operative complication rates in both groups were low, but post-operative analgesics were prescribed significantly more in the uterine balloon group. CONCLUSION: Endometrial ablation by uterine balloon thermal ablation (Thermachoice) is a safe and simple non-hysteroscopic procedure.

Diagnostic hysteroscopy: a valuable diagnostic tool in the diagnosis of structural intra-cavital pathology and endometrial hyperplasia or carcinoma?. Six years of experience with non-clinical diagnostic hysteroscopy.

OBJECTIVE: 1045 diagnostic hysteroscopic procedures performed throughout six consecutive years were evaluated, focussing on its value in diagnosing endometrial hyperplasia and carcinoma. DESIGN: Retrospective study performed in the gynaecological endoscopy clinic of a training hospital. Subjects were 1045 pre- and post-menopausal patients. RESULTS: A normal cavity was found in 54.2%. Most common abnormal findings were fibroids (21.0%) and endometrial polyps (14.4%). Hysteroscopically diagnosed hyperplasia of the endometrium was confirmed histologically in only less than half the cases. Endometrial carcinoma was suspected on hysteroscopic view in two cases of a total of seven proven cases. In three cases initially an endometrial polyp and in two cases a fibroid was diagnosed. Once the diagnosis was missed even after biopsy taking. CONCLUSIONS: Diagnostic hysteroscopy is a valuable diagnostic tool in diagnosing structural intra-cavital pathology, very suitable for the outpatient clinic. The value in diagnosing hyperplasia or endometrial carcinoma is limited and even after guided biopsy a malignancy cannot be ruled out.