Theodoor E. Nieboer

Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial.

OBJECTIVE: To report the 4-year follow-up quality-of-life data of a randomized controlled trial between abdominal and laparoscopic hysterectomy and to investigate whether any difference in quality of life would remain long-term. METHODS: Patients scheduled for hysterectomy for benign indications were randomized and received the Dutch version of the Short Form 36 questionnaire. The Short Form 36 consists of eight domains in which 100 points can be obtained. Higher scores denote a higher quality of life. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery for each of the domains and the total Short Form 36 score separately. RESULTS: Fifty-nine patients were randomized (27 to laparoscopic hysterectomy and 32 to abdominal hysterectomy). Median follow-up after surgery was 243 weeks (range, 188–303 weeks). The overall response rate on the Short Form 36 questionnaire after 4 years was 83% (49 of 59 patients). Total Short Form 36 questionnaire scores were significantly higher in patients after laparoscopic compared with abdominal hysterectomy up to 4 years after surgery (overall mean difference 50.4 points [95% confidence interval 1.0–99.7] in favor of laparoscopic hysterectomy). Higher scores were also found on the domains physical role functioning, social role functioning, and vitality. CONCLUSION: With a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported a better quality of life compared with abdominal hysterectomy. Therefore, patients in whom vaginal hysterectomy is not possible should be able to have a laparoscopic hysterectomy, if feasible, in terms of uterine size. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN15214439. LEVEL OF EVIDENCE: I

The effect of vulvar lichen sclerosus on quality of life and sexual functioning

Lichen sclerosus (LS) is a chronic skin disorder mostly seen on the female anogenital skin. The aim of this study was to evaluate the quality of life (QoL) and sexuality in female patients with LS and to compare their scores with healthy controls. In addition, we wanted to find factors associated with impaired sexual functioning in patients with LS.  Members of the Dutch LS foundation and support group were asked to fill in three questionnaires: the Dermatology Quality of Life Index, Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS). 215 of 368 patients returned their questionnaire (58.4%). Their scores were compared to a control group which consisted of 61 women of similar age (p = 0.472) without a skin disorder.  Of all domains of QoL, LS interfered most with sexual functioning. Patients significantly scored lower on all subscales of the FSFI (desire (p = 0.016), arousal (p < 0.001), lubrication (p < 0.001), orgasm (p < 0.001), satisfaction (p < 0.001) and pain (p < 0.001), indicating worse sexual functioning. These problems with sexual functioning brought about significant sexual distress (p < 0.001). Patients who experienced more influence on their QoL had more sexual difficulties, leading to more sexual distress independent of their age.

Women in the Netherlands prefer self-sampling with a novel lavaging device to clinician collection of specimens for cervical cancer screening.

Recent evidence suggests that screening for high-risk human papillomavirus (HPV) is more sensitive than using the standard Papanicolaou (Pap) test for identifying women with high grade cervical lesions, as precursors to cervical cancer.1 Furthermore, studies have shown that specimens collected by women themselves are equivalent to clinician-collected specimens for the detection of high-risk HPV using nucleic acid amplification tests.2–4 The use of self-collected specimens enables cervical cancer screening to occur in home and community settings, which could expand program coverage, facilitate outreach, streamline clinic processes, and remove barriers to care. Low uptake of cervical cancer screening in some groups of women suggests imperfect acceptability of the standard Pap.5 We need to expand ways for women to be screened for cervical cancer, including using validated self-sampling techniques. In the Netherlands, a national governmental program for cervical cancer screening has been implemented since 1988. The program currently invites all women from a centralized registry between the ages of 30 and 60 by mail to appointments with a general practitioner for a Pap smear. Women with normal cytology are followed every 5 years. Despite organized outreach, over 30% of women do not respond to screening invitations, with fear of the Pap smear and shame commonly cited as reasons for nonattendance.6 Furthermore, approximately 50% of cervical cancers is identified in women who did not respond to screening invitations.7 Use of validated self-sampling techniques combined with HPV testing could improve program coverage for these women, at a cost comparable to that of a Pap smear. We therefore investigated the acceptability of using a selflavaging device (Pantarhei Devices, Zeist, The Netherlands) compared with the standard pelvic exam among 91 women in the Netherlands. The validity of the specimens in combination with the GP 5 /6 polymerase chain reaction test for detection of highrisk HPV has been previously described.8 In this paper, we describe women’s responses to using the device. From February to October 2004, 106 women were invited from 3 obstetric and gynecology hospital departments in Veldhoven, Arnhem, and Tilburg, in the Netherlands, of which 104 agreed to participate. Seventy women scheduled for colposcopy due to a recent abnormal Pap smear were recruited by phone and/or mail before their colposcopy appointment; 34 women attending the outpatient clinic for reasons not related to cervical abnormalities and who were due for a Pap smear were recruited in person at the clinic. To be eligible women had to be proficient in Dutch, not pregnant or currently lactating, and without a mental or physical handicap that would prevent self-collection of specimens. Participating women were mailed an informed consent form, the self-sampling device for collection of specimens, instructions on how to use the device with diagrams, and a short self-administered acceptability questionnaire with open-ended questions. They were asked to collect a specimen at home using the Pantarhei Screener 1 week before their scheduled pelvic exam. Women brought the informed consent, specimen and questionnaire to their clinic appointment, and completed a second acceptability questionnaire The authors thank Prof. Chris Meijer of the VU University Medical Center and Dr. and Prof. Herjan Coelingh Bennink for their scientific oversight and technical expertise on this project. The authors also thank the women for participating, and Marloes Voll, Rene Hol, and Stella Beenhackker for their editorial review of the paper. Supported by Pantarhei Devices, the maker of the device. Maarten AHM Wiegerick is one of the original inventors of the device and a shareholder of Pantarhei Devices, and as such has a financial interest in the product. Correspondence: Heidi Jones, Division of Family Planning & Preventive Services, Department of Obstetrics & Gynecology, Columbia University Medical Center, 622 W. 168th St. PH 16-69, New York, NY 10032. E-mail: hej2103@columbia.edu. Received for publication December 17, 2007 and accepted May 26, 2008. From the *Division of Family Planning and Preventive Services, Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, USA. †Máxima Medical Center, Veldhoven, the Netherlands; and ‡Rijnstate Hospital, Arnhem, the Netherlands Sexually Transmitted Diseases, November 2008, Vol. 35, No. 11, p.916–917 DOI: 10.1097/OLQ.0b013e3181812cf0 Copyright

First case of juvenile granulosa cell tumor in an adult with Ollier disease.

Olliers disease (OD) is a rare disorder associated with the presence of multiple enchondromas. Granulosa cell tumors are rare sex cord-stromal ovarian tumors. This is the first report of a patient in her fourth decade with a combination of OD and juvenile granulosa cell tumor.A 36-year-old woman with OD developed an ovarian tumor. The tumor was found at a routine MRI scan. During surgery a stage IIc granulosa cell tumor was removed; pathologic examination showed a juvenile type. A review of literature showed 8 previous cases of (juvenile) granulosa cell tumor associated with OD.The coexistence of granulosa cell tumors in patients with OD is more frequent than expected by chance. We suggest that patients with OD should undergo regular gynecological investigation.

A randomized trial of training the non-dominant upper extremity to enhance laparoscopic performance

Abstract Introduction: In laparoscopy, the surgeons dominant arm will execute difficult tasks with less effort compared to the non-dominant arm. This leads to a relative overuse of muscles on this side. We hypothesized that training the non-dominant arm would improve laparoscopic skills. Material and methods: At baseline, all participants performed three validated tasks on a virtual reality simulator. After randomization, subjects in the intervention group were assigned training tasks. All these tasks had to be performed with the non-dominant hand. Within a week after a three-week study period, participants performed the same three tasks as before. Results: Twenty-six participants were included, 13 in each group. At baseline, there were no differences between groups on all tested parameters. Compliance to training tasks was good. At the end of three weeks, subjects in both groups showed similar improvement of skills on the non-dominant side. On the dominant side, however, subjects in the training group showed significant better improvement of skills on four out of eight parameters. Conclusion: Specific training of the non-dominant upper extremity appears to lead to improvement of skills on the dominant side, a phenomenon known in literature as intermanual transfer of skill learning. To improve laparoscopic skills, bimanual training is recommended.

The Physical Workload of Surgeons: A Comparison of SILS and Conventional Laparoscopy

Background. As extensively reported in the literature, laparoscopic surgery has many advantages for the patient. Surgeons, however, experience increased physical burden when laparoscopic surgery is compared with open surgery. Single-incision laparoscopic surgery (SILS) has been said to further enhance the patient’s benefits of endoscopic surgery. Because in this surgical technique only 1 incision is made instead of the 3 to 5, as in conventional laparoscopic surgery (CLS), it is claimed to further reduce discomfort and pain in patients. Yet little is known about its impact on surgeons. This study aims to contribute by indicating the possible differences in physical workload between single-incision laparoscopy and CLS. Methods. A laparoscopic box trainer was used to simulate a surgical setting. Participants performed 2 series of 3 different tasks in the box: one in the conventional way, the other through SILS. Surface electromyography was recorded from 8 muscles bilaterally. Furthermore, questionnaires on perceived workload were completed. Results. Differences were found in the back, neck, and shoulder muscles, with significantly higher muscle activity in the musculus (M) longissimus, M trapezius pars descendens, and the M deltoideus pars clavicularis. Questionnaires did not indicate any significant differences in perceived workload. Conclusion. Performing SILS versus CLS increases the objectively measured physical workload of surgeons particularly in the back, neck, and shoulder muscles.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial

BackgroundMedical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.Methods/DesignThe proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients’ quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.DiscussionThis trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Trial registrationDutch Trial Register: NTR3110

Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial

In Reply: We appreciate the opportunity to respond to the comments and concerns raised by Drs. Goldstuck and Wildemeersch. Data from our study show that, although nulliparous women were significantly more likely to report pain with intrauterine device (IUD) use as compared with parous women (34% compared with 28%, P5.02), their discontinuation rates were similar. Expulsion rates were identical in both groups, as was the rate of abnormal bleeding. The overall uterine perforation rate was 0.3%; all three cases occurred in parous women. In regard to uterine dimensions and the effect of age, Benacerraf found no appreciable relationship between patient age and the width of the uterine cavity in patients who were never pregnant. However, the width of the cavity enlarged significantly with increasing parity (27.2 mm in nulliparous women, 29.6 mm with one pregnancy, and 31.1 mm with more than one pregnancy). Nevertheless, based on these data, even women with one previous pregnancy had a mean width narrower than the width of the Mirena and Paragard IUDs (less than 32 mm). This study had a small sample size, and the uterine cavities were measured regardless of the menstrual cycle, which may have affected the results. It is indeed a concern that women with narrow uterine cavities might be at increased risk of side effects with IUD use. Further studies are needed to determine whether measurement of the width of the uterine cavity should be performed before IUD insertion. In addition, the new IUD Skyla, with its smaller dimensions, may lessen these side effects, but that remains to be proven. Until more research becomes available, the Mirena and Paragard IUDs should continue to be offered to adolescents and nulliparous women because their benefits outweigh the medical risks and social consequences associated with teenage pregnancies, abortions, and undesired pregnancies. We did not specifically study the effects of counseling on IUD discontinuation rates. However, Garbers et al found that early discontinuation of the copper-containing IUD was lower among women who received method-specific health education before IUD insertion. These data suggest that delivering health education that addresses issues specific to IUD use may reduce early discontinuation.

Does Training of the Nondominant Upper Extremity Reduce the Surgeon's Muscular Strain During Laparoscopy? Results From a Randomized Controlled Trial

Introduction. In laparoscopy, suboptimal ergonomics frequently lead to morbidity for surgeons. Physical complaints are more commonly reported on the dominant upper extremity. This may be the consequence of challenging laparoscopic tasks being easier to perform with the dominant side. The authors hypothesized that specific training of the nondominant upper extremity may equip this side better and lead to a more equal distribution of physical load. Materials and methods. Participants (medical doctors) were randomized to a 3-week training schedule or no training. The training program consisted of training the nondominant upper extremity. Participants were not allowed to train on a laparoscopic box or virtual reality trainer during the study period. Baseline and outcome measurements after 3 weeks were examined with the use of EMG measurements during a validated task on a laparoscopic box trainer. Muscle strain of the trapezius and deltoid muscles and effective alternation of brachioradial and abductor pollicis brevis muscles were used as outcome variables. Results. In all, 26 participants were included. EMG analysis revealed that participants in both intervention and control groups showed a decrease in muscle strain of trapezius and deltoid muscles. However, there were no significant differences between groups. Those in the intervention group showed significantly better alternation in the brachioradial muscle. Conclusion. Training the nondominant upper extremity leads to better alternated use of lower-arm muscles during a validated box trainer task. Repeating the task after 3 weeks led to less muscle tension in the trapezius and deltoid muscles.

The Effect of Screen-to-Screen Versus Face-to-Face Consultation on Doctor-Patient Communication: An Experimental Study with Simulated Patients

Background Despite the emergence of Web-based patient-provider contact, it is still unclear how the quality of Web-based doctor-patient interactions differs from face-to-face interactions. Objective This study aimed to examine (1) the impact of a consultation medium on doctors’ and patients’ communicative behavior in terms of information exchange, interpersonal relationship building, and shared decision making and (2) the mediating role of doctors’ and patients’ communicative behavior on satisfaction with both types of consultation medium. Methods Doctor-patient consultations on pelvic organ prolapse were simulated, both in a face-to-face and in a screen-to-screen (video) setting. Twelve medical interns and 6 simulated patients prepared 4 different written scenarios and were randomized to perform a total of 48 consultations. Effects of the consultations were measured by questionnaires that participants filled out directly after the consultation. Results With respect to patient-related outcomes, satisfaction, perceived information exchange, interpersonal relationship building, and perceived shared decision making showed no significant differences between face-to-face and screen-to-screen consultations. Patients’ attitude toward Web-based communication (b=−.249, P=.02 and patients’ perceived time and attention (b=.271, P=.03) significantly predicted patients’ perceived interpersonal relationship building. Patients’ perceived shared decision making was positively related to their satisfaction with the consultation (b=.254, P=.005). Overall, patients experienced significantly greater shared decision making with a female doctor (mean 4.21, SD 0.49) than with a male doctor (mean 3.66 [SD 0.73]; b=.401, P=.009). Doctor-related outcomes showed no significant differences in satisfaction, perceived information exchange, interpersonal relationship building, and perceived shared decision making between the conditions. There was a positive relationship between perceived information exchange and doctors’ satisfaction with the consultation (b=.533, P<.001). Furthermore, doctors’ perceived interpersonal relationship building was positively related to doctors’ satisfaction with the consultation (b=.331, P=.003). Conclusions In this study, the quality of doctor-patient communication, as indicated by information exchange, interpersonal relationship building, and shared decision making, did not differ significantly between Web-based and face-to-face consultations. Doctors and simulated patients were equally satisfied with both types of consultation medium, and no differences were found in the manner in which participants perceived communicative behavior during these consultations. The findings suggest that worries about a negative impact of Web-based video consultation on the quality of patient-provider consultations seem unwarranted as they offer the same interaction quality and satisfaction level as regular face-to-face consultations.