Objective assessment of total laparoscopic hysterectomy: Development and validation of a feasible rating scale for formative and summative feedback.

OBJECTIVES: The aims of the study were to develop and gather validity evidence for a feasible rating scale for formative and summative assessment of total laparoscopic hysterectomy in the operating theatre. STUDY DESIGN: The study was a prospective observer-blinded cohort study. The rating scale was developed according to the generic format of Objective Structured Assessment of Technical Skills. We applied the contemporary framework of validity to examine validity evidence of the content, response process, internal structure, relationship to other variables, and consequences. Two experienced gynecologists constructed a preliminary version of the rating scale, which was reviewed by a multicentre team of experienced gynecologists in a modified Delphi process. The surgeons (beginners and experienced surgeons) were video recorded during live performance of total laparoscopic hysterectomies. Two blinded raters evaluated the performances independently using the rating scale. Internal consistency reliability and interrater reliability were calculated as measures of internal structure. The performances of the two groups were compared and a pass/fail score was set to show the consequences of the rating scale. RESULTS: The content of the rating scale was defined during three Delphi rounds and upon agreement comprised of 12 items. Sixteen participants including 8 beginners and 8 experienced surgeons performed total laparoscopic hysterectomies. The internal consistency reliability of the items was 0.95 (Cronbach's alpha), and the interrater reliabilities (Intraclass Correlation Coefficient, absolute agreement) were 0.996 for one rater and 0.998 for two raters (P < 0.001 for all correlations). The beginners' mean performance score was 19.2 (SD 7.1) and the experienced surgeons' score was 36.4 (SD 3.9); the groups performed statistically significantly different (P < 0.001). The pass/fail score was 29.3 with no false positives and no false negatives. CONCLUSION: With this study, a feasible rating scale for the objective assessment of total laparoscopic hysterectomy was developed with sound validity evidence. The rating scale is suitable for both formative and summative feedback in the commencement of surgical training in gynecology.

Quality of life, urogynecological morbidity, and lymphedema after radical vaginal trachelectomy for early-stage cervical cancer.

OBJECTIVE: Radical vaginal trachelectomy (RVT) offers a possibility for future childbearing for young women with early-stage cervical cancer. However, the literature on quality of life and self-reported morbidity in patients undergoing RVT is scarce. The aim of this study was to prospectively assess quality of life after RVT with focus on urogynecological morbidity and lymphedema. Furthermore, the aim of this study was to compare results with those in women treated with radical abdominal hysterectomy (RAH) and with age-matched control women from the general population. METHODS AND MATERIALS: Eighteen patients with early-stage cervical cancer operated with RVT were prospectively included and assessed preoperatively, 3, 6, and 12 months postoperatively using validated questionnaires. Thirty-two patients treated with RAH were included consecutively and assessed once at 12 months postsurgery, whereas an age-matched control group of 30 healthy women was assessed once. RESULTS: Fifty percent of the RVT group and 41% of the RAH reported any grade of incomplete bladder emptying problems at 1 year postsurgery assessment. Eleven percent of the RVT patients and 12.5% of the RAH patients reported severe lymphedema of the legs as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module. The Global Health Status scores of the RVT patients improved over time but were significantly lower than in the healthy controls during the entire observation time (P = 0.029). CONCLUSIONS: Patients treated with RVT for early-stage cervical cancer had persistent bladder emptying problems and lymphedema comparable to those experienced by patients treated with RAH and significantly higher than those reported by healthy control women.

Successful delivery after vaginal occlusion in addition to cerclage in a trachelectomy patient with recurrent second trimester pregnancy loss: a case report.

KEY CLINICAL MESSAGE: Pregnancy outcome after trachelectomy has high risk of complications such as second trimester pregnancy loss and preterm birth. We report beneficial effect of a simple procedure of vaginal occlusion in addition to cerclage in a patient with trachelectomy and two prior second trimester pregnancy losses.

Differences in regional diagnostic strategies and in intended versus actual first-line treatment of patients with advanced ovarian cancer in Denmark.

BACKGROUND: Triage of patients with ovarian cancer to primary debulking surgery (PDS) or neoadjuvant chemotherapy (NACT) is challenging. In Denmark, the use of NACT has increased, but substantial differences in the use of NACT or PDS exist among centers. We aimed to characterize the differences between intended and actual first-line treatments in addition to the differences in the triage process among the centers and to evaluate the different diagnostic modalities and the clinical aspects' influence in the triage process. MATERIALS AND METHODS: From 4 centers, forms containing data about the diagnostic process and intended treatment were prospectively collected and merged with data from the Danish Gynecological Cancer Database and medical records. RESULTS: Of the 671 completed forms, 540 patients had stage IIIC or IV epithelial ovarian cancer. Of the 238 (44%) referred to PDS, 91% received PDS and 4% never had debulking surgery. Of the 288 patients (53%) referred to NACT, 44% were never debulked. Fourteen patients (3%) were referred to palliative treatment. The use of different imaging modalities, diagnostic laparoscopy, and laparotomy varied significantly among the centers. Diagnostic surgical procedures were considered to be most influential in the triage process. Regardless of the intended first-line treatment or center, the tumor size and dissemination was the most influential clinical aspect. CONCLUSIONS: In Denmark, substantial differences exist between intended and actual first-line treatments as well as in the diagnostic process and use of NACT, calling for further discussion on diagnostic strategy and therapeutically approach for patients with advanced ovarian cancer.

Sexual functioning and vaginal changes after radical vaginal trachelectomy in early stage cervical cancer patients: a longitudinal study.

INTRODUCTION: Radical vaginal trachelectomy (RVT) offers low complication rate, good survival, and possibility for future childbearing for young women with early stage cervical cancer. However, the literature on quality of life (QOL) and sexual functioning in patients undergoing RVT is scarce. AIM: The aims of this study were to prospectively assess sexual function after RVT and to compare scores of sexual function in patients operated by RVT and radical abdominal hysterectomy (RAH) with those of age-matched control women from the general population. METHODS: Eighteen patients with early stage cervical cancer operated with RVT were prospectively included and assessed preoperatively, and 3, 6, and 12 months postoperatively using validated questionnaires. RAH patients were included consecutively and assessed once at 12 months postsurgery, while an age-matched control group of 30 healthy women was assessed once. MAIN OUTCOME MEASURE: Sexual dysfunction total score as measured by the Female Sexual Function Index (FSFI) was the main outcome measure. RESULTS: During the 12 months posttreatment, RVT patients tended to have persistent sexual dysfunction as measured by FSFI (mean overall score <26.55 at each assessment) and Female Sexual Distress Scale (mean overall score > 11). Sexual worry (P < 0.001) and lack of sexual desire (P = 0.038) were more frequently reported among patients in both treatment groups compared with control women. Sexual activity increased significantly during the observation time for the RVT group (P = 0.023) and reached that of healthy women. Global Health Status score improved over time for the RVT group but never reached that of healthy control women (P = 0.029). CONCLUSIONS: Our data suggest that patients treated with RVT for early stage cervical cancer experience persistent sexual dysfunction up to one year post surgery influencing negatively on their QOL.

Does neoadjuvant chemotherapy impair long-term survival for ovarian cancer patients? A nationwide Danish study.

OBJECTIVE: In Denmark, the proportion of women with ovarian cancer treated with neoadjuvant chemotherapy (NACT) has increased, and the use of NACT varies among center hospitals. We aimed to evaluate the impact of first-line treatment on surgical outcome and median overall survival (MOS). METHODS: All patients treated in Danish referral centers with stage IIIC or IV epithelial ovarian cancer from January 2005 to October 2011 were included. Data were obtained from the Danish Gynecological Cancer Database, the Danish National Patient Register and medical records. RESULTS: Of the 1677 eligible patients, 990 (59%) were treated with primary debulking surgery (PDS), 515 (31%) with NACT, and 172 (10%) received palliative treatment. Of the patients referred to NACT, 335 (65%) received interval debulking surgery (IDS). Patients treated with NACT-IDS had shorter operation times, less blood loss, less extensive surgery, fewer intraoperative complications and a lower frequency of residual tumor (p < 0.05 for all). No difference in MOS was found between patients treated with PDS (31.9 months) and patients treated with NACT-IDS (29.4 months), p = 0.099. Patients without residual tumor after surgery had better MOS when treated with PDS compared with NACT-IDS (55.5 and 36.7 months, respectively, p = 0.002). In a multivariate analysis, NACT-IDS was associated with increased risk of death after two years of follow-up (HR: 1.81; CI: 1.39-2.35). CONCLUSIONS: No difference in MOS was observed between PDS and NACT-IDS. However, patients without residual tumor had superior MOS when treated with PDS, and NACT-IDS could be associated with increased risk of death after two years of follow-up.

Development and validation of a theoretical test in basic laparoscopy.

BACKGROUND: Testing of knowledge is an important component in a successful skills curriculum. Nonetheless, structured testing of basic procedure-relevant knowledge in the surgical domains is not ordinary practice. A regional need assessment showed insufficient knowledge regarding basic laparoscopy for first-year residents in obstetrics and gynecology. This study therefore aimed to develop and validate a framework for a theoretical knowledge test, a multiple-choice test, in basic theory related to laparoscopy. METHODS: The content of the multiple-choice test was determined by conducting informal conversational interviews with experts in laparoscopy. The subsequent relevance of the test questions was evaluated using the Delphi method involving regional chief physicians. Construct validity was tested by comparing test results from three groups with expected different clinical competence and knowledge levels: senior medical students, first-year residents, and chief physicians. RESULTS: The four conversational interviews resulted in the development of 47 test questions, which were narrowed down to 37 test questions after two Delphi rounds involving 12 chief physicians. Significant differences were found between the test scores from the senior medical students (n = 14) and the first-year residents (n = 52) (median test scores, 18 vs. 24, respectively; p = 0.001), and between the first-year residents and the chief physicians (n = 12) (median test scores, 24 vs. 33, respectively; p = 0.001). Internal consistency (Cronbach's alpha) was 0.82. There was no evidence of differential item functioning between the three groups tested. CONCLUSIONS: A newly developed knowledge test in basic laparoscopy proved to have content and construct validity. The formula for the development and validation of a theoretical test could potentially be used for any topics that require structured testing of knowledge.

Neoadjuvant chemotherapy as ovarian cancer treatment: ever more used with major regional differences.

INTRODUCTION: The traditional first-line treatment for patients with advanced ovarian cancer with primary debulking surgery (PDS) and adjuvant chemotherapy is controversial as some authors report a potential benefit from the alternative treatment with neoadjuvant chemotherapy (NACT) and interval debulking surgery. The aim of this study was to investigate the use of NACT in Denmark in regard to increased use and regional differences. MATERIAL AND METHODS: Stage IIIC and IV ovarian cancer patients treated in the five Danish tertiary referral centres in the 2005-2010-period were included. The study is based on validated data from The Danish Gynaecological Cancer Database. RESULTS: Of the 1,367 eligible patients 1,069 were treated with PDS and 298 with NACT. In 2005-2007, 11% of patients were treated with NACT. In 2008-2010, this percentage had risen to 30% (p < 0.00001). Between the five referral centres, the use of NACT ranged from 6% to 41% in 2005-2010 (p < 0.00001); from 1 % to 31% in 2005-2007 (p < 0.00001); from 10% to 48% in 2008-2010 (p < 0.00001) and from 9% to 48% in 2010 (p < 0.0008). Patients treated with NACT were significantly older, had inferior ASA scores and Eastern Cooperative Oncology Group performance status compared with the patients from the PDS group. There was no difference between treatments in regard to body mass index, stage IV disease or patients with no co-morbidity. CONCLUSION: The use of NACT as first-line treatment tripled from 2005-2010, but the regional variability was large which calls for a uniform agreement on treatment principles and evaluation. FUNDING: This study was financially supported by grants from The Copenhagen University Hospital Research Foundation, Manufacturer Einar Willumsens Memorial Trust, The Capital Region of Denmark Research Foundation, The Arvid Nilsson Foundation, The King Christian X Foundation, The Dagmar Marshall Foundation, The Danish Research Foundation, and The Hans and Nora Buchard Foundation. TRIAL REGISTRATION: not relevant.

Trachelectomy for cancer of the cervix: dargent's operation. Vaginal hysterectomy for early cancer of the cervix stage IA1 and CIN III.

Radical vaginal trachelectomy is today an established method of treating selected women with cervical cancer stage IA2 and IB1, with tumour size less than 2cm without precluding future childbearing. This technique has been used for more than 20 years with reassuring oncological safety and excellent obstetrical outcomes. The procedure is a combination of laparoscopy for pelvic lymphadenectomy and challenging classic vaginal surgery to resect the tumour, part of the parametrium and upper vagina. Complications are in the range of 8-13%. Recurrence and death occur in 5 and 3%, respectively, as good as figures for radical hysterectomy. Rate of second trimester miscarriage is 8-10%, and that of preterm delivery 20-30%. More than 900 cases with 200 children are now reported in the published literature.

Autotransplantation of cryopreserved ovarian tissue in 12 women with chemotherapy-induced premature ovarian failure: the Danish experience.

OBJECTIVE: To describe a cohort of 12 Danish women who received autotransplantation of frozen-thawed cryopreserved ovarian tissue because of premature ovarian failure after cancer treatment. DESIGN: Retrospective study. SETTING: University hospitals. PATIENT(S): Twelve women with autotransplanted frozen-thawed ovarian tissue. INTERVENTION(S): Monitoring of hormonal parameters and results of 56 IVF cycles in 10 women. MAIN OUTCOME MEASURE(S): Levels of gonadotropins and sex steroids, functional life span of the grafts, and results of IVF. RESULT(S): All 12 women regained ovarian function between 8 and 26 weeks (mean 19 weeks) after transplantation. Ten women underwent a total of 56 IVF cycles, 76 follicles developed, 49 oocytes were aspirated, 18 were fertilized, and 16 embryos were transferred resulting in six pregnancies: two biochemical, one clinical that miscarried in week 7, and two ongoing resulting in the delivery of two healthy infants born at term to two women. One of these women subsequently conceived spontaneously and delivered another healthy infant. The life span of the transplanted tissue has been between 6 months and still functioning after 54 months. CONCLUSION(S): Autotransplantation consistently leads to recovery of ovarian function after treatment-induced ovarian failure. Four women became pregnant, after IVF or spontaneously, resulting in the delivery of three healthy infants.

Effect of virtual reality training on laparoscopic surgery: randomised controlled trial.

OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously validated general and task specific rating scale. The secondary outcome measure was operation time in minutes. RESULTS: The simulator trained group (n=11) reached a median total score of 33 points (interquartile range 32-36 points), equivalent to the experience gained after 20-50 laparoscopic procedures, whereas the control group (n=10) reached a median total score of 23 (22-27) points, equivalent to the experience gained from fewer than five procedures (P<0.001). The median total operation time in the simulator trained group was 12 minutes (interquartile range 10-14 minutes) and in the control group was 24 (20-29) minutes (P<0.001). The observers' inter-rater agreement was 0.79. CONCLUSION: Skills in laparoscopic surgery can be increased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved. Simulator training should be considered before trainees carry out laparoscopic procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT00311792.

Vaginal rupture caused by transvaginal ultrasonography in follow-up for ovarian cancer.

Vaginal rupture is a rare complication of hysterectomy. It is, among others, related to age and the incidence is higher in postmenopausal women. The rupture can occur spontaneously or in relation to clinical follow-up. In ovarian cancer the follow-up after surgery includes clinical examination, cancer antigen (CA)-125, and transabdominal and transvaginal ultrasonography. We experienced vaginal rupture in three patients with ovarian cancer. All patients had undergone surgery for ovarian cancer and were receiving chemotherapy. The rupture occurred shortly after transvaginal ultrasonography, performed by separate radiologists specialised in ultrasonography. All patients had acute surgery without any complications. Caution should be taken when performing transvaginal ultrasonography in hysterectomised patients and the complication of vaginal rupture should always be borne in mind.

Two successful pregnancies following autotransplantation of frozen/thawed ovarian tissue.

BACKGROUND: Cryopreservation of the ovarian cortex with subsequent autotransplantation has, on an experimental basis, been performed to preserve fertility in women being treated for a malignant disease. The present study reports ovarian activity and pregnancies following autotransplantation of frozen/thawed ovarian tissue. METHODS: One complete ovary was cryopreserved from each of six patients who were 26-35 years old prior to treatment. Tissue from three of the patients was transported 4-5 h on ice prior to cryopreservation. After a period of 17-32 months, orthotopic autotransplantation was performed replacing 20-60% of the tissue. Two patients received additional heterotopic transplants. RESULTS: In all cases, the tissue restored menstrual cyclicity 14-20 weeks following transplantation. Four of the six women conceived following assisted reproduction: two women (who had the tissue transported 4-5 h prior to cryopreservation) each, based on the orthotopic transplanted tissue, delivered one healthy child (February 2007 and January 2008); one woman miscarriaged in gestational Week 7; and the other had a positive hCG test but no clinical pregnancy. The remaining two women did not become pregnant. CONCLUSIONS: Two additional healthy children have been born as a result of the ovarian cryopreservation procedure. In both cases, the ovarian tissue was transported 4-5 h prior to freezing demonstrating that hospitals may offer cryopreservation without having the necessary expertise locally.

Organisation and quality of primary surgical intervention for ovarian cancer in Denmark.

BACKGROUND: The positive effect on survival of maximal primary cytoreductive surgery for ovarian cancer is well established, and the highest rates of optimal cytoreduction are achieved by gynecological oncologists. Danish women have not only one of the highest incidences of ovarian cancer, but also the highest mortality rate. From 1981 to 1989, the overall Danish optimal debulking rate was 25% in patients with stage III and IV tumors. The primary aim of the present study was, therefore, to evaluate the organisation and quality of current primary surgical intervention for ovarian cancer in Denmark. METHODS: All women diagnosed with epithelial ovarian carcinoma (DC56) were identified through the Danish National Patient Registry during the study period from 1 July 2002 to 31 December 2003, and surgical notes and histopathology were evaluated by a board of 7 gynecological-oncologists, focusing on maximal cytoreduction. RESULTS: For stage III, the nationwide optimal debulking rate was 39%, significantly higher in the major hospitals (49%) versus other hospitals (29%) (p<0.005). In 19% of cases, there was insufficient information to evaluate debulking from the surgical notes, significantly less at the major hospitals versus other hospitals (12 versus 25%, p<0.001). CONCLUSIONS: In Denmark, the quality of the primary surgical intervention for ovarian cancer is not optimal. In order to enhance survival, compliance with international guidelines and improved registration of the surgical procedures in clinical databases are mandatory.

The diagnostic value of PET/CT scanning in patients with cervical cancer: a prospective study.

OBJECTIVE: To investigate the clinical value of PET/CT as a supplement to FIGO staging in patients with cervical cancer stage >or=1B. METHODS: This prospective study included 120 consecutive patients. After staging, a whole-body PET/CT scan was performed and these examinations were divided into two groups: (1) patients suitable for radical hysterectomy including lymph node dissection and (2) patients referred to combined chemo/radiation therapy. The results were compared to histopathological findings and/ or follow-up. RESULTS: Twenty-seven patients underwent radical surgery; four of these had PET/CT scans revealing pathological foci in the pelvis. Three (11%) were true positive; one was false positive. Twenty-two patients had true negative PET/CT scans concerning pelvic lymph nodes. One patient had a false negative node. For these patients, we found the positive predictive value (PPV) to be 75%, negative predictive value (NPV) 96%, sensitivity 75%, specificity 96%. Regarding para-aortal nodal disease in the total population of 119 patients, 15 patients had true positive scans. The number of true negatives was 103, resulting in PPV 94%, NPV 100%, sensitivity 100% and specificity 99%. PET/CT scans showed distant metastases in 19 patients, 10 were true positive and nine were false positive. The remaining 100 patients were considered true negative for distant metastases and for these patients, we found PPV 63%, NPV 100%, sensitivity 100% and specificity 94%. CONCLUSIONS: Whole-body FDG PET/CT scanning for newly diagnosed cervical cancer FIGO stage >or=1B has a high sensitivity and specificity, and can be a valuable supplement to the FIGO staging procedure.

[Accelerated course after operation for ovarian cancer]. / Accelereret forløb efter operation for ovariecancer.

INTRODUCTION: Introduction of principles for postoperative multimodal rehabilitation (fast track surgery) has decreased hospital stay from about 8-10 days to 2-4 days after colonic resection. The aim of this study was to investigate the effect of a similar fast track regimen in patients operated for ovarian cancer. METHOD: 72 consecutive patients operated with a conventional perioperative treatment regimen (group 1) were compared with the initial 69 consecutive patients (group 2) with a multimodal rehabilitation regimen and the next 50 consecutive patients (group 3) where the fast track regimen was implemented as a routine. RESULTS: Patients demographics and surgical characteristics were comparable between groups. Median postoperative hospital stay was reduced from six days in group 1, to five days in group 2, and four days in group 3 (p < 0,05). Surgical complications were similar while medical complications were reduced from 12% to 1% (p < 0,05) and readmissions from 10% to 2% (p < 0,05) with the fast track regimen. CONCLUSION: Principles for postoperative multimodal rehabilitation from colonic surgery lead to faster rehabilitation, decreased risk of medical complications and hospital stay in patients operated for ovarian cancer.

The effect of accelerated rehabilitation on recovery after surgery for ovarian malignancy.

BACKGROUND: In patients undergoing colonic surgery the postoperative hospital stay has been reduced from 8-12 days to 2-4 days with multimodal rehabilitation programs. The aim of this study was to evaluate the postoperative outcome after surgery for ovarian malignancy with conventional care compared to fast-track multimodal rehabilitation. METHODS: Seventy-two consecutive patients receiving conventional care (group 1) were compared with 69 consecutive patients receiving multimodal, fast-track rehabilitation with a planned care program including continuous epidural analgesia, early oral feeding and mobilization (group 2) in the same department. Outcome was postoperative hospital stay and morbidity during the first postoperative month. RESULTS: Median age was 63 years (group 1) and 62 years (group 2). Median postoperative hospital stay was reduced from 6 days in group 1 (mean 7.3) to 5 days in group 2 (mean 5.4) (p < 0.05). There was no difference in the overall complication rate, although severe medical complications were reduced in group 2 (14% versus 2%; p < 0.01). Readmission rate was 10% in group 1 and 3% in group 2 (p > 0.05). CONCLUSIONS: The concept of fast-track multimodal rehabilitation appears to be beneficial in patients operated for ovarian malignancy, as hospital stay and medical morbidity are reduced.

[Fertility preserving surgery for carcinoma of the cervix is now possible]. / Fertilitetsbevarande kirurgi vid livmoderhalscancer nu möjlig.

This article describes the first Swedish experience with fertility preserving surgery according to the technique of Dargent. Minimally invasive methods gain acceptance in the treatment of other tumours and this method seems to treat adequately and preserve function. The literature is reviewed and discussed. In Sweden about 25-40 women under 30 years of age are each year diagnosed with cancer of the cervix. Three women with early cancer of the cervix were treated and one successful pregnancy reported.