Recommendations for a standardised educational program in robot assisted gynaecological surgery: Consensus from the Society of European Robotic Gynaecological Surgery (SERGS).

BACKGROUND: The Society of European Robotic Gynaecological Surgery (SERGS) aims at developing a European consensus on core components of a curriculum for training and assessment in robot assisted gynaecological surgery. METHODS: A Delphi process was initiated among a panel of 12 experts in robot assisted surgery invited through the SERGS. An online questionnaire survey was based on a literature search for standards in education in gynaecological robot assisted surgery. The survey was performed in three consecutive rounds to reach optimal consensus. The results of this survey were discussed by the panel and led to consensus recommendations on 39 issues, adhering to general principles of medical education. RESULTS: On review there appeared to be no accredited training programs in Europe, and few in the USA. Recommendations for requirements of training centres, educational tools and assessment of proficiency varied widely. Stepwise and structured training together with validated assessment based on competencies rather than on volume emerged as prerequisites for adequate and safe learning. An appropriate educational environment and tools for training were defined. Although certification should be competence based, the panel recommended additional volume based criteria for both accreditation of training centres and certification of individual surgeons. CONCLUSIONS: Consensus was reached on minimum criteria for training in robot assisted gynaecological surgery. To transfer results into clinical practice, experts recommended a curriculum and guidelines that have now been endorsed by SERGS to be used to establish training programmes for robot assisted surgery.

Development of Peritoneal Carcinoma in women diagnosed with Serous Tubal Intraepithelial Carcinoma (STIC) following Risk-Reducing Salpingo-Oophorectomy (RRSO).

INTRODUCTION: The management of Serous Tubal Intraepithelial Carcinoma (STIC) found at the time of Risk-Reducing Salpingo-Oophorectomy (RRSO) remains unclear. We set out to analyse the incidence of peritoneal carcinomas developed after prophylactic surgery and to formulate further guidance for these patients. METHODS: This is a retrospective study of 300 consecutive RRSO performed at the Royal Marsden Hospital between January 2008 and January 2017. RESULTS: The median age at RRSO was 47.8 years (range 34 to 60 years) and median BMI was 26.2 kg/m2 (range 16 to 51 kg/m2). A total of 273 patients (91%) were tested for BRCA mutations. Of these, 124 (45.4%) had a BRCA 1 mutation, 118 (43.2%) had a BRCA 2 mutation, 2 (0.7%) had both a BRCA 1 and a BRCA 2 mutation and 29 (10.6%) had no BRCA mutation detected. Isolated STIC lesions were identified in 7 cases (2.3%) and p53 signatures in 75 cases (25%). There were five (1.6%) incidental tubal carcinomas and one (0.3%) ovarian carcinoma at the time of surgery. Two (28.6%) of the 7 patients with STIC identified following RRSO had high grade serous peritoneal carcinoma diagnosed at 53 and 75 months. One (0.3%) patient from the other 287 patients from our series with no STIC diagnosis or incidental carcinomas at RRSO developed high grade serous carcinoma of peritoneal origin after 92 months. CONCLUSION: This study demonstrates that when a STIC lesion is identified following RRSO there is a significantly higher risk of a subsequent peritoneal cancer. Although there is no published consensus in literature, we recommend that consideration should be given for long term follow-up if a STIC lesion is identified at RRSO.

Influencing surgical management in patients with carcinoma of the cervix using a T2- and ZOOM-diffusion-weighted endovaginal MRI technique.

BACKGROUND: Endovaginal MRI (evMRI) at 3.0-T with T2-weighted (T2-W) and ZOnal Oblique Multislice (ZOOM)-diffusion-weighted imaging (DWI) potentially improves the detection of stage Ia/Ib1 cervical cancer. We aimed to determine its sensitivity/specificity, document tumour-to-stromal contrast and establish the effect of imaging on surgical management. METHODS: Following ethical approval and written informed consent, 57 consecutive patients with suspected stage Ia/Ib1 cervical cancer underwent evMRI at 3.0-T using T2-W and ZOOM-DWI. Sensitivity/specificity were calculated against histopathology for two independent observers. Tumour-to-stromal contrast was determined on T2-W, and diffusion-weighted (b=800 s mm(-2)) images and apparent diffusion coefficients (ADCs) were recorded. In patients due for radical vaginal trachelectomy (RVT), change of surgical management based on imaging findings was documented. RESULTS: Sensitivity/specificity for detecting tumour was the following: reporting read 88.0/81.8%, anonymised read 92.0/81.8% (observer 1); 84.0/72.7% (observer2; median tumour volume=1.7 cm(3)). Intraobserver agreement was excellent (kappa=0.89) and the interobserver agreement was good (kappa=0.65). Tumour-to-stromal contrast was greater on ZOOM-DWI compared with T2-W images (3.35±2.36 vs 1.39±0.95; P<0.0004). Tumour and stromal ADCs were significantly different (P<0.00001). In 31 patients due for RVT, evMRI altered surgical management in 12 (38.7%) cases (10 cone-biopsy, 2 chemoradiotherapy). CONCLUSION: T2-W+ZOOM-DWI evMRI has high sensitivity/specificity for detecting stage Ia/Ib1 cervical tumours; in patients due for RVT, the surgical management was altered in ∼39%.

Laparoscopic staging for apparent early stage ovarian or fallopian tube cancer. First case series from a UK cancer centre and systematic literature review.

OBJECTIVE: To describe the experience of laparoscopic staging of apparent early stage adnexal cancers. METHODS: Prospectively collected data on women who had laparoscopic staging for apparent early stage adnexal cancers from May 2008 to September 2012 was reviewed. All women had had a prior surgical procedure at which the diagnosis was made, without comprehensive staging. A systematic MEDLINE search from 1980 to 2012 for publications on laparoscopic staging was performed. RESULTS: Thirty-five women had laparoscopic staging. Median age was 45 years (range 21-73). Median operative time was 210 min (range 90-210). Four intra-operative and one post-operative complication occurred; overall complication rate 5/35 (14%). One vena cava and one transverse colon injury underwent laparotomies for repair. Laparotomy conversion rate 2/35 (6%). Following laparoscopic staging, the cancer was upstaged for eight (23%) women; microscopic omental involvement (four women), pelvic lymph node involvement (two women), para-aortic lymph node involvement (one woman) and contra-lateral ovarian involvement (one woman). After follow up for a median of 18 months (range 3-59) the disease free survival was 94% and overall survival was 100%. Nine studies were identified on laparoscopic staging of adnexal cancer, of which this is the largest single institution series. CONCLUSIONS: This study adds to the evidence that laparoscopic staging is at least as safe as staging by laparotomy with appropriate and similar oncological outcomes, but with the advantages of minimal access surgery. We therefore advocate the use of laparoscopy to achieve surgical staging for women with presumed early stage adnexal cancer.

Outcomes of surgical management of bowel obstruction in relapsed epithelial ovarian cancer (EOC).

OBJECTIVE: To describe the outcomes of surgical management of bowel obstruction in relapsed epithelial ovarian cancer (EOC) so as to define the criteria for patient selection for palliative surgery. METHODS: 90 women with relapsed EOC underwent palliative surgery for bowel obstruction between 1992 and 2008. RESULTS: Median age at time of surgery for bowel obstruction was 57 years (range, 26 to 85 years). All patients had received at least one line of platinum-based chemotherapy. Median time from diagnosis of primary disease to documented bowel obstruction requiring surgery was 19.5 months (range, 29 days-14 years). Median interval from date of completed course of chemotherapy preceding surgery for bowel obstruction was 3.8 months (range, 5 days-14 years). Ascites was present in 38/90(42%). 49/90(54%) underwent emergency surgery for bowel obstruction. The operative mortality and morbidity rates were 18% and 27%, respectively. Successful palliation, defined as adequate oral intake at least 60 days postoperative, was achieved in 59/90(66%). Only the absence of ascites was identified as a predictor for successful palliation (p=0.049). The median overall survival (OS) was 90.5 days (range, <1 day-6 years). Optimal debulking, treatment-free interval (TFI) and elective versus emergency surgery did not predict survival or successful palliation from surgery for bowel obstruction (p>0.05). CONCLUSION: Surgery for bowel obstruction in relapsed EOC is associated with a high morbidity and mortality rate especially in emergency cases when compared to other gynaecological oncological procedures. Palliation can be achieved in almost two thirds of cases, is equally likely in elective and emergency cases but is less likely in those with ascites.

Comparing the learning curve for robotically assisted and straight stick laparoscopic procedures in surgical novices.

INTRODUCTION: Robotically assisted laparoscopic surgery has a different learning curve to straight stick laparoscopic surgery. The learning curve for novices is likely to be different to that for experienced surgeons. We assessed the early learning curve for trainees with 18 months or less of surgical experience. METHODS: Six surgical novices performed 120 exercises using laparoscopic instruments and a DaVinci S robot. The exercise comprised cutting out a computer-generated paper circle. Time to completion, number of instrument changes and accuracy were compared (Kruskal-Wallis test). RESULTS: Trainees required significantly less time using the robot (326 vs. 433 s; p < 0.0001); recorded fewer mistakes (1 vs. 4.5; p < 0.0001) and fewer instrument changes (1 vs. 3; p < 0.0001). Significant improvement was demonstrated in time, number of mistakes and instrument changes for robotically-assisted laparoscopic surgery. CONCLUSION: For surgical novices tested on an in vitro dexterity exercise, a robotically assisted laparoscopic system offers a shorter learning curve and improved accuracy compared to straight stick surgery.

Glove perforations during open surgery for gynaecological malignancies.

OBJECTIVE: To audit glove perforations at laparotomies for gynaecological cancers. SETTING: Gynaecological oncology unit, cancer centre, London. DESIGN: Prospective audit. SAMPLE: Twenty-nine laparotomies for gynaecological cancers over 3 months. METHODS: Gloves used during laparotomies for gynaecological cancer were tested for perforations by the air inflation and water immersion technique. Parameters recorded were: type of procedure, localisation of perforation, type of gloves, seniority of surgeon, operation time and awareness of perforations. MAIN OUTCOME MEASURE: Glove perforation rate. RESULTS: Perforations were found in gloves from 27/29 (93%) laparotomies. The perforation rate was 61/462 (13%) per glove. The perforation rate was three times higher when the duration of surgery was more than 5 hours. The perforation rate was 63% for primary surgeons, 54.5% for first assistant, 4.7% for second assistant and 40.5% for scrub nurses. Clinical fellows were at highest risk of injury (94%). Two-thirds of perforations were on the index finger or thumb. The glove on the nondominant hand had perforations in 54% of cases. In 50% of cases, the participants were not aware of the perforations. There were less inner glove perforations in double gloves compared with single gloves (5/139 versus 26/154; P = 0.0004, OR = 5.4, 95% CI 1.9-16.7). The indicator glove system failed to identify holes in 44% of cases. CONCLUSIONS: Glove perforations were found in most (93%) laparotomies for gynaecological malignancies. They are most common among clinical fellows, are often unnoticed and often not detected by the indicator glove system.

The use of inferior vena caval filters prior to major surgery in women with gynaecological cancer.

OBJECTIVE: To evaluate the use of inferior vena caval filters (IVCF) prior to surgery in women with gynaecological cancer and venous thromboembolism (VTE). DESIGN: Retrospective review of medical notes and electronic records. SETTING: Gynaecological oncology cancer centre. POPULATION: Women with gynaecological cancer and VTE requiring major surgery. METHODS: A retrospective analysis was performed on women treated for gynaecological malignancies who had had VTE, and an IVCF placed before major abdominal surgery were reviewed during the period 1996-2006. MAIN OUTCOME MEASURES: Safety of IVCF placement and retrieval, peri-operative morbidity and incidence of further VTE. RESULTS: The median age was 66 years (range 30-84 years). Of the 39 women, 35 (90%) women had a primary cancer diagnosis and 4 (10%) had recurrent disease. Twenty-two women had ovarian cancer, 2 had borderline ovarian tumours, 9 had uterine cancer, 5 had cervical cancer and 1 woman had concurrent ovarian and endometrial cancers. The recurrent cancers were two cervical, one ovarian and one uterine. The IVCF used were either of the permanent or retrievable type, the latter being more commonly used in younger women. All filters were placed without morbidity, and none of these women who then underwent major abdominal surgery had VTE complications. In 43.6% of women (n = 17), surgery was performed within 6 weeks of the diagnosis of VTE. All women received perioperative anticoagulation in the form of subcutaneous low-molecular-weight heparin. Three retrievable filters were uneventfully removed postoperatively. No filter-related problems occurred. CONCLUSIONS: Surgery in women with gynaecological cancer and life-threatening VTE is feasible with preoperative IVCF placement. The use of IVCF was safe with no worsening of the VTE, and without surgical or filter-related problems. A short interval between the diagnosis of VTE and surgery was not associated with increased perioperative morbidity.

Assessment of an in vitro model for laparoscopic pelvic lymphadenectomy.

An in vitro model was developed for laparoscopic pelvic lymphadenectomy. A construct validity study was performed comparing experienced laparoscopic surgeons with inexperienced trainees. Outcome measures included global and task-orientated scoring and data from electromagnetic motion analysis of hands. Marking was performed by three independent surgeons using video playback. A significant difference was found in the time taken, number of movements made and total distance travelled between the groups. Both scoring systems discriminated between the expert and inexperienced group, demonstrating the model's construct validity.

Radical vaginal trachelectomy as a fertility-sparing procedure in women with early-stage cervical cancer-cumulative pregnancy rate in a series of 123 women.

OBJECTIVE: To analyse the fertility rates, complications and recurrences in a group of women who have undergone radical vaginal trachelectomy and pelvic lymphadenectomy for early-stage cervical cancer. DESIGN: An observational series. SETTING: A Gynaecological Oncology Centre. POPULATION: One hundred and twenty-three consecutive women who underwent radical vaginal trachelectomy and pelvic lymphadenectomy for early-stage cervical cancer. METHODS: Data were collected prospectively. MAIN OUTCOME MEASURES Complications, recurrences, pregnancies and live births are presented as percentages of the total population. Fertility is presented as a 5-year cumulative rate, with women attempting to conceive as the denominator. RESULTS: A total of 123 women were followed up for an average of 45 months. Eleven (8.9%) had completion treatment (two radical hysterectomies and nine chemoradiotherapy) at the time of initial treatment. There were three recurrences (2.7%) among the women who did not have completion treatment and two (18.2%) in those who did. There were 6 perioperative and 26 postoperative complications. Sixty-three women attempted pregnancy. There were 55 pregnancies in 26 women and 28 live births in 19. Three women had continuing pregnancies. The 5-year cumulative pregnancy rate among women trying to conceive was 52.8%. All but two women were delivered by classical caesarean section and seven (25.0%) babies were born at 31+6 weeks or less. CONCLUSIONS: For selected women with early-stage cervical cancer, radical vaginal trachelectomy and pelvic lymphadenectomy are fertility-sparing options, with a low incidence of recurrence and acceptable cumulative conception rates. Complications are few, although there is a high premature labour and miscarriage rate among pregnant women.

Routine computerized tomography scanning, groin ultrasound with or without fine needle aspiration cytology in the surgical management of primary squamous cell carcinoma of the vulva.

We set out to study whether computerized tomography (CT) scanning of the vulva and the groin and groin ultrasound scanning (USS) alone or with fine needle aspiration cytology (FNAC) (USS/FNAC) influenced or could influence the surgical management of primary squamous cell carcinoma of the vulva (SCCaV). Forty-four patients underwent surgery for primary SCCaV following radiologic imaging by one or more modalities. Patient details included the clinical assessment of the carcinoma, radiologic findings, the operation performed, and whether the decision regarding the type and extent of surgery for the vulval carcinoma and, in particular, for the groin node dissection was or could be influenced by the radiologic findings. The age range was 38-87 years, with a median of 74 years. A total of 75 groin dissections were performed. Twenty-five of the 44 patients (56.8%) did not have groin node metastasis, 14 had unilateral metastasis (31.8%), and 5 (11.4%) had bilateral metastasis. All cases with histologically proven nodal status were analyzed to compare the preoperative imaging status with the histology. The calculated sensitivity, specificity, negative predictive value, and positive predictive value for CT were 58%, 75%, 75%, and 58%, for USS alone-87%, 69%, 94%, and 48%, and for USS-guided FNAC-80%, 100%, 93%, and 100%, respectively. There was no patient in whom surgical planning for the vulval carcinoma or the groin nodes was or could be altered by the CT findings. The data do not support the routine use of CT scanning in patients with primary SCCaV, either in assessment of the primary vulval carcinoma or in detecting groin nodal metastases. For the groin nodes, USS/FNAC is superior to CT in assessing disease status. In contrast to CT, USS/FNAC may have a useful clinical role in the management of the groin nodes in vulval carcinoma.

Mucinous epithelial ovarian cancer: a separate entity requiring specific treatment.

PURPOSE: Invasive mucinous carcinoma of the ovary (mucinous epithelial ovarian cancer [mEOC]) is a histologic subgroup of epithelial ovarian cancer (EOC). Chemotherapy for mEOC is chosen according to guidelines established for EOC. The purpose of this study is to determine whether this is appropriate. PATIENTS AND METHODS: Women with advanced mEOC (International Federation of Gynecology and Obstetrics stage III or IV) who underwent first-line platinum-based chemotherapy were compared with women with other histologic subtypes of EOC in a case-controlled study. RESULTS: Eighty-one patients (27 cases, 54 controls) treated with platinum-based regimens were analyzed. The response rates for cases and controls were 26.3% (95% CI, 9.2% to 51.2%) and 64.9% (95% CI, 47.5% to 79.8%), respectively (P=.01). The odds ratio for complete or partial response to chemotherapy for mEOC was 0.19 (95% CI, 0.06 to 0.66; P=.009) compared with other histologic subtypes of EOC. Median progression-free survival was 5.7 months (95% CI, 1.9 to 9.6 months) versus 14.1 months (95% CI, 12.0 to 16.2 months; P<.001) and overall survival was 12.0 months (95% CI, 8.0 to 15.6 months) versus 36.7 months (95% CI, 25.2 to 48.2 months; P<.001) for cases and controls, respectively. The hazard ratio for progression and death was 2.94 (95% CI, 1.71 to 5.07; P<.001) and 3.08 (95% CI, 1.69 to 5.6; P<.001), respectively, for mEOC patients as compared with controls. CONCLUSION: Patients with advanced mEOC have a poorer response to platinum-based first-line chemotherapy compared with patients with other histologic subtypes of EOC, and their survival is worse. Specific alternative therapeutic approaches should be sought for this group of patients, perhaps involving fluorouracil-based chemotherapy.

Preoperative predictors of suboptimal primary surgical cytoreduction in women with clinical evidence of advanced primary epithelial ovarian cancer.

INTRODUCTION: Women with epithelial ovarian cancer (EOC) are conventionally treated with primary cytoreductive surgery. For those with a low probability of optimal primary surgical debulking, an alternative management option is primary chemotherapy with delayed primary surgery. Selection criteria are required to identify women who may benefit from this approach. PATIENTS AND METHODS: Patient age, presence of ascites, preoperative serum CA-125 level, surgical procedures performed, postoperative residual disease, FIGO stage, and histology data were collected on 97 women with preoperative clinical evidence of advanced EOC. Univariate and multivariate analysis was performed to identify which preoperative factors predict disease that will be suboptimally debulked. Receiver-operator curves were constructed for CA-125 level as a predictor for residual disease. RESULTS: The best predictor of disease suboptimally cytoreduced was serum CA-125 level (OR = 22.76, 95% CI = 7.13-72.69). Other predictive factors included age over 60 years (OR = 3.16, 95% CI = 1.04-9.56) and clinical evidence of ascites (OR = 3.30, 95% CI = 1.03-10.62). The optimal cut-off for serum CA-125 as a predictor of suboptimal debulking was 586 IU (sensitivity 80.0%, specificity 88.5%, PPV 85.7%). CONCLUSION: Serum CA-125 level is a reliable component of the preoperative assessment of women with EOC.

Influence of training on reliability of surgical knots.

OBJECTIVES: To determine whether trainees in obstetrics and gynaecology tie adequate surgical knots and to assess whether formal training improves knot tying skills. DESIGN: A comparative study assessing surgical knots before and after tuition. POPULATION: Fourteen trainees in a single obstetrics and gynaecology department. SETTING: A basic surgical skills workshop based in a London teaching hospital. METHODS: Trainees tied surgical knots around a 120mm jig using 2/0 glycan polymer. Each trainee tied 11 knots before and after a two and a half hour teaching session. Knots were tested using a mechanical testing machine. OUTCOME MEASURES: Knot strength (N); proportion of knots that were 'secure' (defined as those that eventually failed on the testing device by breakage rather than slippage); proportion of knots that were 'dangerous' (defined as those with a tensile strength of < 5 N). RESULTS: After tuition, the median knot strength of the whole group was 5.7 N stronger than before instruction (95% CI 4.6-12.3 N). Prior to tuition 13.5% (20/148) knots tied had a tensile strength of < 5 N. This was compared with 3.4% (5/148) after tuition (OR = 0.2, 95% CI 0.1-0.6). Before instruction 55.4% (82/148) of the knots were secure compared with 66.9% (99/148) after tuition (OR = 1.6, 95% CI 1.0-2.7). CONCLUSION: Knot tying workshops can improve the ability of trainees in obstetrics and gynaecology to tie reef knots.

Serum CA125 elevation and risk of clinical detection of cancer in asymptomatic postmenopausal women.

BACKGROUND: This study was undertaken to assess the correlation between CA125 elevation, a past history of cancer, and future risk of a diagnosis of cancer among asymptomatic postmenopausal women. METHODS: The subjects consisted of a study group of 771 women with elevated CA125 (> or =30 U/mL) and a control group of 771 women with CA125 <30 U/mL. They were selected from a prospective ovarian carcinoma screening trial of 22,000 postmenopausal women followed for a mean of 2269 days. RESULTS: Subjects in the study group were more likely to have a past history of cancer than subjects in the control group (odds ratio [OR] 2.31, 95% confidence interval [CI] 1.49-3.58). Much of the difference in cancer risk prior to CA125 testing was attributable to a past history of breast carcinoma (OR 2.53, 95% CI 1.45-4.42), but CA125 elevation did not predict recurrence of breast carcinoma. Subjects in the study group were also more likely to develop cancer in the future (OR 2.53, 95% CI 1.61-3.97). This difference was due to an increased risk of gynecologic cancer (OR 30.09, 95% CI 4.09-221.59). CA125 elevation was not associated with an increase in the future risk of developing breast carcinoma (OR 1.19, 95% CI 0.53-2.66) or nongynecologic cancer (OR 1.43, 95% CI 0.86-2.36). CONCLUSIONS: Elevated CA125 in asymptomatic postmenopausal women is not a predictor of nongynecologic cancer or recurrence of cancer, and further investigation should be limited to the detection of gynecologic cancers.