Radical vaginal trachelectomy: long-term oncologic and fertility outcomes in patients with early cervical cancer.

OBJECTIVE: Radical vaginal trachelectomy is a fertility-preserving treatment for patients with early cervical cancer. Despite encouraging oncologic and fertility outcomes, large studies on radical vaginal trachelectomy are lacking. METHOD: Demographic, histological, fertility, and follow-up data of consecutive patients who underwent radical vaginal trachelectomy between March 1995 and August 2021 were prospectively recorded and retrospectively analyzed. RESULTS: A total of 471 patients of median age 33 years (range 21-44) were included. 83% (n=390) were nulliparous women. Indications were International Federation of Gynecology and Oncology (FIGO, 2009) stages IA1 with lymphvascular space involvement (LVSI) in 43 (9%) patients, IA1 multifocal in 8 (2%), IA2 in 92 (20%), IB1 in 321 (68%), and IB2/IIA in 7 (1%) patients, respectively. LVSI was detected in 31% (n=146). Lymph node staging was performed in 151 patients (32%) by the sentinel node technique with a median of 7 (range 2-14) lymph nodes and in 320 (68%) by systematic lymphadenectomy with a median of 19 (range 10-59) lymph nodes harvested. Residual tumor was histologically confirmed in 29% (n=136). In total, 270 patients (62%) were seeking pregnancy of which 196 (73%) succeeded. There were 205 live births with a median fetal weight of 2345 g (range 680-4010 g). Pre-term delivery occurred in 94 pregnancies (46%). After a median follow-up of 159 months (range 2-312), recurrences were detected in 16 patients (3.4%) of which 43% occurred later than 5 years after radical vaginal trachelectomy. Ten patients (2.1%) died of disease (five more than 5 years after radical vaginal trachelectomy). Overall survival, disease-free survival, and cancer-specific survival were 97.5%, 96.2%, and 97.9%, respectively. CONCLUSION: Our study confirms oncologic safety of radical vaginal trachelectomy associated with a high chance for childbearing. High rate of pre-term delivery may be due to cervical volume loss. Our long-term oncologic data can serve as a benchmark for future modifications of fertility-sparing surgery.

Oncologic and Fertility Outcomes After Simple Trachelectomy in Women With Early Cervical Cancer.

STUDY OBJECTIVE: This study aimed to present our case series of patients with early-stage cervical cancer undergoing simple trachelectomy (ST). Currently, radical trachelectomy is considered the most appropriate fertility-preserving procedure for the treatment of early-stage cervical cancer. However, there is increasing debate on the appropriate radicality of the surgery to preserve oncologic safety. DESIGN: Descriptive retrospective analysis of patient records and evaluation of questionnaires. SETTING: 2 gynecologic oncologic centers, surgeries performed by one surgical team. PATIENTS: 36 women with early-stage cervical cancer undergoing ST. INTERVENTIONS: Laparoscopic assisted simple vaginal trachelectomy. MEASUREMENTS: Demographic, histologic, fertility, and follow-up data of all patients who underwent ST between April 2007 and July 2021 were prospectively recorded and retrospectively analyzed. MAIN RESULTS: A total of 36 women (mean age: 28 years) underwent ST of whom 81% were nulliparous. Indications for ST were multifocal International Federation of Gynecology and Obstetrics stage IA1 (n = 30), stage IA1 L1 (n = 1), stage IA2 (n = 2), and stage IB1 (n = 3). Mandatory staging procedure was laparoscopic pelvic lymphadenectomy, including bilateral sentinel biopsy in 92% of the cases and systematic in 8%. Residual tumor was histologically confirmed in 8 specimens (22%); 18 women (50%) were seeking parenthood, and 13 succeeded (72%). There were 16 live births, all on term, with a median fetal weight of 3110 grams (2330-4420). One patient had a medical abortion owing to fetal congenital malformation. One pregnancy is ongoing. After a median follow-up of 91.5 months (9-174), all women are alive with no evidence of disease. CONCLUSION: ST represents a de-escalation compared with radical trachelectomy and provides excellent oncologic results with an outstanding fertility rate and obstetric outcome for patients with early cervical cancer. However, clear indications for this tailored fertility-preserving surgery have to be defined in well-designed trials.

Fertility sparing therapy in women with lymph node negative cervical cancer >2cm - oncologic and fertility outcomes of neoadjuvant chemotherapy followed by radical vaginal trachelectomy.

OBJECTIVE: Simple or radical trachelectomy are accepted fertility sparing therapies for patients diagnosed with cervical cancer ≤2 cm. In patients with larger tumors a fertility sparing concept is considered experimental. The aim of our study is to present oncological and fertility outcomes of laparoscopic pelvic lymphadenectomy followed by neoadjuvant chemotherapy and subsequent radical vaginal trachelectomy. These procedures were performed in two centers in patients diagnosed with cervical cancer of diameter >2 cm. METHOD: We retrospectively analyzed the demographic, histological, fertility and follow-up data of all patients with cervical cancer assessed as stage IB2, IB3 or IIA1 under the International Federation of Gynecology and Obstetrics (FIGO) 2018 system. These patients had undergone pelvic lymphadenectomy, followed by neoadjuvant chemotherapy and radical vaginal trachelectomy between February 2006 and June 2020 at Charité University Berlin and Asklepios Hospital, Hamburg. RESULTS: A total of 31 patients (mean age 29.5 years, range; 26-40) underwent neoadjuvant chemotherapy followed by radical vaginal trachelectomy in case of proven tumor-free lymph nodes. Twenty-six (84%) of these patients were nulliparous. Across all 31 patients, the initial tumor stages were FIGO 2018 stage IB2 (n=27), IB3 (n=3) and IIA1 (n=1).Lymphadenectomy was completed in all but one patient (sentinel) with a median of 33 (range; 11-47) pelvic lymph nodes. The neoadjuvant chemotherapy regimen was two cycles of paclitaxel, ifosfamide and cisplatin in 17 patients; three cycles of paclitaxel, ifosfamide and cisplatin in eight patients; two cycles of paclitaxel and cisplatin in four patients; two cylces cisplatin monoagent in one patient; and two cycles of paclitaxel and cisplatin followed by two cycles of paclitaxel, ifosfamide and cisplatin in one patient. Residual tumor was histologically confirmed in 17 specimens (55%). The median residual tumor size following neoadjuvant chemotherapy was 12 mm (range; 1-60). Fertility could be preserved in 27 patients (87%); two patients underwent adjuvant chemoradiation after radical vaginal trachelectomy due to high-risk histological features; two other patients underwent radical hysterectomy with adjuvant chemoradiation therapy following neoadjuvant chemotherapy. Of 18 (67%) patients seeking motherhood, 13 became pregnant (72%). There were 12 live births in 10 women, with a median fetal weight of 2490 grams (range; 1640-3560) and five miscarriages. After a median follow-up of 94.5 months (range; 6-183) three recurrences (11.1%) were detected, one patient (3.7%) died of the disease. CONCLUSION: Neoadjuvant chemotherapy followed by radical vaginal trachelectomy may be offered to patients seeking motherhood with cervical cancer >2 cm and histopathologically tumor-free lymph nodes, the rate of healthy baby pregnancy on discharge was 10/18 women (55%). This fertility-preserving strategy is associated with higher recurrence and death compared with what was published in the literature for women undergoing radical vaginal trachelectomy for tumors up to 2 cm.

Association of preoperative cone biopsy with recurrences after radical hysterectomy.

OBJECTIVE: To evaluate association of preoperative cone biopsy with the probability of recurrent disease after radical hysterectomy for cervical cancer. METHODS: This is a retrospective single-center study. Patients with cervical cancer stage IA1 with LVSI to IIA2 and squamous, adenosquamous and adenocarcinoma subtype were included. Patients were analyzed for general characteristics and recurrence-free survival (RFS). RESULTS: In total, of 480 patients with cervical cancer, 183 patients met the inclusion criteria (117 with laparoscopic and 66 with open surgery). The median tumor diameter was 25.0 mm (range 4.6-70.0 mm) with 66 (36.2%) patients having tumors smaller than 2 cm. During median follow-up of 54.0 months (range 0-166.0 months), the RFS for the laparoscopic cohort was 93.2% and 87.5% at 3 and 4.5 years, and 79.3% for the open cohort after 3 and 4.5 years, respectively. In total, 17 (9.3%) patients developed recurrent disease, 9 (7.3%) after laparoscopic, and 8 (12.1%) after open surgery. No preoperative cone biopsy (OR 9.60, 95% CI 2.14-43.09) as well as tumor diameter > 2 cm (OR 5.39, 95% CI 1.20-24.25) were significantly associated with increased risk for recurrence. In multivariate analysis, only missing preoperative cone biopsy was significantly associated with increased risk for recurrence (OR 5.90, 95% CI 1.11-31.29) CONCLUSION: There appears to be a subgroup of patients (preoperative cone biopsy, tumor diameter < 2 cm) with excellent survival and low risk for recurrence after radical hysterectomy which might benefit from the advantages of laparoscopic surgery.

Abdominal and Laparoscopic Cervical Carcinoma Therapy - a Comparative Economic Assessment.

Objective The LACC (Laparoscopic Approach to Cervical Cancer) study revealed advantages in terms of overall survival and relapse risk favouring abdominal radical hysterectomy over the laparoscopic procedure. The present paper will compare the two surgical techniques from the economic point of view based on a process cost calculation. Material/Methods A retrospective cost analysis of all radical hysterectomies from the year 2018 was done at the Hanover University Medical School based on the bottoms-up method and guided by the clinical treatment pathway. Result Of 51 primary cases treated, 19 patients underwent radical hysterectomies, of which 8 were performed using the abdominal technique and 11 as endoscopic surgeries. 89.4% of the cancers were FIGO IB1 carcinomas. The total cost of a laparoscopic radical hysterectomy with an average hospital stay of 4.6 days came to € 2512.34, compared to an abdominal radical hysterectomy at € 2586.78 with an average hospital stay of 7.6 days. The greatest cost factor in which the laparoscopic method exceeded abdominal radical hysterectomy was the surgical procedure itself (€ 1836.75 vs. € 1411.21). Personnel represented the largest cost item in the surgical theatre (59%), so that surgery time was a significant multiplying factor. Average surgical time required for abdominal radical hysterectomy was 154 minutes, whereby the laparoscopic procedure required an average of 220.1 minutes. Inpatient care in the abdominal radical procedure cases was more costly by € 499.98 due to the longer hospitalization and additional medication required. Profit levels, including the DRG revenues, were higher with the abdominal method than with the laparoscopic method by € 186.21 despite longer hospital stays. Conclusion The present paper shows slightly greater profitability for the abdominal radical hysterectomy. On the other hand, this method entails longer hospitalization and a higher level of personnel deployment. Adequate occupancy management could make up for the revenue shortfall observed with the laparoscopic method.

Surgical versus clinical staging prior to primary chemoradiation in patients with cervical cancer FIGO stages IIB-IVA: oncologic results of a prospective randomized international multicenter (Uterus-11) intergroup study.

OBJECTIVE: Revised staging of patients with locally advanced cervical cancer is based on clinical examination, imaging, and potential surgical findings. A known limitation of imaging techniques is an appreciable rate of understaging. In contrast, surgical staging may provide more accurate information on lymph node involvement. The aim of this prospective study was to evaluate the impact of pre-treatment surgical staging, including removal of bulky lymph nodes, on disease-free survival in patients with locally advanced cervical cancer. METHODS: Uterus-11 was a prospective international multicenter study including patients with locally advanced cervical cancer who were randomized 1:1 to surgical staging (experimental arm) or clinical staging (control arm) followed by primary platinum-based chemoradiation. Patients with histologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIB-IVA underwent gynecologic examination and pre-treatment imaging including abdominal computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI). Patients had chest imaging (any of the following: X-ray, CT, or PET-CT). The primary endpoint was disease-free survival and the secondary endpoint was overall survival. An ad hoc analysis was performed after trial completion for cancer-specific survival. Randomization was conducted from February 2009 to August 2013. RESULTS: A total of 255 patients (surgical arm, n=130; clinical arm, n=125) with locally advanced cervical cancer were randomized. Of these, 240 patients were eligible for analysis. The two groups were comparable with respect to patient characteristics. The surgical approach was transperitoneal laparoscopy in most patients (96.6%). Laparoscopic staging led to upstaging in 39 of 120 (33%) patients. After a median follow-up of 90 months (range 1-123) in both arms, there was no difference in disease-free survival between the groups (p=0.084). For patients with FIGO stage IIB, surgical staging is superior to clinical staging with respect to disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011). In the post-hoc analysis, surgical staging was associated with better cancer-specific survival (HR 0.61, 95% CI 0.40 to 0.93, p=0.020). CONCLUSION: Our study did not show a difference in disease-free survival between surgical and clinical staging in patients with locally advanced cervical cancer. There was a significant benefit in disease-free survival for patients with FIGO stage IIB and, in a post-hoc analysis, a cancer-specific survival benefit in favor of laparoscopic staging. The high risk of distant metastases in both arms emphasizes the need for further evaluation.

Sentinel lymph node biopsy in vulvar cancer: status, level of knowledge, and counseling in outpatient setting.

PURPOSE: Evaluating the counseling of patients with vulvar cancer in outpatient setting regarding the application of sentinel lymph node dissection (SLND), the selection of hospitals for further treatment, and level of knowledge. METHODS: A questionnaire containing 29 questions about SLND in vulvar cancer was sent to gynecologists in Lower Saxony. The questionnaire contained multiple choice questions and open questions. The study was approved by the local ethics committee. RESULTS: The median age of the 86 respondents was 54 (26-66) years. Most participants (83.1%) reported to only treat one to five patients with vulvar cancer per year. Interestingly, 70.5% of the gynecologists send their patients to university hospitals and 64.1% to hospitals offering maximum care, respectively. Of all, 32.7% replied that SLND was performed rarely or never in their patients. The gynecologists answered that only 36.7% of the patients are well informed about advantages and possible disadvantages of SLND. Most (84%) felt responsible to counsel patients on treatment decisions independently from or additionally to the hospital. Of all, 72% replied that they are not completely sure about the exact recurrence rates after SLND. Of notice, 66% believe that SLND for vulvar cancer is safe if applied in specialized centers and 92% stated that focusing treatment on specialized centers is required for best results. CONCLUSION: SLND for vulvar cancer is widely accepted and regularly recommended among gynecologists. Outpatient doctors report to send most patients to specialized centers. However, it appears that patients remain uninformed after counseling in the clinics and that there is a lack of detailed knowledge about risks and complication rates of groin treatment in the outpatient setting.

Radical hysterectomy for early cervical cancer: what shall we do after the LACC trial?

Surgical treatment of cervical cancer has led to one of the greatest controversies in gynecological oncology in recent years. After laparoscopic radical hysterectomy became increasingly widespread worldwide, it lost its importance dramatically when the data from the LACC study were published. In contrast to previous assumptions, there was a significantly reduced survival after laparoscopic hysterectomy compared to the open abdominal procedure. Multiple studies were subsequently published. Some confirm these results some do not. Some consider further studies to be unethical, others point to their own non-randomized results and call for a new LACC study. This article gives an overview of the current data situation and the possible criticisms of the individual studies. And, finally, calls for new RCT's under defined criteria.

Peritoneal contamination with ICG-stained cervical secretion as surrogate for potential cervical cancer tumor cell dissemination: A proof-of-principle study for laparoscopic hysterectomy.

INTRODUCTION: Intracorporal colpotomy during radical hysterectomy for cervical cancer is discussed to be a risk factor for peritoneal dissemination of tumor cells. It might lead to increased recurrence rates after laparoscopic radical hysterectomy compared with abdominal hysterectomy, as shown by the recent LACC study. Data on the frequency or mechanisms of peritoneal contamination are missing. We aimed to analyze peritoneal contamination of cervical secretion during intracorporal colpotomy with a novel indocyaningreen (ICG)-based technique. MATERIAL AND METHODS: In this prospective proof-of-principle study, patients undergoing routine laparoscopic or robot-assisted hysterectomy were selected. ICG was specifically applied to the cervical surface and routine surgery was performed. During colpotomy, pictures under white and fluorescence light were taken to evaluate frequency of contamination. RESULTS: By using cervically applied ICG we were able to visualize directly peritoneal contamination with cervical secretion during intracorporal colpotomy. We detected peritoneal contamination in 9/12 (75%) patients undergoing routine laparoscopic hysterectomy. Contamination of laparoscopic instruments occurred in 60% of the patients. When contamination occurred, it was routinely detectable during all steps of colpotomy. There were no adverse effects during surgery. CONCLUSIONS: Peritoneal contamination with cervical secretion frequently occurs during intracorporal colpotomy. This novel technique represents a promising tool for feasible and direct visualization of peritoneal contamination during colpotomy. The technique may be easily implemented in further studies on laparoscopic and abdominal hysterectomy and serve as a quality assessment tool for surgeons and surgical techniques.

Laparoscopic radical hysterectomy with transvaginal closure of vaginal cuff - a multicenter analysis.

OBJECTIVE: Laparoscopic/robotic radical hysterectomy has been historically considered oncologically equivalent to open radical hysterectomy for patients with early cervical cancer. However, a recent prospective randomized trial (Laparoscopic Approach to Cervical Cancer, LACC) has demonstrated significant inferiority of the minimally invasive approach. The aim of this study is to evaluate the oncologic outcomes of combined laparoscopic-vaginal radical hysterectomy. METHODS: Between August 1994 and December 2018, patients with invasive cervical cancer were treated using minimally-invasive surgery at the Universities of Jena, Charité Berlin (Campus CCM and CBF) and Cologne and Asklepios Clinic Hamburg. 389 patients with inclusion criteria identical to the LACC trial were identified. In contrast to the laparoscopic/robotic technique used in the LACC trial, all patients in our cohort underwent a combined transvaginal-laparoscopic approach without the use of any uterine manipulator. RESULTS: A total of 1952 consecutive patients with cervical cancer were included in the analysis. Initial International Federation of Gynecology and Obstetrics (FIGO) stage was IA1 lymphovascular space invasion (LVSI+), IA2 and IB1/IIA1 in 32 (8%), 43 (11%), and 314 (81%) patients, respectively, and histology was squamous cell in 263 (68%), adenocarcinoma in 117 (30%), and adenosquamous in 9 (2%) patients. Lymphovascular invasion was confirmed in 106 (27%) patients. The median number of lymph nodes was 24 (range 2-86). Lymph nodes were tumor-free in 379 (97%) patients. Following radical hysterectomy, 71 (18%) patients underwent adjuvant chemoradiation or radiation. After a median follow-up of 99 (range 1-288) months, the 3-, 4.5-, and 10-year disease-free survival rates were 96.8%, 95.8%, and 93.1 %, and the 3-, 4.5-, and 10-year overall survival rates were 98.5%, 97.8%, and 95.8%, respectively. Recurrence location was loco-regional in 50% of cases with recurrence (n=10). Interestingly, 9/20 recurrences occurred more than 39 months after surgery. CONCLUSION: The combined laparoscopic-vaginal technique for radical hysterectomy with avoidance of spillage and manipulation of tumor cells provides excellent oncologic outcome for patients with early cervical cancer. Our retrospective data suggest that laparoscopic-vaginal surgery may be oncologically safe and should be validated in further randomized trials.

Sentinel lymphadenectomy in cervical cancer using near infrared fluorescence from indocyanine green combined with technetium-99m-nanocolloid.

OBJECTIVE: Sentinel diagnostic in cervical cancer is performed using Technetium-99m-nanocolloid as a radioactive marker with or without patent blue. In the last years, indocyanine green has been evaluated for sentinel diagnostic in different tumor entities. Indocyanine green is a fluorescent molecule which emits a light signal in the near infrared band after excitation. Our study aims to evaluate indocyanine green compared to the gold standard Tc-99m-nanocolloid. MATERIALS AND METHODS: We included patients with early cervical cancer up to FIGO stage IIA with clinically node-negative pelvic sites and the indication for nodal staging in this prospective trial. Sentinel diagnostic was carried out using Tc-99m-nanocolloid, indocyanine green and patent blue. We examined each pelvic site for light signals from the near infrared band, for radioactivity and for blue staining. A sentinel lymph node was defined as a Tc-99m-nanocolloid positive lymph node. All sentinel lymph nodes and all additional blue or fluorescent lymph nodes were excised and tested; then sent to histologic examination. RESULTS: Thirty-three patients were included in which we found 211 Tc-99m-nanocolloid-positive sentinel lymph nodes in 66 pelvic sites. Two hundred and seven of these lymph nodes were positive for indocyanine green, too, giving a sensitivity of 98.1% (95%CI 94.9-99.4%) compared to Tc-99m-nanocolloid. One hundred and sixty additional lymph nodes showed indocyanine green fluorescence but no Tc-99m-positivity, so that the sensitivity was 79.6% (95%CI 76.6-82.3%). In one patient, a pelvic site was only identified to be tumor infiltrated due to an ICG-positive, but Tc-99m-negative lymph node. CONCLUSION: Our results show that indocyanine green is a promising approach for pelvic sentinel identification in cervical cancer. ICG has a similar sensitivity as radioactive Tc-99m-nanocolloid and may enhance both patient safety and surgeons' comfort. Lasers Surg. Med. 50:994-1001, 2018. © 2018 Wiley Periodicals, Inc.

Peri- and postoperative management and outcomes of morbidly obese patients (BMI > 40 kg/m2) with gynaecological disease.

INTRODUCTION: For the last two decades, obesity rates have been increasing in both developed and developing countries, with the number of obese women roughly doubling during this period (Stevens et al. in Popul Health Metr 10(1):33, 2012). Obesity represents one of the biggest epidemics of the 21st century. The aim of this retrospective study is to characterise the outcomes of gynaecologic surgeries in cases of extremely obese women with a body mass index (BMI) over 40 kg/m2. METHODS: This study is a retrospective case control study in a single-centre setting. Our clinical database was searched for gynaecological operations performed on morbidly obese patients (BMI > 40 kg/m2) between 2009 and 2014 in the Department of Gynaecology and Obstetrics at Hannover Medical School. We matched these results with random patients of normal body weight who had similar surgical procedures and diseases. RESULTS: We included 97 obese patients in our case group and 99 patients in the control group. We found an association between a strongly elevated BMI and peri- and postoperative morbidity. Both intraoperative and postoperative complications are significantly increased in morbid obesity with a BMI over > 40 kg/m2. We observed intraoperative complications in 55.6% and postoperative complications in 50.5% of patients with extreme obesity. In contrast, the complication rate in the control group with a normal BMI was 11% intraoperatively (p = 0.0001) and 3% postoperatively (p = 0.0001). The data showed that perioperative and postoperative morbidity could be reduced by laparoscopic surgery in many cases, with a significant lower rate of difficulties with closing the wound, a significant shorter duration of surgery and a significant lower rate of infections combined with a significant lower reoperation rate and shorter hospital stay. In gynaecological-oncological diseases, we could demonstrate a reduced radicality during the operative procedure due to extreme obesity. DISCUSSION: Dealing with the growing number of obese patients is essential, because the problems emerging from obesity are manifold for the treating hospitals as well as the general health system. For this high-risk patient group, it is indispensable to obtain a thorough overview of the patient's overall situation preoperatively to ensure good perioperative care and complications management.

Sarcoma Risk in Uterine Surgery in a Tertiary University Hospital in Germany.

OBJECTIVES: There is a risk to incidentally spread uterine malignancies, especially sarcoma, if tissue is morcellated during hysterectomy or myoma enucleation. In the last years, a worldwide discussion has been started about this problem. However, the risk seems to be very small in recent studies. This study aims at further investigating the risk of disseminating uterine malignancy during uterine surgery in a tertiary university hospital in Germany. METHODS: In a retrospective setting, all cases of uterine myometrial surgery (hysterectomies and myomectomies) in our clinic during a period of 10 years were identified using clinical databases. Histology was linked and searched for uterine malignancies. All cases were reviewed for incidental morcellation of malignant tissue. RESULTS: Between 2004 and 2014, we identified 2825 cases of uterine myometrial surgery. Morcellating procedures were used in 20% of the 1402 hysterectomy procedures (280/1402) and in 13.7% of the 1423 fibroid removals (195/1423). We identified 23 uterine mesenchymal malignancies (sarcoma, n = 10; carcinosarcoma, n = 13). In 3 cases, there was no evidence or sign of a malignant disease preoperatively in a procedure with a morcellation (vaginal hysterectomy with morcellation, n = 1; open fibroid enucleation, n = 2). CONCLUSIONS: A small risk (0.35% [1/280]) of accidental morcellation during hysterectomy with morcellation was found in our study. We did not observe an occult case of sarcoma after myomectomy with morcellation (0/195), but we found 2 cases of accidental sarcoma after myomectomy without morcellation. For these reasons, minimally invasive surgery with morcellation should not be excluded a priori. The patient should be well informed about the risks and various options. The advantage of laparoscopic surgery should be balanced against the risk of the unknown spread of malignant tissue.

Sentinel Lymphadenectomy in Vulvar Cancer Using Near-Infrared Fluorescence From Indocyanine Green Compared With Technetium 99m Nanocolloid.

OBJECTIVE: Nowadays, sentinel diagnostic is performed using technetium 99m (Tc) nanocolloid as a radioactive marker and sometimes patent blue. In the last years, indocyanine green has been evaluated for sentinel diagnostic in different tumor entities. Indocyanine green is a fluorescent molecule that emits a light signal in the near-infrared band after excitation. Our study aimed to evaluate indocyanine green compared with the criterion-standard Tc-nanocolloid. METHODS: We included patients with primary, unifocal vulvar cancer of less than 4 cm with clinically node-negative groins in this prospective trial. Sentinel diagnostic was carried out using Tc-nanocolloid, indocyanine green, and patent blue. We examined each groin for light signals from the near-infrared band, for radioactivity, and for blue staining. A sentinel lymph node was defined as a Tc-nanocolloid-positive lymph node. All sentinel lymph nodes and all additional blue or fluorescent lymph nodes were excised and tested and then sent for histologic examination. RESULTS: In all, 27 patients were included in whom we found 91 sentinel lymph nodes in 52 groins. All these lymph nodes were positive for indocyanine green, also giving a sensitivity of 100% (95% confidence interval [CI], 96.0%-100%) compared with Tc-nanocolloid. Eight additional lymph nodes showed indocyanine green fluorescence but no Tc positivity, so that the positive predictive value was 91.9% (95% confidence interval, 84.6%-96.5%). In 1 patient, a false-negative sentinel missed by all 3 modalities was found. CONCLUSIONS: Our results show that indocyanine green is a promising approach for inguinal sentinel identification in vulvar cancer with a similar sensitivity as radioactive Tc-nanocolloid and worth to be evaluated in further studies.

Association between intraabdominal pressure during gynaecologic laparoscopy and postoperative pain.

PURPOSE: Laparoscopy is nowadays a well-established surgical method and plays a main role in an ever-increasing range of indications in gynaecology. High-quality studies of surgical techniques are necessary to improve the quality of patient care. The present study aims at evaluating postoperative pain after gynaecological laparoscopy depending on the intraoperative CO2 pressure. METHODS: In a prospective, monocentric, randomized single-blind study at the Department of Gynaecology and Obstetrics at the Hannover Medical School, we include patients scheduled for different laparoscopic procedures. Randomization of the intraoperative CO2 pressure was carried out in six groups. Pain was assessed the day after surgery by the blinded nurse using a visual analogue scale. RESULTS: 550 patients were included in the period from May 2013 to January 2016. The analysis of the per protocol population PPP (n = 360) showed no statistically significant difference between the six intervention groups with regard to mean postoperative pain perception. In direct comparison between two groups, an intraoperative CO2 pressure of 15 mmHg was associated with a significant higher pain score than a pressure of 12 mmHg. The difference was 7.46 mm on a 10 cm VAS. CONCLUSIONS: The results of our study indicate that a CO2 pressure of 12 versus 15 mmHg can be advantageous. However, the clinical relevance remains unclear due to the low difference in pain. The additional benefit of an even lower pressure of 10 or 8 mmHg cannot be reliably assessed; we found signs of poor visibility conditions in these low pressure groups.

Postoperative anatomic and quality-of-life outcomes after vaginal sacrocolporectopexy for vaginal vault prolapse.

OBJECTIVE: To assess anatomic outcome and quality of life (QOL) after vaginal sacrocolporectopexy among patients with pelvic organ prolapse. METHODS: A noncomparative observational study was conducted at Hanover Medical School, Germany, among patients who underwent vaginal sacrocolporectopexy for uterine or vaginal vault prolapse between May 1, 2006, and October 31, 2012. A validated German version of the Prolapse QOL (P-QOL) questionnaire was sent to eligible patients; respondents were invited for follow-up examination. RESULTS: Overall, 128 patients were enrolled. Concomitant hysterectomy was performed among 82 (64.1%) patients, anterior colporrhaphy among 105 (82.0%), and posterior colporrhaphy among 58 (45.3%). After a mean interval of 26.5 months (range 1.0-81.3 months), seven patients exhibited recurrent vaginal vault prolapse of at least stage 2, giving a success rate of 92.3% (95% confidence interval 85.9%-96.5%). The P-QOL scores were either low (<40) or very low (<20), indicating high QOL. Regarding symptoms related to pelvic organ prolapse, patients reported little or no impact on QOL after vaginal sacrocolporectopexy. CONCLUSION: Vaginal sacrocolporectopexy seemed safe and feasible, leading to anatomically correct fixation of the vaginal apex, high anatomic success rates, and good QOL. This procedure might be considered as an alternative to laparoscopic or abdominal sacrocolpopexy.

Groin Recurrences in Node Negative Vulvar Cancer Patients After Sole Sentinel Lymph Node Dissection.

OBJECTIVE: This study aimed to evaluate the recurrence rates after sole sentinel dissection in vulvar cancer and describe characteristics of groin recurrences. METHODS: All vulvar cancer cases between 2008 and 2014 were reviewed. Inclusion criteria were restricted to lymph node-negative patients, sole sentinel lymph node dissection (SLND), and tumor diameter less than 4 cm. In all patients, Tc-99m nanocolloid was used for preoperative SLN imaging. Regularly, planar lymphoscintigraphy and single-photon emission computed tomography with computed tomography were performed. Ultrastaging was routinely conducted on all negative lymph nodes. RESULTS: Of 140 vulvar cancer cases, 30 node-negative patients underwent sole SLND and met inclusion criteria. Keratinizing squamous cell carcinoma was determined in final histology in 20/30 (66.7%) patients and the mainly diagnosed tumor stage was pT1b (21/30, 70%). Three perioperative complications occurred. On average, 4.6 (1-9) SLNs were dissected per patient and 2.5 (1-6) per each groin, respectively. During a median follow-up of 43.5 (4-75) months, 5/30 (16.7%; 95% confidence interval, 7.3%-33.6%) local recurrences occurred. In addition, 2/30 (6.6%; 95% confidence interval, 1.9%-21.3%) groin recurrences were identified within a period of 12 months after the primary surgery. Both patients had large (>2 cm) midline tumors. Despite surgical as well as adjuvant treatment of the recurrent disease, both patients with groin recurrences died. CONCLUSIONS: Sentinel lymph node dissection is a safe and feasible alternative in early vulvar cancer. But false-negative sentinel carry a high risk of mostly fatal groin recurrences. Especially, midline tumors larger than 2 cm have to be treated with caution, because they are mostly found in cases with groin recurrences after sole SLND.

Application of sentinel lymph node dissection in gynecological cancers: results of a survey among German hospitals.

PURPOSE: Evaluating the application of the sentinel lymph node dissection (SLND) in gynecological cancers among German hospitals. METHODS: Between March and June 2016 an online questionnaire on SLND in gynecologic cancers was sent by email to all German gynecologic cancer centers, all university hospitals and general hospitals for which an email address was available. The survey contained 61 questions regarding the SLND in vulvar, cervical, endometrial and ovarian cancer. RESULTS: In total, 63 clinics, including 13 (20.6%) university hospitals, 28 (44.4%) hospitals offering maximum care and 22 (34.9%) general hospitals, responded to the questionnaire. Most clinics (46/63, 73%) performed SLND in vulvar cancer with a median amount of 7.8 (range 1-43) SLND per year. 56.5% of the clinics included patients according to the German national guidelines and performed ultrastaging of negative SLN. Furthermore, 18/63 (28.5%) of the responding clinics applied SLND in cervical cancer including 7 (77.8%) centers which conducted isolated SLND without radical pelvic lymph node dissection (LND). Preoperative imaging with planar lymphoscintigraphy (LSG) was applied in 12/18 (66.7%) of the clinics. SLND in endometrial cancer was reported by 4/63 (6.4%) hospitals. Three of them (75%) regularly performed a subsequent radical pelvic LND. One clinic (1.5%) reported SLND in ovarian cancer in combination with radical LND. CONCLUSION: Especially in vulvar and cervical cancer, isolated SLND appears to be partially implemented in the routine surgical treatment. However, this survey illustrates a wide heterogeneity regarding inclusion criteria and application of the SLND approach.

Epidemiology and Early Detection of Cervical Cancer.

The new German S3 guideline 'Prevention of Cervical Cancer' published in 2016 is based on the latest available evidence about cervical cancer screening and treatment of cervical precancer. Large randomized controlled trials indicate that human papillomavirus (HPV)-based screening may provide better protection against cervical cancer than cytology alone through improved detection of premalignant disease in the first screening round prior to progression. Therefore, women aged 30 years and older should preferably be screened with HPV testing every 3-5 years (cytology alone every 2 years is an acceptable alternative). Co-testing is not recommended. Screening should start at 25 years using cytology alone every 2 years. The preferred triage test after a positive HPV screening test is cytology. Women positive for HPV 16 and HPV 18 should receive immediate colposcopy. Another alternative triage method is p16/Ki-67 dual stain cytology. The mean yearly participation rate in Germany is between 45 and 50%. Offering devices for HPV self-sampling has the potential to increase participation rates in those women who are at higher risk of developing cervical cancer. Regarding primary prevention, the 9-valent vaccine may provide protection against up to 85% of cervical intraepithelial neoplasia (CIN) 3 and 90% of cervical cancer, and is available in Europe as a 2-dose schedule from May 2016.

Radiofrequency endometrial ablation for the treatment of heavy menstrual bleeding among women at high surgical risk.

OBJECTIVE: To evaluate quality of life (QoL) after radiofrequency endometrial ablation (RFEA) for heavy menstrual bleeding among women at high surgical risk. METHODS: An observational study was undertaken among women aged at least 18 years who underwent RFEA at Hanover Medical School, Germany, between June 2010 and November 2012. A validated menorrhagia outcomes questionnaire (MOQ) was used to evaluate QoL and global outcomes among patients at high risk and low risk of complications after major surgery. The high-risk group included women with anemia, coagulopathy, anticoagulation, thromboembolism, transplantation, malignancy, severe cardiovascular or pulmonary disease, and obesity. RESULTS: Overall, 235 women underwent RFEA during the study period. Median follow-up was 13 months (range 3-30). Questionnaire responses were received from 202 (86.0%) women, including 132 (65.3%) high-risk patients. The MOQ total outcome (mean difference 2.0; P = 0.166) and QoL/satisfaction (mean difference 0.8; P = 0.601) scores were similar in the two groups. Success (i.e. symptom relief and no further surgery) was recorded for 119 (90.2%) patients in the high-risk group and 67 (95.7%) patients in the low-risk group (P = 0.155). CONCLUSION: RFEA improved QoL and achieved a high rate of satisfaction for both high- and low-risk patients. RFEA offers a less invasive alternative to hysterectomy and its associated perioperative risks, particularly among high-risk patients.