Evaluation of complications, conversion rate, malignancy rate, and, surgeon's experience in laparoscopic assisted supracervical hysterectomy (LASH) of 1274 large uteri: A retrospective study.

INTRODUCTION: Hysterectomy now belongs to standard gynecological procedures. Moreover, a shift towards laparoscopic techniques is ever more apparent as they provide many advantages such as less traumatization and shorter convalescence. Large uteri are still mentioned as contraindications for laparoscopic hysterectomy even though those patients might benefit from the lower morbidity associated with minimal invasive techniques. In this study, the largest reported so far, we analyzed intraoperative and postoperative complications as well as the surgeon's experience of laparoscopic assisted supracervical hysterectomy (LASH) in patients with a uterus weight over 500 g. MATERIAL AND METHODS: The present retrospective study, between June 27, 1998 and August 31, 2019, evaluates 1274 patients with a uterus weight over 500 g who were treated with LASH for benign uterine diseases at the Clinic for Minimal Invasive Surgery (Berlin, Germany). All surgeries were performed by one of four in-house surgeons with experience in LASH: they had performed at least 500 LASH procedures before the study. Patients receiving surgical treatment for malignant tumors were not included in the study. Major and minor intraoperative and postoperative complications were recorded and evaluated. Additionally, medical files were evaluated for demographic data, American Society of Anesthesiologists score (I-IV), name of the surgeon, duration and indication for surgery, history of previous gynecological procedures and concomitant surgical interventions, weight of removed uterine tissue, duration of postoperative hospitalization in patients with complications, intraoperative conversion from laparoscopy to laparotomy, and malignancy rate. RESULTS: The mean age was 47.0 ± 7.3 years and mean body mass index was 25.6 ± 7.1 kg/m2 . Average parity was 1.04 ± 1.57. Average uterus weight was 761.8 ± 317.9 g (500-4065 g). The mean duration of surgery was 96.9 ± 49.5 min; 54% of all patients were treated without concomitant intervention, conversion rate was 2.12%. The malignancy rate was 0.4% and the complication rate was 6.81% with 1.36% intraoperative complications and 5.45% postoperative complications. CONCLUSIONS: The overall low complication and malignancy rates observed in this study allow us to present LASH as a safe and efficient alternative laparoscopic approach to remove uteri of any size in the hands of experienced surgeons.

The Future in Standards of Care for Gynecologic Laparoscopic Surgery to Improve Training and Education.

Standards of care offer doctors and patients the confidence that an established quality, evidence-based, care is provided, and represent a tool for optimal responding to the population's needs. It is expected that they will increasingly express a multimodal relationship with gynecologic laparoscopy. Laparoscopy is, now, a standard procedure in operative gynecology, standards are embedded in many laparoscopic procedures, standardization of the skills/competency assessment has been progressively developed, and the proof of competency in laparoscopy may become a standard of care. A continuous development of surgical education includes standard equipment (that may bring value for future advance), standardized training, testing (and performance) assessment, educational process and outcome monitoring/evaluation, patients' care, and protection, etc. Standards of care and training have a reciprocally sustaining relationship, as training is an essential component of standards of care while care is provided at higher standards after a structured training and as credentialing/certification reunites the two. It is envisaged that through development and implementation, the European wide standards of care in laparoscopic surgery (in close harmonization with personalized medicine) would lead to effective delivery of better clinical services and provide excellent training and education.

Prophylactic Salpingectomy during Hysterectomy for Benign Disease: A Prospective Study to Evaluate High-Grade Serous Ovarian Carcinoma Precursors.

Recent findings suggest that high-grade serous ovarian cancer can originate in the fallopian tube. Not only has that made the identification of precursor lesions pivotal in early detection and prevention of these cancers, prophylactic salpingectomy alongside hysterectomy for benign indications has been increasingly proposed as well. The present prospective single-center study included 273 women who underwent opportunistic salpingectomy alongside laparoscopic supracervical hysterectomy. Uterine and tubal histopathological results as well as intra- and postoperative complications were evaluated. The complication rate was 3.3%, of which none were caused by salpingectomy. Uterine histopathology diagnosed 181 patients (66.8%) with uterine myomas, 60 patients (22.1%) with adenomyosis, 29 patients (10.7%) with adenomyomatosis, and, 1 patient (0.4%) without pathological abnormality. p53 signatures were detected in 221 right fallopian tubes (80.9%) and in 229 left tubes (83.9%). In total, 8 patients showed bilateral STIL (2.9%), whereas in 1 patient (0.4%) STIL was detected in the left tube only. No STIC were detected. Laparoscopic opportunistic salpingectomy is demonstrated to be both safe and feasible. It appears to be promising to reduce the risk for ovarian cancer, yet more studies are needed to undoubtedly confirm this.

Occult Malignancy Rate of 1498 Hysterectomies or Myomectomies with Morcellation: A Retrospective Single-Arm Study.

BACKGROUND AND PURPOSE: Since April 2014, the FDA warns against the use of morcellation during minimally invasive uterine surgery because of the risk of occult malignant spreading in the abdominal cavity. It is clear, however, that more studies are needed to define the incidence of occult uterine cancers, its risk factors, preoperative identification and postoperative follow-up. The present retrospective single-arm study defines the prevalence of occult uterine malignancies in a large group of patients treated with hysterectomy or myomectomy for benign indications. METHODS: In the year of 2014, 1498 women admitted for a myomectomy or hysterectomy in benign conditions at the clinic of minimally invasive surgery (Minimal Invasive Chirurgie or MIC) in Berlin (Germany) were included in this study. The morcellated uterine specimens of operated patients were histologically analyzed for the presence of cancerous tissue. RESULTS: We detected malignancies in three of the 1498 women (0.2%): two patients had endometrial cancer, while we observed cervical cancer in situ in the third patient. No sarcoma was found. CONCLUSION: We detected a very low prevalence of occult uterine malignancy which is in line with several other recent studies. To define a clear policy on the use of morcellation, more studies are required. In the meantime, patients should be informed about the risks of morcellation in case of undetected cancer prior to surgery.

LASH in Severely Enlarged Uterine Leiomyoma: Removal of a Uterus of 4065 g.

Today, even though minimally invasive approaches have become standard worldwide, large uteri are still mainly removed by means of open abdominal approaches. The present case describes the successful removal of the largest uterus ever reported (4065 g) by means of laparoscopy-assisted supracervical hysterectomy (LASH). We combined LASH with the changeover technique which allows a better access and view. We further explain how this approach allows for the safe minimally invasive removal of uteri of any size.

Laparoscopic Ureteral Reimplantation in Endometriosis: A Severe Case.

In aggressive cases, endometriosis can perturb the urogenital tract, in particular the ureter, which can potentially result in ureteral compression or stenosis. Even though this is rare, consequences are dramatic, such as hydronephrosis or organ failure. The present standard intervention comprises the resection of affected tissues and endometriosis foci combined with adjuvant hormonal therapy. When the ureter does not recover, ureteral reimplantation is required. The present case describes the successful laparoscopic approach of the reimplantation of the ureter with simultaneous cystoscopy.

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PURPOSE: Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. METHODS: This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. RESULTS: No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). CONCLUSION: Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

Prevention of intrauterine post-surgical adhesions in hysteroscopy. A systematic review.

OBJECTIVE: The purpose of the present review is to provide a survey of the various measures of preventing adhesions used in hysteroscopic surgery. STUDY DESIGN: A systematic computerized literature search was conducted to provide a survey of the various measures used in hysteroscopic surgery to prevent adhesions. Finally, 29 studies were included in the analysis, showing a wide variety of methods and agents advocated in international literature. They are explained in various sections, based on the IUA prevention approach adopted (surgical technique, early second-look hysteroscopy, barrier method, pharmacological therapy). RESULTS: The results of our review show that (i) use of surgical techniques which reduce the use of electrosurgery should be preferred whenever possible (Level of evidence: 4); (ii) an early second-look hysteroscopy would appear to be an effective preventive, as well as therapeutic, strategy regarding IUA but studies on the topic are too few for relevant evidence; (iii) barriers methods are the most widely used and, among these, gel barriers have been proven to have a significant clinical effect on IUA prevention, because of higher adhesiveness and prolonged residence time on the injured surface (Level of evidence: 1b); (iv) the role of hormonal and antibiotic therapy in the prevention of post-operative IUA is difficult to evaluate as it has been used in association with other prevention strategies in most studies included in our review. CONCLUSIONS: Robust and high quality randomized trials to assess the effectiveness of different anti-adhesion therapies are still needed before one or more of these strategies may be strongly recommended for improving clinical outcomes in women treated by operative hysteroscopy.

Validation of a score to guide endometriosis therapy for the non-specialized gynecologist.

OBJECTIVE: To validate a tool-the ECO system-developed to guide non-specialized gynecologists in the treatment of patients with suspected endometriosis in outpatient clinics. METHODS: In a retrospective study, data were assessed from patients presenting to a center in Brazil or a center in Germany with suspected endometriosis and pelvic pain between July 2012 and June 2013. Data reviewed included patient complaints, clinical extent of disease, patient goals, recent use of medication, previous pelvic surgeries, visual analog pain scale, treatment provided, and histopathology after surgery. Data were transformed into a score according to the ECO system (0-6) indicating the suggested management, which was compared with the approach used in the study hospitals. RESULTS: Among 166 patients, 78 (47.0%) were medically treated and 88 (53.0%) underwent therapeutic laparoscopy. All 3 patients scoring 2 had undergone hormonal treatment. Among 51 patients scoring 3, 49 (96.1%) were clinically managed and 2 (3.9%) underwent surgery. Among 52 patients scoring 4, 26 (50.0%) had undergone medical treatment and 26 (50.0%) surgical treatment. All 56 patients who scored 5 and the four patients who scored 6 underwent surgery. CONCLUSION: The ECO system seems to effectively represent the management of patients with endometriosis in specialized services.

Robotic surgery - advance or gimmick?

Robotic surgery is increasingly implemented as a minimally invasive approach to a variety of gynaecological procedures. The use of conventional laparoscopy by a broad range of surgeons, especially in complex procedures, is hampered by several drawbacks. Robotic surgery was created with the aim of overcoming some of the limitations. Although robotic surgery has many advantages, it is also associated with clear disadvantages. At present, the proof of superiority over access by laparotomy or laparoscopy through large randomised- controlled trials is still lacking. Until results of such trials are present, a firm conclusion about the usefulness of robotic surgery cannot be drawn. Robotic surgery is promising, making the advantages of minimally invasive surgery potentially available to a large number of surgeons and patients in the future.

Laparoscopic sacropexy: a retrospective analysis of perioperative complications and anatomical outcomes.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the surgical outcomes and complications of laparoscopic sacropexy with regard to 3 varying mesh attachment points: the vaginal stump, the cervical stump, and the posterior side of the cervix in the case of uterus preservation. METHOD: A retrospective study was conducted among 310 women treated for descensus with laparoscopic sacropexy between January 2000 and December 2007. Information was obtained from medical files and follow-up examinations. RESULTS: Sacropexies with mesh attachment to the cervical stump, to the vaginal stump, and with uterus preservation were performed in 213, 67, and 30 cases, respectively. In 40 cases, no concomitant interventions were necessary. One perioperative conversion and 2 terminations occurred. Short-term complications included fever in 15 cases and urinary incontinence in 7 cases. Average follow-up was 7.9 mo with 211 patients completing followup. Prolapse recurrence rate was 10.4%; the reoperation rate was 4%. No significant differences between groups were detected for cystocele recurrence. Rectocele recurrence was significantly higher (P < .05) for sacropexy with vaginal mesh attachment. A reduction of incontinence was observed, which was significant (P < .05) for those patients treated with simultaneous or previous hysterectomy. CONCLUSION: Laparoscopic sacropexy shows good short-term results with low reprolapse and complication rates.

DNA damage induced by cis- and carboplatin as indicator for in vitro sensitivity of ovarian carcinoma cells.

BACKGROUND: The DNA damage by platinum cytostatics is thought to be the main cause of their cytotoxicity. Therefore the measurement of the DNA damage induced by cis- and carboplatin should reflect the sensitivity of cancer cells toward the platinum chemotherapeutics. METHODS: DNA damage induced by cis- and carboplatin in primary cells of ovarian carcinomas was determined by the alkaline comet assay. In parallel, the reduction of cell viability was measured by the fluorescein diacetate (FDA) hydrolysis assay. RESULTS: While in the comet assay the isolated cells showed a high degree of DNA damage after a 24 h treatment, cell viability revealed no cytotoxicity after that incubation time. The individual sensitivities to DNA damage of 12 tumour biopsies differed up to a factor of about 3. DNA damage after a one day treatment with cis- or carboplatin correlated well with the cytotoxic effects after a 7 day treatment (r = 0,942 for cisplatin r = 0.971 for carboplatin). In contrast to the platinum compounds the correlation of DNA damage and cytotoxicity induced by adriamycin was low (r = 0,692), or did not exist for gemcitabine. CONCLUSION: The measurement of DNA damage induced by cis- and carboplatin is an accurate method to determine the in vitro chemosensitivity of ovarian cancer cells towards these cytostatics, because of its quickness, sensitivity, and low cell number needed.

Bipolar coagulation with the BiClamp forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal hysterectomy patients.

PURPOSE: To compare bipolar vessel sealing (BVS; BiClamp) versus conventional suture ligation in vaginal hysterectomy. METHODS: A multicenter, single-blind randomized controlled trial (RCT) was conducted at eight women's hospitals in Germany. One hundred and seventy-five patients with benign uterine disease underwent vaginal hysterectomy using BVS (n = 88) or conventional suture ligation (n = 87 controls). Data analysis was based on intention-to-treat. RESULTS: Postoperative pain (primary endpoint) was decreased in the BVS group, but not significantly. Intraoperative blood loss was significantly lower in this group, with <100 mL recorded in 79/88 versus 52/86 patients (P < 0.001). Hemoglobin decrease indicated non-significantly lower blood loss in the BVS group. Operating time was significantly shorter in the BVS group than in the controls (38.0 +/- 18.6 vs. 48.0 +/- 24.9 min; P = 0.001). On average, 7.8 sutures/operation were saved with bipolar coagulation (P < 0.0001). Ease of use ratings were significantly higher for BVS. Hospital stay was similar for both groups. Adverse event rates did not differ significantly. CONCLUSIONS: The BiClamp procedure proved superior or similar to conventional ligation, particularly with regard to intraoperative blood loss, operating time and postoperative pain, although statistical significance was not attained for postoperative pain. Moreover, BVS was easier to use and more cost effective.