Somatic genomic landscape of East Asian epithelial ovarian carcinoma and its clinical implications from prospective clinical sequencing: A Korean Gynecologic Oncology Group study (KGOG 3047).

Through the wide adaptation of next-generation sequencing (NGS) technology within clinical practice, molecular profiling of the tumor has been the principal component of personalized treatment. In our study, we have generated a large collection of cancer genomes on East Asian epithelial ovarian carcinoma (EOC) patients and demonstrate the feasibility and utility of NGS platforms to explore the dynamic interrelations of major cancer driver alterations and their impacts on clinical prognosis and management. A total of 652 EOC patients have undergone clinical NGS panels to determine the prevalence of germline and somatic mutations. Notably, TP53 was the most frequently altered event (73%), followed by both BRCA1 and BRCA2 (22% each) and MYC (19%) through pan-EOC analysis. When analyzed based on individual histopathological levels, TP53 mutation was highly dominant in high-grade serous and mucinous histology, whereas mutations in PIK3CA and ARID1A were mostly observed in clear cell carcinoma, and KRAS, BRAF, and CDKN2A mutations were enriched in endometrioid, low-grade serous, and mucinous tumors, respectively. The network-based probabilistic model showed significant co-occurrences of TP53 with BRCA1 and ALK with BRCA2, NOTCH1, and ROS1, whereas mutual exclusivity of TP53 with KRAS and PIK3CA was evident. Furthermore, we utilized machine-learning algorithms to identify molecular correlates that conferred increased sensitivity to platinum and olaparib treatments including somatic mutations in BRCA1, ATM, and MYC. Conversely, patients with ALK mutation were considerably resistant to both treatment modalities. Collectively, our results demonstrate the clinical feasibility of prospective genetic sequencing to facilitate personalized treatment opportunities for patients with EOC.

Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol.

BACKGROUND: The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer. METHODS: This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%. DISCUSSION: We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery. TRIAL REGISTRATION: ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020.

Comparison of surgical outcomes between 3-dimensional and 2-dimensional laparoscopy of ovarian cyst (LOOC): a randomised controlled trial.

The purpose of this study was to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems for the treatment of ovarian cyst. A total of 46 patients undergoing a laparoscopic ovarian cystectomy were randomly assigned to either the 3D or 2D laparoscopy group. The primary outcome measure was the operative blood loss. The secondary outcome measure was visually induced motion sickness (VIMS), task efficacy during laparoscopy, and postoperative complication. There were no differences in baseline demographics between the two groups. The operative blood loss was significantly smaller in the 3D groups (28.7 ± 11.6 mL) than in the 2D groups (46.5 ± 24.4 mL) (p = .012). VIMS score was significantly higher in the 3D groups than the 2D groups (p < .001). 3D laparoscopy was superior to 2D in terms of the task efficacy of ovarian cyst enucleation (p < .001), adhesiolysis or dissection (p < .001), and ovarian suturing (p = .008). None of the patients in both groups developed operative complications. In conclusion, a 3D imaging system showed a more favourable surgical outcome and improved task efficacy than 2D in laparoscopic ovarian cystectomy. However, 3D laparoscopy tends to cause more frequent VIMS in surgeons.Impact statementWhat is already known on this subject? Several studies examining the possible benefits and drawbacks of a 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. However, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic ovarian cystectomy.What do the results of this study add? 3D laparoscopy showed favourable surgical outcomes and improved task efficacy than 2D laparoscopy in ovarian cystectomy.What are the implications of these findings for clinical practice and/or further research? More complex procedures, such as suturing and adhesiolysis, might be easier to perform with 3D laparoscopy than with 2D laparoscopy. Therefore, further large studies of 3D gynaecologic laparoscopy with different complexities and for surgeons with different surgical skills are needed.

Postoperative analgesic efficacy of continuous wound infusion with local anesthetics after laparoscopy (PAIN): a randomized, double-blind, placebo-controlled trial.

BACKGROUND: To investigate the efficacy of continuous wound infusion (CWI) with local anesthetics for reducing postoperative pain compared with placebo in patients undergoing benign gynecologic laparoscopy. METHODS: In this double-blind trial, 66 patients were randomly assigned to receive either ropivacaine or normal saline though a multi-orifice catheter placed into the umbilical surgical wound for 50 h postoperatively. The primary outcome measure was the severity of postoperative pain 1, 6, 12, 24, and 48 h after surgery. The secondary outcome measure was the number of rescue analgesics requested. RESULTS: Baseline characteristics did not statistically differ between the ropivacaine and placebo groups. The intensity of postoperative pain was significantly lower in the ropivacaine group than in the placebo group 1, 6, 12, 24, and 48 h after surgery (all P < 0.05). The number of rescue analgesics requested was also significantly lower in the ropivacaine group than in the placebo group. There were no significant differences between the two groups regarding other surgical outcomes. CONCLUSION: CWI with local anesthetics after laparoscopic surgery provides good analgesia and reduces rescue analgesics consumption.

Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study.

BACKGROUND: Tools for the evaluation of gastric emptying have evolved over time. The purpose of this study was to show that the risk of pulmonary aspiration is not increased with carbohydrate drink, by demonstrating that the gastric antral cross-sectional area (CSA) of the NO-NPO group is either equivalent to or less than that of the NPO (nil per os) group. METHODS: Sixty-four patients scheduled for elective laparoscopic benign gynecologic surgery were enrolled and randomly assigned to the NPO group (n = 32) or the NO-NPO group (n = 32). After having a regular meal until midnight before surgery, the NPO group fasted until surgery, while the NO-NPO group ingested 400 mL of a carbohydrate drink at midnight and freely up to 2 hours before anesthesia. The primary outcome was the gastric antral CSA by gastric ultrasound in right lateral decubitus position (RLDP). Noninferiority was defined as a mean difference of CSA <2.8 cm2. Secondary outcomes included CSA in supine position, gastric volume (GV), GV per weight (GV/kg), GV/kg >1.5 mL/kg, and Perlas grade. RESULTS: CSA in RLDP was not different between the NPO group (6.25 ± 3.79 cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P = .959). The mean difference of CSA in RLDP (NO-NPO group - NPO group) was 0.04 (95% confidence interval [CI], -1.56 to 1.64), which was within the noninferiority margin of 2.8 cm2. CSA was not different between the 2 groups (4.17 ± 2.34 cm2 in NPO group versus 4.28 ± 1.23 cm2 in NO-NPO group; P = .828). GV in NPO group (70 ± 56 mL) was not different from NO-NPO group (66 ± 36 mL; mean difference, 3.66; 95% CI, -20 to 27; P = .756). GV/kg in the NPO group (1.25 ± 1.00 mL/kg) was not different from the NO-NPO group (1.17 ± 0.67 mL/kg; P = .694). The incidence of GV/kg > 1.5 mL/kg was not different between NPO (31.3%) and NO-NPO group (21.9%; P = .768). The median (interquartile range) of the Perlas grade was 1 (0-1) in NPO group and 0.5 (0-1) in NO-NPO group (P = .871). CONCLUSIONS: Preoperative carbohydrates ingested up to 2 hours before anesthesia do not delay gastric emptying compared to midnight fasting, as evaluated with gastric ultrasound.

Preoperative Oral Carbohydrate Loading in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial.

STUDY OBJECTIVE: To determine whether carbohydrate loading improves the postoperative quality of recovery (QoR) better than the midnight fasting policy in laparoscopic gynecologic surgeries. DESIGN: Randomized, parallel-group trial. SETTING: Tertiary university hospital. PATIENTS: Female patients scheduled for laparoscopic gynecologic surgery for nonmalignant gynecologic diseases. INTERVENTIONS: Eighty-eight women were randomly assigned to the midnight fasting group (nil per os, NPO group) or the carbohydrate loading group (carbohydrate group). Patients in both groups adhered to the enhanced recovery after surgery protocol except for carbohydrate intake in the carbohydrate group. MEASUREMENTS AND MAIN RESULTS: The postoperative QoR was evaluated using the QoR 15-item questionnaire on postoperative day 2. The times to readiness for discharge of the groups were compared. The QoR 15-item questionnaire scores were 97.7 ± 23.0 in the NPO group and 99.6 ± 22.4 in the carbohydrate group; they were not statistically different (p = .702). The times to readiness for discharge of both groups were also not different: 36.8 ± 12.2 hours in the NPO group and 37.6 ± 11.8 hours in the carbohydrate group (p = .684). CONCLUSION: The benefit of carbohydrate beverage intake was not significant in laparoscopic gynecologic surgeries when following the enhanced recovery after surgery protocol.

Leak-proof technique in laparoscopic surgery for large ovarian cysts.

The aim of this study was to compare the spillage rate and surgical outcomes between the leak-proof technique and the conventional technique in laparoscopy for large ovarian cysts (more than 15 cm in diameter) presumed to be benign tumours and free from adhesion. Thirty-five consecutive patients who underwent laparoscopy with the leak-proof technique between 2017 and 2019 (the practice change cohort) were compared retrospectively with 35 case-matched consecutive patients who underwent the conventional purse-string method between 2014 and 2016 (the historical cohort). In the practice change cohort, through the wound retractor in the umbilicus, large ovarian cysts were first covered with a sterilised vinyl membrane applied with a skin adhesive, then punctured, and the contents directly aspirated. The primary outcome was tumour spillage. The two cohorts had similar baseline characteristics. The spillage rate in the practice change cohort was significantly lower than in the historical cohort (0% vs 28.6%; p = .001). Other surgical outcomes, including operative time, operative blood loss, hospital stay, and operative complications were similar between the cohorts. In conclusion, laparoscopy with the leak-proof technique is reliable, safe, and easily implemented in the management of selected patients with large ovarian tumours and low probability of malignancy.IMPACT STATEMENTWhat is already known on this subject: Large ovarian cysts preclude the laparoscopic surgery because the size of the cyst interferes with adequate visualisation of the pelvic anatomy and confines the mobilisation of laparoscopic devices.What do the results of this study add: Laparoscopy with the leak-proof technique is reliable, safe, and easily implemented in the management of selected patients with large ovarian tumours and low probability of malignancy.What are the implications of these findings for clinical practice and/or further research: This technique is easily implemented and useful for most gynaecologic surgeons in treating extremely large ovarian cysts.

Reduction of cycles of neoadjuvant chemotherapy for advanced epithelial ovarian, fallopian or primary peritoneal cancer (ROCOCO): study protocol for a phase III randomized controlled trial.

BACKGROUND: Primary debulking surgery (PDS) and adjuvant chemotherapy is the standard treatment for advanced ovarian, fallopian or primary peritoneal cancer. However, neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) has been introduced as an alternative, showing similar efficacy and decreased postoperative complications compared with PDS. Although there is still no evidence for whether three or four cycles of NAC used clinically could be adequate, reducing one cycle of NAC is expected to remove more visible tumours and thereby improve prognosis. Thus, we proposed with this study to evaluate the efficacy and safety of reducing one cycle of NAC for advanced ovarian, fallopian or primary peritoneal cancer. METHODS: This study is a prospective, multi-centre, open-label, randomized phase III trial. A total of 298 patients with advanced ovarian, fallopian or primary peritoneal cancer will be recruited and randomly assigned to either three (control group) or two cycles of NAC (experimental group). After the NAC, we will conduct IDS with maximal cytoreduction and then administer the remaining three or four cycles for a total of six cycles of adjuvant chemotherapy. The primary end point is progression-free survival, and the secondary end points are time to tumour progression, overall survival, tumour response after NAC, IDS and adjuvant chemotherapy, radiologic investigation after IDS, tumour response by positron emission tomography-computed tomography after NAC, quality of life, adverse events, success rate of optimal cytoreduction, surgical complexity, postoperative complications and safety of IDS. We will assess these factors at screening, at every cycle of chemotherapy, at IDS, after the completion of chemotherapy, every 3 months for the first 2 years after the planned treatment and every 6 months thereafter for 3 years. DISCUSSION: We hypothesize that reducing one cycle of NAC will contribute to more resection of visible tumours despite 10% reduction of optimal cytoreduction, which could improve survival. Moreover, two cycles of NAC may increase postoperative complications by 5% compared with three cycles, which may be acceptable. TRIAL REGISTRATION: This study has been prospectively registered at ClinicalTrials.gov on Oct. 2nd, 2018 (NCT03693248, URL: https://clinicaltrials.gov/ct2/show/NCT03693248).

A randomized Comparison of laparoscopic LEns defogging using Anti-fog solution, waRm saline, and chlorhexidine solution (CLEAR).

OBJECTIVE: Current literature demonstrates a lack of comparative in vivo studies regarding laparoscopic lens fogging (LLF). This randomized trial aimed to compare 3 popular methods of minimizing or reducing LLF in laparoscopic surgery by heating the lens using warm saline, applying anti-fog solution to the lens, and rubbing the lens with chlorhexidine solution. METHODS: Ninety-six participants underwent randomization to be allocated in control (n = 24), warm saline (n = 24), anti-fog solution (n = 24), and chlorhexidine groups (n = 24). The primary outcome measure was the severity of LLF during the first 3 min after laparoscope insertion into the abdominal cavity. The severity of LLF was rated on a 10-point visual clarity scale ranging from 0 (clearest) to 10 (foggiest). The secondary outcome measures were (1) the severity of LLF during the remaining operative time other than the first 3 min, (2) the number of lens cleansings, and (3) the total time required to clean the lens. RESULTS: Lens fogging during the first 3 min and remaining operative time other than the first 3 min was significantly decreased in the warm saline group compared to that in the other 3 groups (all, P < 0.001). In post hoc analysis, the anti-fog solution group was significantly foggier than the warm saline group, but clearer than the chlorhexidine and control groups. The number of lens cleansings and total time required to clean the lens were significantly lower in the warm saline and anti-fog solution groups than in the chlorhexidine and control groups (all, P < 0.05). CONCLUSION: The use of warm saline leads to significantly fewer fogging events than the use of anti-fog solution or chlorhexidine solution, resulting in an improved continuity of surgery.

Effect of Abdominal Binder after Laparoscopic Treatment on Postoperative Recovery (BELT): A Randomized Controlled Trial.

STUDY OBJECTIVE: To determine the effect of an abdominal binder on recovery after laparoscopic surgery in patients with gynecologic disease. DESIGN: A randomized controlled trial. SETTING: A university hospital. PATIENTS: Patients scheduled for gynecologic laparoscopy were randomly assigned to the abdominal binder (n = 33) and control groups (n = 33). INTERVENTIONS: Use of an abdominal binder after laparoscopic gynecologic surgery. MEASUREMENTS AND MAIN RESULTS: Sixty-six patients scheduled for gynecologic laparoscopy between April and August 2018 were prospectively included in the abdominal binder after laparoscopic treatment (BELT) trial. The primary outcome measure was postoperative pain severity assessed using a visual analogue scale at 12, 24, and 48 hours after surgery. Secondary outcome measures included the ability to walk postoperatively, respiratory function, and degree of comfort, all assessed via the self-reported questionnaire at 48 hours after surgery. Baseline characteristics were similar in both groups. Postoperative pain scores did not significantly differ between groups. Postoperative walking and respiratory function were also statistically similar in both groups. CONCLUSION: The use of an abdominal binder in patients after gynecologic laparoscopy did not enhance recovery in terms of pain, respiratory function, or physical activity.

Searching for an ideal cervical cancer screening model to reduce false-negative errors in a country with high prevalence of cervical cancer.

The purpose of this study was to develop an ideal cervical cancer screening model to reduce false-negative errors in Korea where there is a high prevalence of cervical cancer. We conducted a cross-sectional study including 33,531 women who underwent routine cervical cancer screening in Korea. Colposcopic examinations were performed after abnormal results on their screening tests. Diagnostic capacities including sensitivity, specificity, and false-negative rate of each screening scenario were analysed at the CIN1 or worse (CIN1+) threshold with colposcopic biopsy results considered the gold standard. A total of 4117 women had valid results for Papanicolaou (Pap) cytology, human papilloma virus (HPV) tests, cervicography, and colposcopically directed biopsy were included in this study. The disease prevalence of CIN1+ was 38.1%. Pap-alone resulted in the highest false-negative rate of 46.9%, followed by HPV-alone at 25.1%, cervicography-alone at 18.7%, Pap/HPV-combined at 15.0%, Pap/cervicography-combined at 6.9% and Pap/HPV/cervicography-combined at 2.9% in a sample of 1570 women with CIN1+ lesions. Therefore, cervicography demonstrated excellent performance for the detection of CIN or cervical cancer and markedly reduced false-negative errors when used in combination with Pap cytology and HPV tests.IMPACT STATEMENTWhat is already known on this subject? False-negative rate of Pap smears is as high as approximately 40-50%. Limitations of the Papanicolaou (Pap) test have led to the development of new screening programmes for cervical cancer, such as combination screenings with human papillomavirus (HPV) tests or cervicography.What do the results of this study add? Pap-alone resulted in the highest false-negative rate of 46.9%, followed by HPV-alone at 25.1%, cervicography-alone at 18.7%, Pap/HPV-combined at 15.0%, Pap/cervicography-combined at 6.9% and Pap/HPV/cervicography-combined at 2.9% in a sample of 1570 women with CIN1+ lesions.What are the implications of these findings for clinical practice and/or further research? Cervicography demonstrated excellent performance for the detection of CIN or cervical cancer and markedly reduced false negative errors when used in combination with Pap cytology and HPV tests.

Outcomes of non-high grade serous carcinoma after neoadjuvant chemotherapy for advanced-stage ovarian cancer: a Korean gynecologic oncology group study (OV 1708).

BACKGROUND: Outcomes of patients with ovarian high-grade serous carcinoma (HGSC) treated with neoadjuvant chemotherapy (NAC) have been widely studied, but there is limited information on the outcomes of patients with non-HGSC. This study aimed to evaluate the outcomes of NAC in non-HGSC patients with advanced-stage ovarian cancer. METHODS: We conducted a retrospective cohort study of patients who underwent NAC for advanced stage non-HGSC between 2002 and 2017 in 17 institutions. Demographics, surgical outcomes, and survival rates were evaluated according to histological subtypes. RESULTS: A total of 154 patients were included in this study, comprising 20 cases (13.0%) of mucinous adenocarcinoma, 31 cases (20.1%) of endometrioid adenocarcinoma, 28 (18.2%) cases of clear cell carcinoma, 29 (18.8%) cases of low-grade serous carcinoma and 12 cases (7.8%) of carcinosarcoma. Complete remission/partial remission after the third cycle of NAC was achieved in 100 (64.9%) patients and optimal debulking surgery (residual disease ≤1 cm) at interval debulking surgery was achieved in 103 (66.9%) patients. The most common reason for performing NAC was high tumor burden (n = 106, 68.8%). The median progression-free survival (PFS) was 14.3 months and median overall survival (OS) was 52.9 months. In multivariate analyses, mucinous and clear cell carcinoma were negative prognostic factors for both PFS (p = 0.007 and p = 0.017, respectively) and OS (p = 0.002 and p = 0.013, respectively). CONCLUSIONS: In this study, poor survival outcomes were observed in patients with mucinous and clear cell carcinoma undergoing NAC. Different treatment strategies are urgently required to improve survival outcomes for this disease subset.

Temporary simultaneous two-arterial occlusion for reducing operative blood loss during laparoscopic myomectomy: a randomized controlled trial.

BACKGROUND: To evaluate the efficacy and safety of temporary simultaneous two-arterial occlusions (TESTO) in terms of operative blood loss during laparoscopic myomectomy. METHODS: A total of 62 patients with symptomatic myomas were randomly assigned to either the experimental group or the control group. In the experimental group, the uterine arteries and utero-ovarian arteries were temporarily occluded with laparoscopic bulldog clamps. The primary outcome measures were operative blood loss and change in hemoglobin. RESULTS: There were no differences in baseline demographics between the two groups. The amounts of operative blood loss (56.3 ± 42.8 mL vs. 138.2 ± 48.8 mL, p < 0.001) and change in hemoglobin (1.0 ± 0.5 g/dL vs. 1.7 ± 1.1 g/dL, p = 0.002) were significantly lower in the experimental group than that in the control group. The total operative time was not significantly different between the two groups. However, it took less time for myoma enucleation (13.1 ± 14.6 min vs. 17.6 ± 10.4 min, p = 0.006) and for uterine suturing (19.5 ± 10.7 min vs. 24.6 ± 8.8 min, p = 0.006) in the experimental group than that in the control group. None of patients in both groups developed operative complications. CONCLUSION: The use of the TESTO procedure is effective in reducing operative blood loss and hemoglobin loss without causing morbidity during laparoscopic myomectomy.

Comparison of impacts of intraperitoneal saline instillation with and without pulmonary recruitment maneuver on post-laparoscopic shoulder pain prevention: a randomized controlled trial.

BACKGROUND: Intraperitoneal isotonic saline instillation (SI) and pulmonary recruitment maneuver (RM) were indicated to alleviate post-laparoscopic shoulder pain (PLSP) effectively. The aim of this study was to compare the effects of the single strategy using SI alone and the combined strategy using SI and RM on PLSP reduction. METHODS: Subjects undergoing elective gynecologic laparoscopy were randomly allocated to a control group (no intervention, n = 48) and two intervention groups (single strategy of SI alone, n = 48; combined strategy of SI and RM, n = 48). In the control group, carbon dioxide was removed only via passive evacuation through the port sites at the completion of the laparoscopic procedure. In the saline instillation group, 20-mL/kg of body weight SI was performed. In the combined strategy group, RM using five pulmonary inflations was performed, in addition to SI. The PLSP scores, which were the primary outcome, were recorded using a visual analog scale postoperatively. RESULTS: The PLSP scores 24 and 48 h after surgery were significantly lower in the two intervention groups than in the control group (P = 0.014 and P = 0.001, respectively), while no significant differences were observed between the two intervention groups. CONCLUSIONS: The single strategy using SI alone is as effective as the combined strategy of SI and RM for removing residual carbon dioxide and consequently preventing PLSP. Therefore, considering the potential risks of pulmonary or hemodynamic complications associated with RM, the single strategy using SI alone might be a better choice than the combined strategy.

"Freshman effect" in gynecologic surgery at a teaching hospital.

PURPOSE: The purpose of this study was to determine the existence of the freshman effect in patients who underwent gynecologic surgery at a teaching hospital by comparing surgical outcomes and morbidity rates between the first academic quarter and other quarters. METHODS: All data were collected prospectively. Between January 2015 and March 2018, patients who underwent gynecologic surgeries during the first academic quarter (March, April, and May in Korea) were retrospectively compared with patients who underwent gynecologic surgeries during other academic quarters (June through February). The primary outcome measure was the incidence of operative complication. Secondary outcomes were the operative time, operative blood loss, and length of hospital stay. RESULTS: Among 1241 patients who underwent gynecologic surgery during the study period of 39 months, 1136 patients were analyzed for this study and divided into groups according to the first academic quarter (n = 335) and other academic quarters (n = 801). The baseline characteristics were not different between the groups. No significant difference in operative complications was found between the first and other academic quarters (1.5% versus 3.0%; P = 0.143). Moreover, there was no significant difference in operative time, operative blood loss, and length of hospital stay between the groups. CONCLUSIONS: This study did not demonstrate the existence of a "freshman effect", i.e., an increase in morbidity, at a Korean teaching hospital providing gynecologic surgical care. Patients undergoing gynecologic surgery can be reassured of their safety during the first academic quarter.

Ultrasonic versus monopolar energy-based surgical devices in terms of surgical smoke and lateral thermal damage (ULMOST): a randomized controlled trial.

BACKGROUND: The purpose of this study was to compare the degree of surgical smoke or vapor and lateral thermal damage caused by two different energy-based surgical devices (ESDs) used in colpotomy during total laparoscopic hysterectomy. METHODS: Patients undergoing laparoscopic hysterectomy were randomly assigned to an ultrasonic ESD group (n = 20) or monopolar ESD group (n = 20). Colpotomy was performed using the assigned ESD. The degree of surgical smoke or vapor obstructing the laparoscopic view was assessed by two independent reviewers using a 5-point Likert scale, in which a higher score indicates worse visibility. The degree of the lateral thermal damage was measured as the width from the point of instrument application to the margins of the unchanged nearby tissue using a light microscope. RESULTS: The baseline characteristics did not statistically differ between the two groups. The degree of surgical smoke or vapor obstructing vision was 1.2 ± 0.8 points in the ultrasonic group and 3.9 ± 0.7 points in the monopolar groups (p < 0.001). The lateral thermal damage was significantly increased in the monopolar group compared to in the ultrasound group (1500 µm [1200-2500 µm] vs. 950 µm [650-1725 µm], p = 0.037). CONCLUSION: Ultrasonic ESD had better laparoscopic visibility and caused less lateral thermal damage during colpotomy compared to monopolar device.

Incidence, natural course, and characteristics of postlaparoscopic shoulder pain.

BACKGROUND: To determine the incidence, natural course, and specific characteristics of postlaparoscopic shoulder pain (PLSP). METHODS: The prospective study included 105 patients undergoing laparoscopy for benign gynecologic diseases. The intensity of pain, and the identification of the pain site, was assessed 24- and 48-h after surgery, using a visual analogue scale. The description and intensity of PLSP, its aggravating and relieving factors, and the response to analgesics were assessed over a 1-week period using a self-reported questionnaire. RESULTS: Of 105 patients, 84 (80%) experienced PLSP. PLSP along with wound pain peaked one day after surgery, gradually subsided, and were not reported by the seventh day after surgery. Of the 84 patients experiencing PLSP, 77 (91.7%) had aggravating and relieving factors, which included position change (48.8%) and rest (42.9%), respectively. Analgesics provided significantly less pain relief for PLSP (32.7 ± 32.2%), when compared to relief of wound pain (68.0 ± 16.2%) (P < 0.001). CONCLUSION: PLSP, identified in 80% of our patients, resolved in most patients within the first week after laparoscopy. Since PLSP is less responsive to analgesics, when compared to wound pain, surgeons should pay attention to the prevention of PLSP among patients undergoing laparoscopy.

Temporary Simultaneous 2 Arterial Occlusions during Laparoscopic Management for Cornual Ectopic Pregnancy.

STUDY OBJECTIVE: To demonstrate a new technique of temporary simultaneous 2 arterial occlusions (TESTOs) of the uterine and ovarian (or utero-ovarian) artery to reduce operative blood loss during laparoscopic cornual resection for cornual ectopic pregnancy. DESIGN: A step-by-step explanation of the surgical procedure using video (Canadian Task Force classification III). This study was approved by the institutional review board. SETTING: A university hospital. PATIENTS: A 41-year-old woman presented with pelvic pain with 7 weeks of amenorrhea. A transvaginal sonogram and laboratory tests revealed left cornual pregnancy. She had a history of left salpingectomy caused by tubal pregnancy and wanted prompt surgical management without a surgical scar. INTERVENTIONS: During the single-port laparoscopy, we found a 3-cm unruptured ectopic mass in the left uterine cornua. The retroperitoneum was opened using a harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH) along the infundibulopelvic ligament. Then, both uterine arteries were temporarily occluded with a bulldog clamp (Aesculap, Tuttlingen, Germany) at the level where they originate from the internal iliac artery. The bulldog clamp, which is a spring-loaded crossover clamp with serrated blades that effectively occlude vessels without slippage or significant crush injury, is the laparoscopic instrument for minimizing blood loss during the surgical procedure. Each ovarian arterial vasculature was also transiently occluded at the utero-ovarian or ovarian pedicle by placing a bulldog clamp. Then, a uterine incision was made in the left cornua using a harmonic scalpel, the gestational conception was expressed through the incision, and corneal resection was completed. The uterine defect was closed using a V-Loc suture (Covidien, Mansfield, MA). In the final step, all vascular clamps were removed for reperfusion. MEASUREMENTS AND MAIN RESULTS: The operative time was 45 minutes. The procedure time for TESTO and the occlusion time (defined as the time that the bilateral uterine and ovarian vessels were occluded by bulldog clamps) were 10 and 12 minutes, respectively. The estimated blood loss was 50 mL, and her postoperative hemoglobin was 11.9 g/dL from 13.0 g/dL preoperatively. No complications occurred in the postoperative course. Her menstruation resumed 2 months after surgery. CONCLUSION: Surgical management of ectopic cornual pregnancy could be performed safely and efficiently under laparoscopy with the TESTO technique.

Elevated Preoperative CA125 or CA19-9 in Borderline Ovarian Tumors: Could It Be Suggestive of Advanced Stage or a Poor Prognosis?

OBJECTIVES: To investigate whether elevated levels of CA125 (≥35 U/mL) and CA19-9 (≥37 U/mL) suggest advanced-stage disease (defined as stage II or higher) or poor prognosis in patients with borderline ovarian tumors (BOTs). STUDY DESIGN: We retrospectively identified 591 patients with BOTs. Multivariate logistic regressions and Cox proportional hazard regressions were used to determine the clinicopathologic factors associated with the presence of advanced-stage disease and the prognostic factors associated with recurrence-free survival. RESULTS: CA125 was elevated more often in serous than in mucinous tumors (50.6 vs. 35.5%; p = 0.003), whereas CA19-9 was elevated more often in mucinous than serous tumors (33.6 vs. 15.3%; p = 0.001). An elevated CA125 level was independently associated with the presence of advanced-stage disease in serous (p = 0.005) and in mucinous BOTs (p = 0.015). However, preoperative elevation of CA19-9, unlike CA125, was not associated with the advanced-stage disease. Elevated preoperative CA125 level (p = 0.037) was an independent prognostic factor for recurrence-free survival in patients with serous BOTs. However, neither CA125 nor CA19-9 had prognostic significance in mucinous BOTs. CONCLUSIONS: Elevated preoperative CA125, unlike CA19-9, is a diagnostic and prognostic biomarker associated with the presence of advanced-stage disease and risk of relapse in patients with serous BOTs.

Randomised comparison of silicone gel and onion extract gel for post-surgical scars.

To compare the efficacy of silicone gel and onion extract gel on new surgical wounds, we performed a randomised controlled trial evaluating the appearance of the laparoscopic surgical scars of 60 subjects after 12 weeks of two times daily application of either silicone gel or onion extract gel. Objective scar assessment by the Vancouver Scar Scale (VSS) and the Image Panel Scale (IPS) and subjective scar assessment by the Body Image Scale (BIS) and Cosmetic Scale (CS) were performed after 12 weeks of treatment. Safety was also evaluated by gathering adverse events related to application of the gel. After 12 weeks of applying the assigned gel, there were no differences between the two groups in VSS (p = .779), IPS (p = .621), BIS (p = .924), or CS (p = .843). Subject compliance and safety with the assigned gel was similar between the two study groups. Our conclusion was that silicone gel and onion extract gel had similar compliance, side effects and efficacy in making surgical scars less distinct. Impact Statement What is already known on this subject: There are commercially available, topical scar emollients for prevention of surgical scarring. Despite their popularity, data demonstrating the efficacy of these scar emollients are lacking. What do the results of this study add: After 12 weeks of applying the assigned topical scar emollients, there were no differences between the two groups in terms of cosmesis and satisfaction. What are the implications of these findings for clinical practice and/or further research: Silicone gel and onion extract gel had similar compliance, side effects and efficacy in making surgical scars less distinct.