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

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. 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. 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. This study has been prospectively registered at ClinicalTrials.gov on Oct. 2nd, 2018 (NCT03693248, URL: https://clinicaltrials.gov/ct2/show/NCT03693248).Shin Poong. Pharm. Co., Ltd. plays no role in the study design, data collection, data analysis, data interpretation, or writing for the current study

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

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. 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%. 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.This study was supported by Johnson & Johnson. The funder has no role in study design, writing of the manuscript and the decision to submit the report for publication

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 STATEMENT What 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

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

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 statement What 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

Optimal timing for performing hysterectomy according to different phase of menstrual cycle: Which is best?

The aim of this study was to determine whether the different phases of the menstrual cycle could affect operative bleeding in women undergoing laparoscopic hysterectomy. This was a retrospective comparative study. Based on the adjusted day of menstrual cycle, 212 women who underwent laparoscopic hysterectomy were classified into three groups: the follicular phase (n = 51), luteal phase group (n = 125), and menstruation group (n = 36). The primary outcome measure was the operative bleeding. There was no difference in the baseline characteristics of the patients belonging to the three groups. For the groups, there were no significant differences in operative bleeding (p = .469) and change in haemoglobin (p = .330), including operative time, length of hospital stay and complications. The menstrual cycle did not affect the operative bleeding and other parameters. Therefore, no phase of the menstrual cycle could be considered as an optimal timing for performing laparoscopic hysterectomy with minimal operative bleeding.Impact statement What is already known on this subject: the menstrual cycle results in periodic changes in haemostasis and blood flow in the reproductive organs. What the results of this study add: the menstrual cycle did not affect the operative bleeding and other operative parameters during laparoscopic hysterectomy. What the implications are of these findings for clinical practice and/or further research: no phase of the menstrual cycle could be considered as an optimal timing for performing laparoscopic hysterectomy with minimal operative bleeding

Operative outcomes of single-port-access laparoscopy-assisted vaginal hysterectomy compared with single-port-access total laparoscopic hysterectomy

AbstractObjectiveThis study aims to compare between operative outcomes of single-port-access laparoscopy-assisted vaginal hysterectomy (SPA-LAVH) and single-port-access total laparoscopic hysterectomy (SPA-TLH), further subdivided by vaginal cuff closure via laparoscopic suture (VCC-L) or via the vaginal route (VCC-V).Materials and methodsA custom-made port was used for single-port laparoscopy in 111 patients who underwent SPA-LAVH (n = 33), SPA-TLH with VCC-L (n = 35), and SPA-TLH with VCC-V (n = 43) during October 2009–October 2010. Records were reviewed retrospectively.ResultsA significant difference in the operating time was observed among the groups (p = 0.009). SPA-TLH with VCC-L took a significantly longer time to be performed (118.6 ± 41.8 minutes) than SPA-TLH with VCC-V (98.6 ± 21.3 minutes) or SPA-LAVH (102.0 ± 20.3 minutes). The decrease in hemoglobin level on the 1st day postsurgery was significantly smaller in case of SPA-LAVH (1.56 ± 0.97 g/dL, p = 0.005) compared with that in case of SPA-TLH with VCC-L (2.19 ± 0.95 g/dL) and SPA-TLH with VCC-V (2.24 ± 0.95 g/dL). No significant differences in other surgical outcomes were found.ConclusionSPA-TLH with laparoscopic vaginal suture required the longest operating time, and hemoglobin changes were smaller in the SPA-LAVH group than in the other groups. In patients undergoing SPA laparoscopy, we recommend the SPA-LAVH procedure

Effect of menstrual phase on the surgical treatment of ovarian cysts

This study aimed to determine whether the menstrual cycle affects operative bleeding and postoperative ovarian reserve in patients undergoing laparoscopic ovarian cystectomy. A total of 155 patients who had undergone laparoscopic ovarian cystectomy were classified into the follicular phase (n = 84) and luteal phase (n = 71) of the menstrual cycle. The primary outcome measures were operative blood loss and the rate of decline in ovarian reserve, as calculated by measuring serial serum anti-Müllerian hormone (AMH) levels preoperatively and 3 months postoperatively. No significant difference in the baseline demographics, operative blood loss (p = .984), the rate of decline in ovarian reserve (p = .945), and other surgical outcomes were observed between both the groups. These results demonstrate that the menstrual cycle had no influence on the operative blood loss and ovarian reserve during laparoscopic ovarian cystectomy. Therefore, the menstrual cycle is not an important factor to determine the optimal timing of ovarian cystectomy.Impact statement What is already known on this subject?: The menstrual cycle results in periodic changes in haemostasis and blood flow in the reproductive organs. What do the results of this study add?: These results demonstrate that the menstrual cycle had no influence on the operative blood loss and ovarian reserve during laparoscopic ovarian cystectomy. What are the implications of these findings for clinical practice and/or further research?: The menstrual cycle is not an important factor to determine the optimal timing of ovarian cystectomy