Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO).

Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.

What Is a Good Teaching Video? Results of an Online International Survey.

STUDY OBJECTIVE: To analyze surgeon views on criteria for a good teaching video with the aim of determining guidelines. DESIGN: An online international survey using a self-developed questionnaire. SETTING: A French university tertiary care hospital. PATIENTS: Three hundred eighty-eight participants answered an online questionnaire (154 women [40.53%] and 226 men [59.47%]). INTERVENTIONS: A questionnaire on the criteria for a good quality teaching surgery video was developed by our team and communicated via an online link. MEASUREMENTS AND MAIN RESULTS: The responses of 388 respondents were analyzed and highlighted the pedagogical benefits of teaching videos. The video duration may vary according to the type of media or surgical procedure but should not exceed 10 to 15 minutes for complex procedures. Providing information on the surgical setup (body mass index of the patient, Trendelenburg position degree, pressure of pneumoperitoneum, etc.) is essential. Surgical videos should be reviewed and divided into clearly defined steps with continued access to the entire nonmodified video for reviewers and be accessible on both educational and open platforms. Patient consent and relevant information should be made available. Reviews should include "bad procedure" videos, which are highly appreciated, especially by young surgeons. CONCLUSION: The many advantages of the video format, including availability and rising popularity, provide an opportunity to reinforce and complement current surgical teaching. To optimize use of this surgical teaching tool, standardization, updating, and ease of access of surgical videos should be promoted.

Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments.

INTRODUCTION: Premature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature. METHODS AND ANALYSIS: We are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required. ETHICS AND DISSEMINATION: Written informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team. TRIAL REGISTRATION NUMBER: NCT03310333.

Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

Laparoscopic surgery technology continues to advance. However, much less attention has been focused on how alteration of the laparoscopic surgical environment might improve clinical outcomes. We conducted a randomized, 2 × 2 factorial trial to evaluate whether low intraperitoneal pressure (IPP) (8 mmHg) and/or warmed, humidified CO2 (WH) gas are better for minimizing the adverse impact of a CO2 pneumoperitoneum on the peritoneal environment during laparoscopic surgery and for improving clinical outcomes compared to the standard IPP (12 mmHg) and/or cool and dry CO2 (CD) gas. Herein we show that low IPP and WH gas may decrease inflammation in the laparoscopic surgical environment, resulting in better clinical outcomes. Low IPP and/or WH gas significantly lowered expression of inflammation-related genes in peritoneal tissues compared to the standard IPP and/or CD gas. The odds ratios of a visual analogue scale (VAS) pain score >30 in the ward was 0.18 (95% CI: 0.06, 0.52) at 12 hours and 0.06 (95% CI: 0.01, 0.26) at 24 hours in the low IPP group versus the standard IPP group, and 0.16 (95% CI: 0.05, 0.49) at 0 hours and 0.29 (95% CI: 0.10, 0.79) at 12 hours in the WH gas group versus the CD gas group.

Analysis of risk factors for the removal of normal ovarian tissue during laparoscopic cystectomy for ovarian endometriosis.

BACKGROUND: The aim of this study was to identify risk factors for the removal of normal ovarian tissue during laparoscopic cystectomy for endometriosis. METHODS: A total of 121 patients who had histologically confirmed ovarian endometriosis and 56 control patients who had other histologically confirmed benign cysts were included for the present analysis. The blocks of removed tissue were sectioned at 120 microm intervals and a total of five sections were analyzed for each ovarian cyst. Eight variables (age, pre-operative medical treatment, previous surgery for ovarian endometriosis, single or multiple cysts, size of the largest cyst, side of cyst, co-existence of deep endometriosis, revised American Society for Reproductive Medicine classification) were evaluated using a generalized linear modeling analysis to identify major factors associated with the removal of normal ovarian tissue. RESULTS: Normal ovarian tissue adjacent to the cyst wall was detected in 71 patients (58.7%) with endometriosis, whereas normal ovarian tissue was removed from only three patients (5.4%) with other benign cysts. A significant factor that was independently associated with the removal of normal ovarian tissue with ovarian endometriosis was pre-operative medical treatment. CONCLUSIONS: The present retrospective, controlled study suggests that pre-operative medical treatment might be a risk factor for the removal of normal ovarian tissue during laparoscopic cystectomy for ovarian endometriosis.

Excision of the posterior vaginal fornix is necessary to ensure complete resection of rectovaginal endometriotic nodules of more than 2 cm in size.

The minimum distance between the vaginal mucosal epithelium and the endometriotic glands was <1,000 microm in 30 patients (49.2%), <2,000 microm in 44 patients (72.1%), and <5,000 microm in 60 patients (98.4%). Our findings provided histologic evidence that excision of the posterior vaginal fornix was necessary to completely remove large rectovaginal endometriotic nodules.

Laparoscopic management of adnexal masses: a gold standard?

PURPOSE OF REVIEW: To review recent literature on the laparoscopic management of adnexal masses, when this approach may be considered as a gold standard. RECENT FINDINGS: Cyst rupture was recently demonstrated to be a significant prognostic factor in stage I invasive epithelial carcinoma, and it was recommended to restrict the laparoscopic approach to patients with preoperative evidence that the cyst was benign. The laparoscopic approach is still highly controversial in masses suspicious at ultrasound. The limits of the laparoscopic approach are discussed reviewing recent literature and our experience. The laparoscopic management of adnexal masses appears to be safe in most hospitals even in developing countries. This approach is being used with increasing frequency in unusual indications such as newborns, children, adolescents and pregnant women. The learning curve for endoscopic surgery appears to be longer than expected. Many patients with benign adnexal masses, such as ovarian endometrioma, are still treated by laparotomy or with an inadequate endoscopic technique. Several studies have suggested that the stripping technique is a tissue-sparing procedure. SUMMARY: The laparoscopic puncture of malignant ovarian tumours confined to the ovaries is uncommon, and should be avoided whenever possible. The teaching of endoscopy is essential to promote adequate procedures performed according to the principles of microsurgery and to preserve postoperative ovarian physiology.