Determination of Whole Blood Loss From Minimally Invasive Myomectomy Using a Standardized Formula: A Pilot Study.

STUDY OBJECTIVE: To determine the median perioperative blood loss (PBL) during minimally invasive surgical (MIS) myomectomy. DESIGN: Prospective pilot study. SETTING: Large academic teaching hospital. PATIENTS: Thirty-one patients underwent laparoscopic or robotic myomectomy and completed a postoperative complete blood count (CBC) from November 2020 to August 2022. Patients had to have at least one fibroid greater than or equal to 3 cm on preoperative imaging. INTERVENTIONS: A CBC was collected preoperatively within 7 days of surgery. Estimated blood loss (EBL) was determined by the surgeon intraoperatively. A repeat CBC was drawn between postoperative days 2 through 4. PBL was calculated using the equation PBL = (patient weight in kg × 65 cc/kg) × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit. MEASUREMENTS AND MAIN RESULTS: Median PBL (536.3 cc [270.0, 909.3]) was greater than median EBL (200.0 cc [75.0, 500.0]). PBL ranged from a net gain of 191.5 cc to net loss of 2362.5 cc. Median size of the largest fibroid on preoperative imaging was 8.8 cm (6.6, 11.5), and median weight of fibroids removed was 321 g (115, 519). About half of patients (51.6%) had one fibroid removed, and 48.4% had 2 or more fibroids removed. Five patients were converted to laparotomy, 4 from robotic approaches. Two patients required a blood transfusion. CONCLUSION: Calculated PBL was greater than intraoperative EBL. This suggests there is continued blood loss post myometrial bed closure. Blood loss should be evaluated both during and after myomectomy, as intraoperative EBL underestimates total PBL.

Surgical Outcomes and Complications of Myomectomy: A Prospective Cohort Study.

STUDY OBJECTIVE: To investigate postoperative surgical and non-surgical complications that occur within 30 days following myomectomy procedures, whether laparoscopic or via open surgery. DESIGN: Prospective cohort study SETTING: Del Ponte Women's and Children's Hospital, Varese, Italy. PATIENTS: Women undergoing myomectomy either with laparoscopic or open surgery from July 2020 to June 2023 INTERVENTIONS: Data of consecutive patients who underwent abdominal myomectomy procedures, either via laparoscopy or open abdominal surgery were collected. The study examined patient characteristics, size and location of fibroids, surgical data, and complications. Univariate and multivariable analyses were employed to identify factors contributing to postoperative Clavien-Dindo grade ≥ II complications. MEASUREMENTS AND MAIN RESULTS: Overall 383 patients were included in the study. The univariate analysis showed intramural fibroid type (p = .0009), large fibroid size (p = .03), and extended operative times (p = .05) were associated with postoperative complications. Open surgical approach (p <.001) and uterine cavity opening (p = .02) also contributed to complications. Postoperative anemia emerged as the most prevalent complication. In the multivariable analysis, the open surgical approach emerged as the only independent factor associated with an increased risk of grade ≥ II complications (odds ratio 7.37; p <.0001). CONCLUSION: In this study we found an increased likelihood of complications in case of open myomectomy. While the presence of potential selection bias may have impacted this finding, it could provide valuable insights for clinicians and surgical teams in the strategic planning of myomectomy procedures.

Efficacy and safety of V-Loc™ barbed sutures versus conventional suture techniques in gynecological surgery: a systematic review and meta-analysis.

PURPOSE: One of the most challenging tasks in laparoscopic gynecological surgeries is suturing. Knotless barbed sutures are intended to enable faster suturing and hemostasis. We carried out a meta-analysis to compare the efficacy and safety of V-Loc™ barbed sutures (VBS) with conventional sutures (CS) in gynecological surgeries. METHODS: We systematically searched PubMed and EMBASE for studies published between 2010 and September 2021 comparing VBS to CS for OB/GYN procedures. All comparative studies were included. Primary analysis and subgroup analyses for the different surgery and suturing types were performed. Primary outcomes were operation time and suture time; secondary outcomes included post-operative complications, surgical site infections, estimated blood loss, length of stay, granulation tissue formation, and surgical difficulty. Results were calculated as weighted mean difference (WMD) or risk ratio (RR) and 95% confidence intervals (CI) with a random effects model, and a sensitivity analysis for study quality, study size, and outlier results was performed. PROSPERO registration: CRD42022363187. RESULTS: In total, 25 studies involving 4452 women undergoing hysterectomy, myomectomy, or excision of endometrioma. VBS were associated with a reduction in operation time (WMD - 17.08 min; 95% CI - 21.57, - 12.59), suture time (WMD - 5.39 min; 95% CI - 7.06, - 3.71), surgical site infection (RR 0.26; 95% CI 0.09, 0.78), estimated blood loss (WMD - 44.91 ml; 95% CI - 66.01, - 23.81), granulation tissue formation (RR 0.48; 95% CI 0.25, 0.89), and surgical difficulty (WMD - 1.98 VAS score; 95% CI - 2.83, - 1.13). No difference between VBS and CS was found regarding total postoperative complications or length of stay. Many of the outcomes showed high heterogeneity, likely due to the inclusion of different surgery types and comparators. Most results were shown to be robust in the sensitivity analysis except for the reduction in granulation tissue formation. CONCLUSION: This meta-analysis indicates that V-Loc™ barbed sutures are safe and effective in gynecological surgeries as they reduce operation time, suture time, blood loss, infections, and surgical difficulty without increasing post-operative complications or length of stay compared to conventional sutures.

Impact of trainees involvement on surgical outcomes of abdominal and laparoscopic myomectomy.

BACKGROUND: To determine the association of trainees involvement with surgical outcomes of abdominal and laparoscopic myomectomy including operative time, rate of transfusion, and complications. METHODS: A retrospective cohort study of 1145 patients who underwent an abdominal or laparoscopic myomectomy from 2008-2012 using the American College of Surgeons National Surgical Quality Improvement Program database (Canadian Task Force Classification II-2). RESULTS: Overall, 64% of myomectomies involved trainees. Trainees involvement was associated with a longer operative time for abdominal myomectomies (mean difference 20.17 minutes, 95% Confidence Interval (CI) [11.37,28.97], p < 0.01) overall and when stratified by fibroid burden. For laparoscopic myomectomy, there was no difference in operative time between trainees vs no trainees involvement (mean difference 4.64 minutes, 95% CI [-18.07,27.35], p = 0.67). There was a higher rate of transfusion with trainees involvement for abdominal myomectomies (10% vs 2%, p < 0.01; Odds Ratio (OR) 5.62, 95% CI [2.53,12.51], p < 0.01). Trainees involvement was not found to be associated with rate of transfusion for laparoscopic myomectomy (4% vs 5%, p = 0.86; OR 0.82, 95% CI [0.16,4.14], p = 0.81). For abdominal myomectomy, there was a higher rate of overall complications (15% vs 5%, p < 0.01; OR 2.96, 95% CI [1.77,4.93], p < 0.01) and minor complications (14% vs 4%, p < 0.01; OR 3.71, 95% CI [2.09,6.57], p < 0.01) with no difference in major complications (3% vs 2%, p = 0.23). For laparoscopic myomectomy, there was no difference in overall (6% vs 10% p = 0.41; OR 0.59, 95% CI [0.18,2.01], p = 0.40), major (2% vs 0%, p = 0.38), or minor (5% vs 10%, p = 0.32; OR 0.52, 95% CI [0.15,1.79], p = 0.30) complications. CONCLUSION: Trainees involvement was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy, however, did not impact surgical outcomes for laparoscopic myomectomy.

TITLE: Trainees Involvement in MyomectomyThe goal of our study was to determine the association of trainees involvement with surgical outcomes of fibroid excision surgery or myomectomy. We conducted a study of abdominal and laparoscopic myomectomies using an international surgical database. We found that trainees involvement in myomectomy was associated with increased operative time, rate of transfusion, and complications for abdominal myomectomy. However, trainees involvement did not impact surgical outcomes for laparoscopic myomectomy.

Reflections on Postpartum Hysterectomy as a Possible Complication of Cesarean Myomectomy: A Long Debate.

Uterine fibroids are common benign tumors found in fertile women. Numerous obstetrical issues, such as dystocia during labor, fetal hypotrophy, a ruptured amniotic sac, early labor, low-birth-weight newborns, etc., are associated with fibrous pregnant uteri. Cesarean myomectomy is not a common procedure because of the possibility of postpartum hysterectomy or a potentially lethal hemorrhage. For the chosen topic, we present two instances of emergency postpartum hysterectomies following cesarean myomectomy. After a cesarean myomectomy, two women experienced a perioperative hemorrhage that required a postpartum hysterectomy without a salpingo-oophorectomy. A postpartum hysterectomy was required in every instance due to the failure of additional hemostatic techniques to control the bleeding after the cesarean myomectomy. In every case, the location and number of fibroids-rather than their size-were the primary factors leading to the postpartum hysterectomy. In order to ensure that the patient is safe and that the advantages outweigh the dangers, the current trends in cesarean myomectomy include aiming to conduct the procedure either electively or when it offers an opportunity. The treatment is still up for debate because it is unknown how dangerous a second hysterectomy is for people who have had a cesarean myomectomy.

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial.

BACKGROUND: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. METHODS AND FINDINGS: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. CONCLUSIONS: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. TRIAL REGISTRATION: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).

Huge uterine abscess after myomectomy: A case report.

RATIONALE: Uterine abscess is a rare gynecologic entity and only a few cases have been reported so far. This study aimed to describe our clinical experience in this case. Initially, hematoma was diagnosed without detail previous medical record. Finally, laparotomy was performed due to refractory fever and highly possible diagnosis of uterine abscess. We successfully performed a hysterectomy and the patient had an uneventful recovery. PATIENT CONCERNS: A 44-year-old nulliparous woman underwent myomectomy in the local hospital, 45 days ago. She complained of irregular fever (up to 40 °C) without abdominal pain since the surgery. DIAGNOSES: Due to lack of her detail medical record, equivocal images and her strong intention to preserve uterus, she was misdiagnosed with hematoma and treated with antibiotic treatment. Finally, intraoperative findings revealed that the huge myometrial abscess contained a mass of pus. INTERVENTIONS: Laparotomy was performed due to refractory high-grade fever and highly possible diagnosis of uterine abscess. Total hysterectomy was performed to avoid the possibility of life-threatening sepsis. OUTCOMES: The postoperative course was uneventful and the patient was discharged 10 days after surgery. LESSONS: Complete imaging examinations are recommended prior myomectomy to facilitate the differential diagnosis of postoperative complications. In addition, several measures, such as maintaining aseptic conditions during surgery and postoperative drainage, play a critical role in preventing nosocomial infections. Rare uterine abscess is often mistaken for hematoma with fever. If the patient develops high fever after myomectomy, accompanied by a mass in the myometrium, the possibility of infection or even abscess formation should not be excluded. For women who need to preserve their fertility, the early diagnosis and timely administration of appropriate medication is crucial for preventing uterine loss.

Coma After Droperidol Administration: A Case Report.

In Switzerland, approximately 32,000 patients are hospitalized annually due to adverse drug reactions (ADRs), representing 2.3% of all hospitalizations. During the perioperative period, the administration of a variety of drugs from different classes over a relatively short period of time increases the risk of ADR. Here, we describe the case of a 32-year-old woman who was administered droperidol to treat nausea in the recovery room after a myomectomy and who subsequently became comatose. Correctable metabolic, respiratory, and cerebrovascular disorders were ruled out. Six hours after the event, she was extubated without residual effects. We discuss potential ADR for droperidol.

Surgical impact of bilateral transient occlusion of uterine and utero-ovarian arteries during laparoscopic myomectomy.

The objective of this article is to compare the amount of intraoperative blood loss during laparoscopic myomectomy when performing bilateral transient clamping of the uterine and utero-ovarian arteries versus no intervention. It´s a randomized controlled prospective study carried out in the Department of Obstetrics and Gynecology Ramón y Cajal University Hospital and HM Montepríncipe-Sanchinarro University Hospital, Madrid, Spain, in women with fibroid uterus undergoing laparoscopic myomectomy. Eighty women diagnosed with symptomatic fibroid uterus were randomly assigned to undergo laparoscopic myomectomy without additional intervention (Group A) or temporary clamping of bilateral uterine and utero-ovarian arteries prior to laparoscopic myomectomy (Group B). Estimated blood loss, operating time, length of hospital stay, and postoperative hemoglobin values were compared in both groups. The number of fibroids removed was similar in both groups (p = 0.77). Estimated blood loss was lower in the group of patients with prior occlusion of uterine arteries (p = 0.025) without increasing operating time (p = 0.17) nor length of stay (p = 0.17). No patient had either intra or postoperative complications. Only two patients (2.5%) required blood transfusion after surgery. We conclude that temporary clamping of bilateral uterine arteries prior to laparoscopic myomectomy is a safe intervention that reduces blood loss without increasing operative time.

Long-Term Risk of Reintervention After Surgical Leiomyoma Treatment in an Integrated Health Care System.

OBJECTIVE: To compare long-term risk of reintervention across four uterus-preserving surgical treatments for leiomyomas and to assess effect modification by sociodemographic factors in a prospective cohort study in an integrated health care delivery system. METHODS: We studied a cohort of 10,324 patients aged 18-50 (19.9% Asian, 21.2% Black, 21.3% Hispanic, 32.5% White, 5.2% additional races and ethnicities) who had a first uterus-preserving procedure (abdominal, laparoscopic, or vaginal myomectomy [referred to as myomectomy]; hysteroscopic myomectomy; endometrial ablation; uterine artery embolization) after leiomyoma diagnosis in the 2009-2021 electronic health records of Kaiser Permanente Northern California. We followed up patients until reintervention (second uterus-preserving procedure or hysterectomy) or censoring. We used a Kaplan-Meier estimator to calculate the cumulative incidence of reintervention and Cox regression models to estimate hazard ratios and 95% CIs comparing rates of reintervention across procedures, adjusting for age, parity, race and ethnicity, body mass index (BMI), Neighborhood Deprivation Index, and year. We also assessed effect modification by demographic characteristics. RESULTS: Median follow-up was 3.8 years (interquartile range 1.8-7.4 years). Index procedures were 18.0% (1,857) hysteroscopic myomectomies, 16.2% (1,669) uterine artery embolizations, 21.4% (2,211) endometrial ablations, and 44.4% (4,587) myomectomies. Accounting for censoring, the 7-year reintervention risk was 20.6% for myomectomy, 26.0% for uterine artery embolization, 35.5% for endometrial ablation, and 37.0% for hysteroscopic myomectomy; 63.2% of reinterventions were hysterectomies. Within each procedure type, reintervention rates did not vary by BMI, race and ethnicity, or Neighborhood Deprivation Index. However, rates of reintervention after uterine artery embolization, endometrial ablation, and hysteroscopic myomectomy decreased with age, and reintervention rates for hysteroscopic myomectomy were higher for parous than nulliparous patients. CONCLUSION: Long-term reintervention risks for uterine artery embolization, endometrial ablation, and hysteroscopic myomectomy are greater than for myomectomy, with potential variation by patient age and parity but not BMI, race and ethnicity, or Neighborhood Deprivation Index.

Transvaginal natural orifice transluminal endoscopic surgery for myomectomy: A more suitable surgical approach for enhanced recovery after surgery.

OBJECTIVE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is widely recognized for its potential benefits, including reducing post-surgical pain and leaving no discernible scarring. However, the anatomical specificity of the vNOTES approach may elevate the risk of nearby organ damage, such as the rectum and bladder. Thus, this study aims to demonstrate the safety and relative merits of vNOTES over transumbilical laparoendoscopic single-site surgery (LESS). METHODS: The Longitudinal Vaginal Natural Orifice Transluminal Endoscopic Surgery Study (LovNOTESS), which was conducted in Chengdu, China. A total of 110 patients who underwent myomectomy in vNOTES or LESS from January 2021 to December 2022. This study prospectively collected and compared perioperative and follow-up data of the two groups. RESULTS: In the vNOTES group, patients had shorter postoperative anal exhaust time, lower pain medications use rate, shorter hospital stay but higher intraoperative conversion rate, and higher postoperative fever rate. vNOTES decreased the anal exhaust time by approximately 8.7 h (95 %CI: -16.182, -1.262, p = 0.007). Moreover, vNOTES reduces pain medication use risk by 73.1 % (OR: 0.269, 95 %CI: 0.172, 0.318, p = 0.016). CONCLUSION: Relative to LESS, vNOTES can make patients mitigate postoperative discomfort, accelerate the recovery of gastrointestinal function, curtail hospitalization duration, and enable a more rapid return to daily activities in myomectomy. However, vNOTES has a higher risk of surgical conversion and adjacent organ injury. Therefore, larger scale prospective studies are needed to prove its security and promote the widespread application of vNOTES in myomectomy.

Systematic review and meta-analysis of current evidence in uterine artery embolization vs myomectomy for symptomatic uterine fibroids.

This review compares the efficacy of Uterine Artery Embolization (UAE) and Myomectomy (MYO) in managing symptomatic Uterine Fibroids (UFs) in women who do not want hysterectomy. A meta-analysis was performed on all available studies that evaluated the relative benefits and harms of MYO and UEA for the management of patients suffering from UFs. Outcomes evaluated reintervention, UFs scores for quality of life (QOL) and symptom severity, and other complications. To determine mean differences (MDs) or odds ratios (ORs) with 95% confidence intervals (CIs), a random or fixed-effects model was utilized. A meta-analysis of 13 studies (9 observational and 4 randomized controlled trials) was conducted. The results indicated that UAE had a higher reintervention rate (OR 1.84; 95% CI 1.62-2.10; P < 0.01; I2 = 39%), hysterectomy rate (OR 4.04; 95% CI 3.45-4.72; P < 0.01; I2 = 59%), and symptom-severity score (OR - 4.02; 95% CI 0.82, 7.22; P = 0.01; I2 = 0%) compared to MYO at a four-year follow-up. However, UAE was associated with a lower rate of early complications (OR 0.44; 95% CI 0.20-0.95; P = 0.04; I2 = 25%), and readmission rate (OR 1.16; 95% CI 1.01-1.33; P = 0.04; I2 = 0%) compared to MYO. Furthermore, both procedures had comparable improvement in pregnancy rates and abnormal uterine bleeding. In conclusion, UAE and MYO are effective in treating symptomatic UFs but they have different outcomes. The decision on which procedure to choose should be made based on individual preferences and the physician's expertise.

Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT0210094.

The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy in premenopausal women, diagnosed with uterine fibroids: protocol for a randomized controlled study (MyLacR study).

BACKGROUND: The oral gonadotropin-releasing hormone antagonist relugolix, which temporarily stops menstruation, is used to treat heavy menstrual bleeding, pelvic pressure, and low back pain in women with uterine fibroids. Treatment can also help women recover from low hemoglobin levels and possibly shrink the fibroids. However, evidence of preoperative use of relugolix before laparoscopic myomectomy is limited. Nevertheless, the treatment could reduce interoperative blood loss, decrease the risk of developing postoperative anemia, and shorten the operative time. Thus, we aim to test whether 12-week preoperative treatment with relugolix (40 mg orally, once daily) is similar to or not worse than leuprorelin (one injection every 4 weeks) to reduce intraoperative blood loss. METHODS: Efficacy and safety of preoperative administration of drugs will be studied in a multi-center, randomized, open-label, parallel-group, noninferiority trial enrolling premenopausal women ≥ 20 years of age, diagnosed with uterine fibroids and scheduled for laparoscopic myomectomy. Participants (n = 80) will be recruited in the clinical setting of participating institutions. The minimization method (predefined factors: presence or absence of fibroids ≥ 9 cm and the International Federation of Gynecology and Obstetrics [FIGO] type 1-5 fibroids) with randomization is used in a 1:1 allocation. Relugolix is a 40-mg oral tablet taken once a day before a meal, for 12 weeks, up to the day before surgery. Leuprorelin is a 1.88 mg, or 3.75 mg subcutaneous injection, given in three 4-week intervals during patient visits before the surgery. For the primary outcome measure of intraoperative bleeding, the blood flow is collected from the body cavity, surgical sponges, and collection bag and measured in milliliters. Secondary outcome measures are hemoglobin levels, myoma size, other surgical outcomes, and quality-of-life questionnaire responses (Kupperman Konenki Shogai Index and Uterine Fibroid Symptoms-Quality of Life). DISCUSSION: Real-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy. TRIAL REGISTRATION: jRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials ( https://jrct.niph.go.jp ).

The great debate: Surgical outcomes of laparoscopic versus laparotomic myomectomy. A meta-analysis to critically evaluate current evidence and look over the horizon.

Myomectomy is one of the most common surgical procedure in the field of gynecology. However, the role of laparoscopic myomectomy is still debated for many factors, including surgical considerations, safety and fertility concerns, long-term outcomes, and cost-related issues. The aim of this study is to evaluate the surgical peri- and post-operative outcomes of laparoscopic and abdominal myomectomy. A systematic search for studies was performed up to June 2023 through MEDLINE, Pubmed, Embase. Studies reporting the comparison of surgical and obstetrical outcomes in laparoscopic versus laparotomic myomectomy were included for the following outcomes: time of surgery, estimated blood loss, decrease of postoperative hemoglobin, hospital stay, intra-operative complication rates, postoperative complications rates, postoperative analgesic use, postoperative pain at 24 h and pregnancy rate. The meta-analysis was performed using the Cochrane Review software. Fifty-six relevant articles were retrieved through the process of evidence acquisition. Eleven articles met inclusion criteria, for a total of 2,133 patients undergoing laparoscopic or laparotomic myomectomy. The estimated blood loss [standard mean differences (SMD) 0.72, IC 95 % 0.22 to 1.22], the hospital stays [SMD 3.12, IC 95 % 0.57 to 4.28], were significantly lower in laparoscopic than in open group. No statistically significant difference in intra-operative and post-operative complication rates, in pregnancy rate and others obstetrical outcomes between two surgical approaches were found. The findings of present metanalysis suggest that laparoscopic myomectomy offers multiple benefits, including reduced blood loss, shorter hospital stays, and less postoperative analgesic need, without a significant increase in complication rates and similar results in obstetrical outcomes when compared to abdominal myomectomy. However, the presence of few randomized studies on selected population may limit the generalizability of the findings to the entire population. Therefore, more well-designed studies or large population programdata to draw definitive conclusions are therefore warranted.

Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial).

BACKGROUND/AIM: Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. PATIENTS AND METHODS: We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. RESULTS: There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. CONCLUSION: Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).

Factors associated with the complications of hysteroscopic myomectomy / Fatores associados às complicações da miomectomia por histeroscopia

Abstract Objective To evaluate the factors associated with complete myomectomy in a single surgical procedure and the aspects related to the early complications. Methods A cross-sectional study with women with submucous myomas. The dependent variables were the complete myomectomy performed in a single hysteroscopic procedure, and the presence of early complications related to the procedure. Results We identified 338 women who underwent hysteroscopic myomectomy. In 89.05% of the cases, there was a single fibroid to be treated. According to the classification of the International Federation of Gynecology and Obstetrics (Fédération Internationale de Gynécologie et d'Obstétrique, FIGO, in French),most fibroids were of grade 0 (66.96%), followed by grade 1 (20.54%), and grade 2 (12.50%). The myomectomies were complete in 63.31% of the cases, and the factors independently associated with complete myomectomy were the diameter of the largest fibroid (prevalence ratio [PR]: 0.97; 95% confidence interval [95%CI]: 0.96-0.98) and the classification 0 of the fibroid according to the FIGO (PR: 2.04; 95%CI: 1.18-3.52). We observed early complications in 13.01% of the hysteroscopic procedures (4.44% presented excessive bleeding during the procedure, 4.14%, uterine perforation, 2.66%, false route, 1.78%, fluid overload, 0.59%, exploratory laparotomy, and 0.3%, postoperative infection). The only independent factor associated with the occurrence of early complications was incomplete myomectomy (PR: 2.77; 95%CI: 1.43-5.38). Conclusions Our results show that hysteroscopic myomectomy may result in up to 13% of complications, and the chance of complete resection is greater in small and completely intracavitary fibroids; women with larger fibroids and with a high degree of myometrial penetration have a greater chance of developing complications from hysteroscopic myomectomy.

Resumo Objetivo Avaliar os fatores associados a miomectomia por histeroscopia completa em um único procedimento e as suas complicações. Métodos Estudo de corte transversal com mulheres submetidas a histeroscopia para exérese de miomas submucosos. As variáveis dependentes foram a miomectomia completa realizada em um tempo cirúrgico único, e a presença de complicações precoces relacionadas ao procedimento. Resultados Analisamos 338 mulheres que foram submetidas a miomectomia histeroscópica. Em 89,05% dos casos, o mioma a ser tratado era único. Quanto à classificação da Federação Internacional de Ginecologia e Obstetrícia (Fédération Internationale de Gynécologie et d'Obstétrique, FIGO, em francês), a maioria era de grau 0 (66,96%), seguidos pelos graus 1 (20,54%) e 2 (12,50%). As miomectomias foram completas em 63,31% das mulheres, sendo que os fatores independentemente associados à miomectomia completa foram o diâmetro do maior mioma (razão de prevalência [RP]: 0,97; intervalo de confiança de 95% [IC95%]: 0,96-0,98) e a classificação FIGO grau 0 (RP: 2,04; IC95%: 1,18-3,52). Foram observadas complicações precoces em 13,01% dos procedimentos (4,44% apresentaram sangramento excessivo durante o procedimento, 4,14%, perfuração uterina, 2,66%, falso pertuito, 1,78%, intoxicação hídrica, 0,59%, laparotomia exploradora, e 0,3%, infecção pósoperatória). O único fator independentemente associado à ocorrência de complicações precoces foi a realização de miomectomia incompleta (RP: 2,77; IC95%: 1,43-5,38). Conclusão Nossos resultados mostram que as complicações da miomectomia por histeroscopia podem ocorrer em até 13% dos procedimentos. A chance de ressecção completa é maior em miomas pequenos e completamente intracavitários; mulheres com miomas maiores e com maior grau de penetração miometrial têm maiores chances de desenvolver complicações.

Neumopericardio en el transcurso de una miomectomía laparoscópica / Neumopericardium in the course of laparoscopic myomectomy

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