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 ).

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.

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.

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.

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.

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.

Adverse outcomes related to morcellation in Total Laparoscopic Hysterectomy.

OBJECTIVE: This study aimed to comprehensively evaluate the complications associated with morcellation in Total Laparoscopic Hysterectomy (TLH) procedures, providing evidence-based insights to enhance patient safety and surgical efficacy. DATA SOURCES: A comprehensive literature search was conducted using multiple databases, including PubMed, EMBASE, Google Scholar, and Cochrane Central Register of Controlled Trials. The inclusion criteria were Studies that focused on morcellation and morcellation-related complications were included. The risk of bias in the included studies was assessed using established evaluation scales. METHODS OF STUDY SELECTION: Thirteen studies investigating complications associated with morcellation in TLH (Total Laparoscopic Hysterectomy) were included in this review.This review covers intraoperative blood loss, length of hospital stay, loss of bag integrity, mean uterine specimen and weight, morcellation time, operation time, and TLH morcellation complications. TABULATION, INTEGRATION, AND RESULTS: The selected studies covered different approaches and aspects related to this procedure, providing valuable insights into the factors associated with complications and efficacy of the technique in various clinical settings.This review highlights the importance of evaluating and considering complications associated with morcellation in TLH. CONCLUSION: The findings of this review provide valuable insights into complications associated with morcellation in TLH. Clinicians could use this information to make informed decisions, implement safe protocols, and improve patient care. Addressing these complications will enhance the safety and efficacy of morcellation for TLH. Ethical Compliance: All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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.

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.

Risk of hysterectomy at the time of myomectomy: an underestimated surgical risk.

OBJECTIVE: To evaluate the risk of hysterectomy at the time of myomectomy and the associated 30-day postoperative morbidity. DESIGN: Cohort study. PATIENTS: Patients who underwent myomectomies identified from the American College of Surgeons' National Surgical Quality Improvement Program from 2010 to 2021. INTERVENTION: Unplanned hysterectomy at the time of a myomectomy procedure. MAIN OUTCOME MEASURES: The Current Procedural Terminology codes were used to identify myomectomies performed with or without concurrent hysterectomy. Preoperative characteristics and morbidity outcomes were obtained. The univariate analysis was performed using the chi-square and Fisher exact tests, as appropriate. Multivariate logistic regression reported risk factors for individuals who underwent hysterectomy at the time of myomectomy. P values of <.05 were considered statistically significant. RESULTS: A total of 13,213 individuals underwent myomectomy, and 399 (3.0%) had a hysterectomy performed during myomectomy. Concurrent hysterectomy was most frequently performed with the laparoscopic approach (7.1%), followed by the abdominal (3.2%) and hysteroscopic (1.9%) approaches. Age ≥43 years, obesity class II and higher, American Society of Anesthesiologists (ASA) class greater than II, tobacco use, longer operative time (>85 minutes), and laparoscopic approach were associated with a significantly increased risk of hysterectomy. When adjusting for age, body mass index, race, ASA class, case type, surgical approach, operative time, preoperative transfusion, preoperative hematocrit, and high fibroid burden, an increased odds of hysterectomy was noted for white race, longer operative time, ASA class III or higher, obesity, laparoscopic approach, and low fibroid burden. Patients who underwent concurrent hysterectomy had a longer median length of hospital stay (2 vs. 1 day), longer median operative time (161 vs. 126 minutes), increased intraoperative/postoperative blood transfusions (14.5% vs. 9.0%), and higher rates of organ/space surgical site infections (1.5% vs. 0.5%) and return to surgery (2.0% vs. 0.7%) than those who did not (P<.05). The risk of a major complication within 30 days of myomectomy increased in patients who underwent concurrent hysterectomy after adjusting for relevant confounders (adjusted odds ratio, 2.4; 95% confidence interval, 1.8-3.2). CONCLUSION: The risk of hysterectomy during a myomectomy is higher than previously reported. The patient age of ≥43 years, obesity, white race, ASA class III or higher, longer operative time, and laparoscopic approach were associated with higher odds of hysterectomy. Identification of patients with these risk factors can aid in patient counseling and surgical planning, which may help reduce the unexpectedly high rates of hysterectomy at planned myomectomy.

A randomized controlled trial of rectal versus intramuscular diclofenac for post-operative analgesia after open myomectomy.

AIM: To determine the efficacy and safety of rectal versus intramuscularly administered Diclofenac in reducing post-operative pain in the first 24 h after open-myomectomy. METHODS: A single blind, placebo controlled randomized trial consisting of 90 consenting women that had open-abdominal-myomectomy. They were randomized into two-groups (rectal-group and intramuscular-group) of 45 women (1:1 ratio). Rectal-group received 75 mg of Diclofenac suppository 12 hourly for 24 h and placebo (3 ml of intramuscular injection-water) 12hourly for 24 h while intramuscular-group received intramuscular Diclofenac 75 mg 12 hourly for 24 h and placebo (Anusol suppository) 12 hourly for 24 h. Both groups received intramuscular Pentazocine 30 mg 6 hourly for 24 h as primary analgesic after myomectomy. Pain was assessed using a Ten-Point Visual-Analogue-Scale. Participants' satisfaction of the mode of the pain relief was assessed using the Likert-scale after 24 h. The primary outcome was the pain score using the visual-analogue-scale. The secondary outcome-measures were participants' satisfaction after 24 h of administration of the drugs, the need and frequency of rescue-analgesia and maternal-side-effects. RESULT: The baseline socio-demographic characteristics were similar in both groups. There was no statistically significant difference between both groups in pain assessment at 1 h post-myomectomy (p-value > 0.05). However, the pain assessments at 6, 12, 18 and 24 h post-myomectomy were statistically significant with more pain in intramuscular-group when compared to rectal-group. Majority of participants in rectal-group were both very satisfied (35.6 %) and satisfied (55.6 %) when compared to intramuscular-group (11.1 %) and (31,1%) respectively (p-value < 0.05). Also majority of the participants in intramuscular-group were dissatisfied (17.8 %) with none of the participant showing any form of dissatisfaction (p-value < 0.05). Majority of the participant in rectal-group had no drug side effects when compared with intramuscular-group. Epigastric discomfort was commoner in rectal-group while drowsiness was commoner in intramuscular-group. CONCLUSION: Rectal Diclofenac with intramuscular Pentazocine is significantly associated with better effectiveness in pain reduction and maternal satisfaction when compared with intramuscular Diclofenac and intramuscular Pentazocine following open-myomectomy. While epigastric discomfort was the commonest side-effect in rectal-group, drowsiness was commoner in intramuscular-group. TRIAL REGISTRATION: Pan-African-clinical-trial-registry (PACTR); PACTR202206556144219.

Age-stratified risk factors of re-intervention for uterine fibroids treated with high-intensity focused ultrasound.

OBJECTIVE: To estimate the rate and risk factors of re-intervention for patients with uterine fibroids (UFs) undergoing high-intensity focused ultrasound (HIFU) at different age distributions. METHOD: A retrospective cohort study was conducted in Nanchong Central Hospital, recruiting a total of 672 patients with UFs undergoing HIFU from June 2017 to December 2019. Using univariate and multivariate logistic regression, risk factors for re-intervention were assessed. RESULTS: Among 401 patients with UFs who completed the follow-up visits (median 47 months, range 34-61), 50 (12.46%) patients underwent re-intervention (such as high-intensity focused ultrasound, uterine artery embolization, myomectomy and hysterectomy). In the different age distributions, the re-intervention rate was 17.5% (34/194) in patients aged <45 years and 7.7% (16/207) in those aged ≥45 years. Regarding the younger patient group (aged <45 years), hypo- or iso-intensive fibroids in T2-weighted magnetic resonance imaging (T2WI) intensity may elevate the risk of re-intervention for UFs (odds ratio [OR] 2.96, 95% confidence interval [CI] 1.37-6.62; P = 0.007). Among the older patient group (aged ≥45 years), preoperative anemic patients had an increased risk of re-intervention compared with those without anemia (OR 3.30, 95% CI 1.01-10.37; P = 0.041). CONCLUSION: The re-intervention rate of HIFU decreased with increasing age. Among those aged <45 years, T2WI intensity was the independent risk factor for re-intervention, and among those aged ≥45 years, preoperative anemic status may be related to re-intervention outcome.

Comparison of Postoperative Complications Between Laparoscopic Myomectomy and Total Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To compare postoperative complications of laparoscopic myomectomy (LM) with total laparoscopic hysterectomy (TLH). A secondary outcome examined whether complications differ by age. DESIGN: A retrospective cohort study. SETTING: A multicenter academic healthcare system. PATIENTS: Individuals > 18 years old undergoing LM from 2011 to 2021 or TLH for benign indications from 2020 to 2021. INTERVENTIONS: LM or TLH. MEASUREMENTS AND MAIN RESULTS: There were 1178 patients in the LM group and 1304 in the TLH group. Patients who underwent LM were younger, more often premenopausal, nonsmokers, with lower body mass index, lower preoperative hemoglobin, larger uterine size, and lower American Society of Anesthesiologists class. LM had longer operative times (154.1 ± 74.5 vs 145.9 ± 70.5 min, p <.0001), higher use of intraoperative hemostatic agents (25% vs 9.1%, p <.0001), and higher estimated blood loss (222.7 ± 313.0 vs 87.4 ± 145.9 mL, p <.0001) than TLH. Postoperatively, LM was associated with fewer surgical site infections (3.1% vs 5.8%, p <.0001), readmissions within 30 days (2.0% vs 5.6%, p <.0001), or emergency department visits within 90 days (10.9% vs 14.4%, p = .008). LM were more likely to be admitted 24 hours postoperatively (5.9% vs 3.4%, p = .0023) or receive a blood transfusion within 30 days (4.0% vs 1.0%, p <.0001). Variables associated with increased risk of postoperative complications were tobacco use, American Society of Anesthesiologists class > 3, preoperative anemia, estimated blood loss ≥ 150 mL, and specimen weight > 250 g. Logistic regression demonstrated that operative time ≥185 minutes was most strongly associated with 24-hour admission postoperatively (odds ratio [OR] = 12.95; 95% confidence interval [CI], 3.71-45.27). In individuals ≤ 37 years of age, the LM group was less likely than the TLH group to experience surgical site infection (OR, 0.30; 95% CI, 0.14-0.62) or present to the emergency department (OR, 0.40; 95% CI, 0.26-0.63). CONCLUSION: In this large cohort of patients, both LM and TLH had low rates of postoperative complications, but the complications differed for each approach. In appropriate surgical candidates, either approach may be offered based upon patients' goals.

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).

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).

Evidence-Based Approach for Secondary Prevention of Uterine Fibroids (The ESCAPE Approach).

Uterine fibroids (UFs) are common tumors in women of reproductive age. It is imperative to comprehend UFs' associated risk factors to facilitate early detection and prevention. Simple relying on surgical/pharmacological treatment of advanced disease is not only highly expensive, but it also deprives patients of good quality of life (QOL). Unfortunately, even if the disease is discovered early, no medical intervention is traditionally initiated until the disease burden becomes high, and only then is surgical intervention performed. Furthermore, after myomectomy, the recurrence rate of UFs is extremely high with the need for additional surgeries and other interventions. This confused approach is invasive and extremely costly with an overall negative impact on women's health. Secondary prevention is the management of early disease to slow down its progression or even halt it completely. The current approach of watchful observation for early disease is considered a major missed opportunity in the literature. The aim of this article is to present an approach named the ESCAPE (Evidence-Based Approach for Secondary Prevention) of UF management. It comprises simple, inexpensive, and safe steps that can arrest the development of UFs, promote overall reproductive health, decrease the number of unnecessary surgeries, and save billions of health care systems' dollars worldwide.

Relationship between myomectomy and risk of osteoporosis or fracture: A population-based cohort study.

Myomectomy, a surgery to remove multiple leiomyomas from the uterus, is a treatment option for uterine fibroids (UF) in premenopausal patients. Osteoporosis and bone fractures are known to be strongly associated with menopausal status or hormonal changes. However, no studies have discussed the association between myomectomy and osteoporosis or fractures. This study investigated the risk of osteoporosis or fractures (vertebrae, hip, and others) in Korean patients who had undergone myomectomy without bilateral oophorectomy. We used data from the 10-year claims database of the Korean National Health Insurance from January 2009 to December 2020. Data for patients who had undergone myomectomy without oophorectomy (n = 211,969) and the control group (n = 450,124) who were randomly selected from the database were extracted. The incidence and hazard ratios (HRs) of osteoporosis or fracture between the myomectomy patients and the control group were calculated. A Cox proportional hazards model was used to analyze hazard ratios and 95% confidence intervals (CI). Subgroup analyses were performed based on age. The adjusted hazard ratios for osteoporosis and total fractures were 0.934 (95% CI: 0.916-0.954, P<0.001) and 0.919 (95% CI: 0.896-0.941, P<0.001), respectively, in the myomectomy group. The adjusted hazard ratios according to fracture site were 0.857 (95% CI: 0.799-0.92, P<0.001) for vertebral fractures, 0.706 (95% CI: 0.48-1.037, P = 0.076) for hip fractures, and 0.919 (95% CI: 0.896-0.943, P<0.001) for other fractures. In conclusion, patients who have undergone myomectomy might have a decreased risk of osteoporosis or fractures.

The Efficiency of a Uterine Isthmus Tourniquet in Minimizing Blood Loss during a Myomectomy-A Prospective Study.

Background and Objectives: The objective of this study was to assess the effectiveness of using a peri-cervical tourniquet in reducing blood loss during a laparoscopic myomectomy. Materials and Methods: This prospective study evaluated the impact of performing a concomitant tourniquet placement during a laparoscopic myomectomy (LM). A total of 60 patients were randomly allocated to one of two groups: 30 patients who underwent an LM with a tourniquet placement (the TLM group) and 30 patients who benefited from a standard LM (the SLM group). This study's main objective was to evaluate the impact of tourniquet use on perioperative blood loss, which is quantified as the difference in the pre- and postoperative hemoglobin levels (Delta Hb) and the postoperative blood transfusion rate. Results: The mean Delta Hb was statistically lower in the TLM group compared to the SLM group: 1.38 g/dL vs. 2.41 g/dL (p < 0.001). The rate of postoperative iron perfusion in the TLM group was significantly lower compared to the SLM group (4 vs. 13 patients; p = 0.02). All four patients that required a blood transfusion were from the SLM group. On average, the peri-cervical tourniquet fastening time was 10.62 min (between 7 and 15 min), with no significant impact on the overall operative time: 98.50 min for the TLM group compared to 94.66 min for the SLM group. Conclusions: Fastening a tourniquet during a laparoscopic myomectomy is a valuable technique to effectively control intraoperative bleeding and enhance surgical outcomes.