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PLoS Medicine Dec 2023Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last... (Randomized Controlled Trial)
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).
Topics: Humans; Female; Middle Aged; Adolescent; Uterine Myomectomy; Uterine Neoplasms; Propofol; Quality of Life; Leiomyoma; Analgesia; Anesthesia, General; Pain
PubMed: 38153958
DOI: 10.1371/journal.pmed.1004323 -
Journal of Clinical Medicine Dec 2023The aim of this study is to investigate the prevalence of occult malignant mesenchymal tumors in patients operated on for uterine fibroids in relation to the surgical...
The aim of this study is to investigate the prevalence of occult malignant mesenchymal tumors in patients operated on for uterine fibroids in relation to the surgical approach and type of operation. A retrospective review of all patients that underwent surgery for uterine fibroids (January 2011-December 2018) at the 1st Department of Obstetrics & Gynecology at "Papageorgiou" Hospital. The surgical approach and clinicopathological characteristics were analyzed. A total of 803 patients were operated on: 603 (75.1%) with laparotomy, 187 (23.3%) laparoscopically, and 13 (1.6%) vaginally. Furthermore, 423 (52.7%) patients underwent hysterectomy and 380 (47.3%) myomectomies. Laparoscopy and myomectomy were offered to younger patients with fewer smaller uterine fibroids and were associated with statistically significant shorter hospitalization. The pathological reports revealed: 690 (86%) benign leiomyomas, 32 (4%) cellular leiomyomas, 29 (3.6%) degenerated leiomyomas, 22 (2.7%) adenomyomas, 18 (2.2%) atypical-bizarre leiomyomas, 1 (0.1%) STUMP, 5 (0.65%) endometrial stromal sarcomas, and 6 (0.75%) cases of leiomyosarcomas (LMS). All LMS were preoperatively characterized as suspicious and underwent abdominal hysterectomy. Morcellation was offered in two cases of atypical leiomyomas, with no morcellation-associated complication. Laparoscopy as a valuable surgical approach for young patients with fewer in number and smaller in size fibroids is associated with shorter hospitalization. The risk of unintended morcellation of LMS seems to be very low and can be reduced with careful preoperative work-up but not eliminated.
PubMed: 38137623
DOI: 10.3390/jcm12247555 -
Central European Journal of Urology 2023The aim of this study was to assess the effectiveness of low-power thulium (30 W) and the duration necessary to eliminate adenomas at the level of the surgical capsule,...
INTRODUCTION
The aim of this study was to assess the effectiveness of low-power thulium (30 W) and the duration necessary to eliminate adenomas at the level of the surgical capsule, as well as its impact on postoperative urinary and sexual function.
MATERIAL AND METHODS
Patients with symptomatic benign prostatic hyperplasia (BPH), who had ThuLEP between December 2019 and March 2022 and had a prostate size >80 mL and had not responded to the medication therapy, were included. The prostate size, prostate-specific antigen (PSA), enucleation and morcellation times, postoperative International Prostate Symptom Score (IPSS), and International Index of Erectile Function-5 (IEFF-5) records at 1, 3, 6, and 12 months were among the information gathered.
RESULTS
The average age of the 80 patients who received ThuLEP was 66.7 ±6.4 years, with a mean prostate volume of 112.65 ±19.3 mL. The mean duration for enucleation was 71 ±11 min. At the initial follow-up after one month, the mean IPSS was 8.012 ±1.78 mL and the mean Q enhancement was 30.16 ±4 mL s. In contrast to baseline, our findings demonstrated a substantial improvement in postoperative urgency and urgency urinary incontinence (UUI) (p = 0.005) but no meaningful variation in IIEF-5 score at the 12-month follow-up.
CONCLUSIONS
Low-power ThuLEP is worthwhile for therapeutic use because it effectively treats patients with large prostates with satisfactory urinary and sexual effects.Clinical trials .gov ID: NCT05494944.
PubMed: 38045774
DOI: 10.5173/ceju.2023.50 -
Taiwanese Journal of Obstetrics &... Nov 2023Operative hysteroscopy is a common gynecologic procedure, but it carries the risk of complications. Spontaneous small intestine perforation is rare and fatal, especially...
OBJECTIVE
Operative hysteroscopy is a common gynecologic procedure, but it carries the risk of complications. Spontaneous small intestine perforation is rare and fatal, especially in young adults. We present a spontaneous small intestine perforation after operative hysteroscopy with mimicking sign of uterine perforation after operation hysteroscopy.
CASE REPORT
A 30-year-old nulligravida woman underwent Truclear® hysteroscopic polypectomy in the morning in LMD. She suffered from upper abdominal pain in the afternoon. Subsequently, progressive abdominal distention and imminent shock occurred the next morning. Initially, it was supposed to be a case of uterine rupture with internal bleeding. She was transferred to the emergency department of our hospital. Complete biochemistry data and abdominal CT were performed. The CT revealed pneumoperitoneum and ascites. Emergent laparoscopy was arranged. The abdominal cavity was full of intestinal fluid and the myomatous uterus was intact. The surgeon performed a laparotomy, two sites of spontaneous perforation of the small intestine were detected. The patient underwent laparotomic segmental resection and anastomosis and was discharged 14 days after surgery without incident.
CONCLUSIONS
The risk of uterine perforation during hysteroscopy is up to 1.6%. The use of non-thermal intrauterine morcellator device (Truclear®) has been shown to significantly reduce the risk of perforation and thermal injury. As this case highlights, we suspected the possibility of uterine perforation immediately after hysteroscopic surgery. However, it happened to be rare spontaneous perforation of small bowel. The patient recovered well after timely transfer and management. Hysteroscopy is a very common procedure in gynecologic clinics, but even relatively safe intrauterine morcellator devices carry risk of complications. As a healthcare provider, we should beware of any comorbidity, for sometimes it would be catastrophic.
Topics: Pregnancy; Female; Humans; Adult; Hysteroscopy; Uterine Perforation; Spontaneous Perforation; Laparoscopy; Intestine, Small
PubMed: 38008515
DOI: 10.1016/j.tjog.2023.06.002 -
Revista Da Associacao Medica Brasileira... 2023The aim of this study was to analyze the surgical content of the 50 most-viewed laparoscopic myomectomy videos on YouTube while evaluating the educational quality and...
OBJECTIVE
The aim of this study was to analyze the surgical content of the 50 most-viewed laparoscopic myomectomy videos on YouTube while evaluating the educational quality and accuracy of the videos.
METHODS
In this cross-sectional study, the keyword "laparoscopic myomectomy" was searched in publicly available content on YouTube, and the videos were sorted by view count using YouTube's advanced search options. Out of the first 66 videos, only 50 were eligible according to our selection criteria. One associate professor of gynecology and one gynecology resident watched these videos independently and evaluated the quality and surgical aspects. Our primary outcome was the scores of the Quality Criteria for Consumer Health Information and Global Quality Score and the features of the surgical technique.
RESULTS
The 50 most-viewed laparoscopic myomectomy videos were uploaded between 2010 and 2021. They had a mean of 66636.6±103772.2 views. According to the Quality Criteria for Consumer Health Information criteria, 78% of the videos were categorized as "poor," 12% of them were "fair," and 10% of them were "very poor." The indication of the surgery was not specified in 27 (54%) of them. The surgeons in 39 (79.6%) of the videos did not use any containment system for the power morcellation, even though it was restricted by the United States Food and Drug Administration. The preoperative and perioperative precautions to minimize blood loss were underemphasized. There was no scientific evidence in 49 (98%) of the videos.
CONCLUSION
Laparoscopic myomectomy videos on YouTube are limited in terms of providing evidence-based and well-organized scientific knowledge.
Topics: United States; Humans; Female; Cross-Sectional Studies; Uterine Myomectomy; Educational Status; Cell Movement; Laparoscopy; Video Recording; Reproducibility of Results
PubMed: 37971128
DOI: 10.1590/1806-9282.20230736 -
Cureus Sep 2023Leiomyoma is a rare tumor that arises from mesenchymal cells, with few reported cases of treatment using holmium laser enucleation of the prostate. A 74-year-old man...
Leiomyoma is a rare tumor that arises from mesenchymal cells, with few reported cases of treatment using holmium laser enucleation of the prostate. A 74-year-old man with dysuria had a mass near the bladder neck in magnetic resonance imaging; this entity was suspected to be a leiomyoma. The patient underwent holmium laser enucleation of the prostate and one lobe was removed. However, the mass was firm and morcellation was difficult to break into small pieces. Therefore, it was fragmented via trans-urethral resection and removed with a curette. The postoperative course was favorable, with a positive clinical outcome. This case highlights the efficacy of holmium laser enucleation of the prostate in the management of prostatic leiomyoma and emphasizes its importance as a viable treatment option.
PubMed: 37846242
DOI: 10.7759/cureus.45273 -
Gynecology and Minimally Invasive... 2023
PubMed: 37807991
DOI: 10.4103/gmit.gmit_27_23 -
International Neurourology Journal Sep 2023We aimed to identify the risk factors for salvage procedure (SP) required for refractory adenomatous tissue resistant to morcellation during holmium laser enucleation of...
PURPOSE
We aimed to identify the risk factors for salvage procedure (SP) required for refractory adenomatous tissue resistant to morcellation during holmium laser enucleation of the prostate (HoLEP).
METHODS
Patients who underwent HoLEP between January 2010 and April 2020 at Seoul National University Hospital were analyzed. SPs were defined as cases of conversion to resection of the prostatic tissue using an electrosurgical loop after morcellation or secondary morcellation a few days after surgery or conversion to open cystotomy.
RESULTS
Among a total of 2,427 patients, 260 were identified as having SP (SP group) (transurethral resection-nodule [n = 250, 96.1%], secondary morcellation a few days after surgery [n = 9, 3.5%], and conversion to open cystotomy [n = 1, 0.4%]). Patients in the SP group were older and had higher 5-α reductase inhibitors use, higher prostate-specific antigen, larger total prostate volume, and larger transition zone volume (TZV) than those in the non-SP group. In the multivariable logistic regression analysis, only age and TZV were associated with SP. Compared to 40s and 50s, the odds ratios (ORs) were 3.84 in 60s (95% confidence interval [CI] 1.37-10.78, P = 0.011), 4.53 in 70s (95% CI, 1.62-12.62, P = 0.004), and 6.59 in 80s or older (95% CI, 2.23-19.46, P = 0.001). The ORs of the SP were analyzed per TZV quartile. Compared to TZV ≤ 20.3 mL, the OR was 3.75 in 32.0 mL < TZV ≤ 50.4 mL (95% CI, 2.00-7.04, P < 0.001) and 8.25 in 50.4 mL < TZV (95% CI, 4.06-16.77, P < 0.001).
CONCLUSION
The risk of refractory morcellation increased in patients aged > 60 years or those with TZV > 32 mL. In order to more efficiently remove these resistant adenomas, it is necessary to develop more efficient morcellators in the future.
PubMed: 37798887
DOI: 10.5213/inj.2346076.038 -
Archives of Gynecology and Obstetrics Jan 2024Uterine leiomyomas are benign uterine tumors. The choice of surgical treatment is guided by patient's age, desire to preserve fertility or avoid "radical" surgical...
PURPOSE
Uterine leiomyomas are benign uterine tumors. The choice of surgical treatment is guided by patient's age, desire to preserve fertility or avoid "radical" surgical interventions such as hysterectomy. In laparotomy, the issue of extracting the fibroid from the cavity does not arise. However, in laparoscopy and robotic surgery, this becomes a challenge. The aim of the present study was to determine the optimal surgical approach for fibroid extraction following laparoscopic or robotic myomectomy in terms of postoperative pain, extraction time, overall surgical time, scar size, and patient satisfaction.
METHODS
A total of 51 patients met the inclusion criteria and were considered in our analysis: 33 patients who had undergone the "ExCITE technique" (Group A), and 18 patients a minilaparotomy procedure (Group B), after either simple myomectomy, multiple myomectomy, supracervical hysterectomy, or total hysterectomy. The diagnosis of myoma was histologically confirmed in all cases.
RESULTS
Regarding the postoperative pain evaluation, at 6 h, patients reported 4 [3-4] vs 6 [5.3-7] on the VAS in Group A and B, as well as at 12 h, 2 [0-2] vs 3.5 [2.3-4] in Group A and B, respectively: both differences were statistically significant (p < 0.001). No statistically significant difference at 24 h from surgery was found. All patients in Group A were satisfied with the ExCITE technique, while in Group B only 67% of them. The length of the hospital stay was significantly shorter in Group A as compared to Group B (p = 0.007). In terms of the operative time for the extraction of the surgical specimen, overall operative time, and the scar size after the surgery, there was a statistically significant difference for those in Group A.
CONCLUSION
The ExCITE technique does not require specific training and allows the surgeon to offer a minimally invasive surgical option for patients, with also an aesthetic result. It is a safe and standardized approach that ensures tissue extraction without the need for mechanical morcellation.
Topics: Female; Humans; Laparotomy; Retrospective Studies; Cicatrix; Leiomyoma; Uterine Neoplasms; Uterine Myomectomy; Minimally Invasive Surgical Procedures; Laparoscopy; Hysterectomy; Pain, Postoperative
PubMed: 37796281
DOI: 10.1007/s00404-023-07239-7 -
Healthcare (Basel, Switzerland) Sep 2023Uterine fibromas are the most common benign uterine tumors. Although the majority of leiomyomas remain asymptomatic, they can cause serious clinical problems, including... (Review)
Review
Uterine fibromas are the most common benign uterine tumors. Although the majority of leiomyomas remain asymptomatic, they can cause serious clinical problems, including abnormal uterine bleeding, pelvic pain, and infertility, which require effective gynecological intervention. Depending on the symptoms as well as patients' preferences, various treatment options are available, such as medical therapy, non-invasive procedures, and surgical methods. Regardless of the extent of the surgery, the preferred option is the laparoscopic approach. To reduce the risk of spreading occult malignancy and myometrial cells associated with fragmentation of the specimen before its removal from the peritoneal cavity, special systems for laparoscopic contained morcellation have been developed. The aim of this review is to present the state-of-the-art contained morcellation. Different types of available retrieval bags are demonstrated. The advantages and difficulties associated with contained morcellation are described. The impact of retrieval bag usage on the course of surgery, as well as the effects of the learning curve, are discussed. The role of contained morcellation in the overall strategy to optimize patient safety is highlighted.
PubMed: 37761678
DOI: 10.3390/healthcare11182481