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Scientific Reports Mar 2023Tissue containment systems (TCS) are medical devices that may be used during morcellation procedures during minimally invasive laparoscopic surgery. TCS are not new...
Tissue containment systems (TCS) are medical devices that may be used during morcellation procedures during minimally invasive laparoscopic surgery. TCS are not new devices but their use as a potential mitigation for the spread of occult malignancy during laparoscopic power morcellation of fibroids and/or the uterus has been the subject of interest following reports of upstaging of previously undetected sarcoma in women who underwent a laparoscopic hysterectomy. Development of standardized test methods and acceptance criteria to evaluate the safety and performance of these devices will speed development, allowing for more devices to benefit patients. As a part of this study, a series of preclinical experimental bench test methods were developed to evaluate the mechanical and leakage performance of TCS that may be used in power morcellation procedures. Experimental tests were developed to evaluate mechanical integrity, e.g., tensile, burst, puncture, and penetration strengths for the TCS, and leakage integrity, e.g., dye and microbiological leakage (both acting as surrogates for blood and cancer cells) through the TCS. In addition, to evaluate both mechanical integrity and leakage integrity as a combined methodology, partial puncture and dye leakage was conducted on the TCS to evaluate the potential for leakage due to partial damage caused by surgical tools. Samples from 7 different TCSs were subjected to preclinical bench testing to evaluate leakage and mechanical performance. The performance of the TCSs varied significantly between different brands. The leakage pressure of the TCS varied between 26 and > 1293 mmHg for the 7 TCS brands. Similarly, the tensile force to failure, burst pressure, and puncture force varied between 14 and 80 MPa, 2 and 78 psi, and 2.5 N and 47 N, respectively. The mechanical failure and leakage performance of the TCS were different for homogeneous and composite TCSs. The test methods reported in this study may facilitate the development and regulatory review of these devices, may help compare TCS performance between devices, and increase provider and patient accessibility to improved tissue containment technologies.
Topics: Humans; Female; Uterine Neoplasms; Uterine Myomectomy; Leiomyoma; Uterus; Hysterectomy; Laparoscopy
PubMed: 36991010
DOI: 10.1038/s41598-023-31847-7 -
International Journal of Surgery Case... Apr 2023Leiomyoma is the most common gynecologic tumor which may show atypical locations and degenerations. Cystic degeneration is said to be found in 4 % of all degenerations....
INTRODUCTION AND IMPORTANCE
Leiomyoma is the most common gynecologic tumor which may show atypical locations and degenerations. Cystic degeneration is said to be found in 4 % of all degenerations. Endometriosis, the presence of endometrial glands and stroma at extrauterine sites, is a common gynaecological condition seen in 10 % to 15 % of reproductive-age women usually being associated with various degrees of fertility problems.
CASE PRESENTATION
40 years old woman with P1L1A2, with secondary sub-fertility for 5 years, presented with chief complaints of dysmenorrhoea for 1 year initially around the menstrual cycle relieving with analgesics but later not limited to the menstrual cycle and pain not relieving with analgesics since 1 month. The patient underwent fertility-sparing laparoscopic removal avoiding a laparotomy and definitive hysterectomy. Manual morcellation was achieved.
CLINICAL DISCUSSION
Cystic degeneration is rare in Leiomyoma although it is the more common gynaecological tumor in women and is associated with endometriosis probably due to retrograde menstruation.
CONCLUSIONS
Laparoscopic removal of leiomyoma without laparotomy and definitive hysterectomy for a case of cystic endometriosis in a degenerated subserous myoma which to the best of our knowledge according to our search of articles on the relevant topic is the first reported case pertaining to the topic from Nepal.
PubMed: 36940541
DOI: 10.1016/j.ijscr.2023.107975 -
Frontiers in Surgery 2023Uterine leiomyoma is the most common benign tumour of the uterus in women of reproductive age. When removed surgically, a mini-invasive procedure is preferentially used...
Uterine leiomyoma is the most common benign tumour of the uterus in women of reproductive age. When removed surgically, a mini-invasive procedure is preferentially used (laparoscopic or robotic) and the extraction of the specimen can be managed by power morcellation. In this consecutive case-series, we present three cases of parasitic leiomyoma that appeared following previous surgical management of leiomyoma using the technique of laparoscopic myomectomy with uncontained power morcellation. The time frame in between the initial surgery and the diagnosis of the parasitic leiomyoma was 5.7 years. All three patients were diagnosed with endometriosis: 2 cases prior to the initial surgery and 1 case after the initial surgery. One hypothesis could be that, due to pelvic inflammation, endometriosis is a risk factor for iatrogenic parasitic leiomyoma development in case of uncontained morcellation of leiomyoma during myomectomy.
PubMed: 36936661
DOI: 10.3389/fsurg.2023.1101078 -
PloS One 2023Uterine size is one of the essential factors determining the feasibility of a minimally invasive gynecologic surgery approach. A traditional electromechanical... (Observational Study)
Observational Study
OBJECTIVE
Uterine size is one of the essential factors determining the feasibility of a minimally invasive gynecologic surgery approach. A traditional electromechanical morcellator is a well-known tool but not without flaws. We aim to assess feasibility and safety of a novel intrauterine power morcellation device for uterine size reduction to overcome these limitations during hysterectomy.
METHODS
This single-arm, observational study was conducted in a single tertiary care medical center from April 2022 to July 2022. Feasibility and safety of a novel intrauterine morcellation device for uterine size reduction was tested in ten post-hysterectomy uteri (Ex-vivo).
MEASUREMENTS AND MAIN RESULTS
Ten uteri were examined in this trial. No major complications occurred during the procedure. All ten (10) uteri were successfully reduced in size (size reduction range was between 9% to 54%). The average resection time using the Heracure Device was 4.3 minutes (range: 1min- 10min). Mean uterus weight reduction was 21%, with a mean circumference reduction of 25%. No leakage was observed from the outer surface of the uterus/serosa after the saline injection post-procedure examination.
CONCLUSION
In this novel experiment, we verified the feasibility and safety of the Heracure device for vaginal intra-uterine morcellation for uterine size reduction. This technique could enable rapid and easy removal of the uterus through the vaginal orifice.
CLINICAL TRIAL REGISTRATION
Name of the registry: ClinicalTrials.gov; Number Identifier: NCT05332132.
Topics: Female; Humans; Morcellation; Laparoscopy; Uterus; Hysterectomy; Vagina; Uterine Neoplasms
PubMed: 36930660
DOI: 10.1371/journal.pone.0282149 -
International Journal of Gynecological... May 2023The aim of this study was to analyze the clinical and reproductive outcomes of patients treated with myomectomy who were histologically diagnosed with uterine smooth...
OBJECTIVE
The aim of this study was to analyze the clinical and reproductive outcomes of patients treated with myomectomy who were histologically diagnosed with uterine smooth muscle tumor of uncertain malignant potential (STUMP).
METHODS
Patients who were diagnosed with STUMP and underwent a myomectomy at our institution between October 2003 and October 2019 were identified. Variables of interest obtained from the institution's database included patient age, relevant medical history, pre-operative appearance of the tumor on ultrasound, parameters of the surgical procedure, histopathological analysis of the tumor, post-operative clinical course, and course of follow-up, including reinterventions and fertility outcomes.
RESULTS
There were a total of 46 patients that fulfilled the criteria of STUMP. The median patient age was 36 years (range, 18-48 years) and the mean follow-up was 47.6 months (range, 7-149 months). Thirty-four patients underwent primary laparoscopic procedures. Power morcellation was used for specimen extraction in 19 cases (55.9% of laparoscopic procedures). Endobag retrieval was used in nine patients and six procedures were converted to an open approach due to the suspicious peri-operative appearance of the tumor. Five patients underwent elective laparotomy due to the size and/or number of tumors; three patients had vaginal myomectomy; two patients had the tumor removed during planned cesarean section; and two underwent hysteroscopic resection.There were 13 reinterventions (five myomectomies and eight hysterectomies) with benign histology in 11 cases and STUMP histology in two cases (4.3% of all patients). We did not observe any recurrence as leiomyosarcoma or other uterine malignancy. We did not observe any deaths related to the diagnosis. Twenty-two pregnancies were recorded among 17 women, which resulted in 18 uncomplicated deliveries (17 by cesarean section and one vaginal), two missed abortions, and two pregnancy terminations.
CONCLUSIONS
Our study found that uterus-saving procedures and fertility-preservation strategies in women with STUMP are feasible, safe, and seem to be associated with a low risk of malignant recurrence, even while maintaining the mini-invasive laparoscopic approach.
Topics: Humans; Female; Pregnancy; Infant; Child, Preschool; Cesarean Section; Smooth Muscle Tumor; Uterus; Uterine Neoplasms; Uterine Myomectomy; Laparoscopy; Fertility; Retrospective Studies
PubMed: 36898699
DOI: 10.1136/ijgc-2022-004038 -
ACG Case Reports Journal Feb 2023An 80-year-old man with a history of an orthotopic heart transplant was found to have a 25 × 40 mm centrally ulcerated mass at the hepatic flexure during evaluation of...
An 80-year-old man with a history of an orthotopic heart transplant was found to have a 25 × 40 mm centrally ulcerated mass at the hepatic flexure during evaluation of anemia. Owing to comorbidities, the patient was deemed to be a poor surgical candidate and was referred to the advanced endoscopy team to explore palliative and potentially curative options. We present a novel sequence of intervention involving full-thickness resection with subsequent morcellation clean-up to achieve complete endoscopic removal of a neoplastic lesion.
PubMed: 36891183
DOI: 10.14309/crj.0000000000001008 -
Journal of the Korean Society of... Jan 2023Uterine leiomyoma is the most common benign pelvic tumor in female and being symptomatic is an indication for surgical removal. As laparoscopic surgery has been...
Uterine leiomyoma is the most common benign pelvic tumor in female and being symptomatic is an indication for surgical removal. As laparoscopic surgery has been developed, some cases related to parasitic leiomyomas in the port site have been reported. A 40-year-old female who a history of previous laparoscopic surgery to remove uterine myoma 2 years ago visited in outpatient clinic of general surgery with palpable mass in left lower abdomen. Contrast enhanced abdomen CT and pelvis MRI were done to evaluate the mass. It was diagnosed parasitic leiomyoma in pathologic study after surgical removal and parasitic leiomyoma should be considered when patient visited presenting abdominal mass with the history of laparoscopic myomectomy.
PubMed: 36818706
DOI: 10.3348/jksr.2022.0010 -
International Braz J Urol : Official... 2023We assessed the efficacy and safety of holmium laser enucleation of the prostate (HoLEP) in patients with high comorbidity burden.
INTRODUCTION
We assessed the efficacy and safety of holmium laser enucleation of the prostate (HoLEP) in patients with high comorbidity burden.
MATERIALS AND METHODS
Data from patients treated with HoLEP at our academic referral center from March 2017 to January 2021 were prospectively collected. Patients were divided according to their CCI (Charlson Comorbidity Index). Perioperative surgical data and 3-month functional outcomes were collected.
RESULTS
Out of 305 patients included, 107 (35.1%) and 198 (64.9%) were classified as CCI ≥ 3 and < 3, respectively. The groups were comparable in terms of baseline prostate size, symptoms severity, post-void residue and Qmax. The amount of energy delivered during HoLEP (141.3 vs. 118.0 KJ, p=0.01) and lasing time (38 vs 31 minutes, p=0.01) were significantly higher in patients with CCI ≥ 3. However, median enucleation, morcellation and overall surgical time were comparable between the two groups (all p>0.05). Intraoperative complications rate (9.3% vs. 9.5%, p=0.77), median time to catheter removal and hospital stay were comparable between the two cohorts. Similarly, early (30 days) and delayed (>30 days) surgical complications rates were not significantly different between the two groups. At 3-month follow up, functional outcomes using validated questionnaires did not differ between the two groups (all p>0.05).
CONCLUSIONS
HoLEP represents a safe and effective treatment option for BPH also in patients with high comorbidity burden.
Topics: Male; Humans; Prostate; Lasers, Solid-State; Prostatic Hyperplasia; Transurethral Resection of Prostate; Treatment Outcome; Laser Therapy; Holmium; Retrospective Studies
PubMed: 36794848
DOI: 10.1590/S1677-5538.IBJU.2022.0174 -
Acta Obstetricia Et Gynecologica... Feb 2023Meta-analyses comparing hysteroscopic electromechanical morcellation with electrosurgical resection showed a shorter operating time for electromechanical morcellation,... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Meta-analyses comparing hysteroscopic electromechanical morcellation with electrosurgical resection showed a shorter operating time for electromechanical morcellation, mainly for polypectomy. The Resectr™ 9Fr is a new hysteroscopic manual morcellator, designed to simplify this procedure. We aimed to compare manual with electromechanical morcellation for hysteroscopic polypectomy.
MATERIAL AND METHODS
This two-center randomized controlled non-inferiority trial was performed from 2018 to 2021 in the Catharina Hospital and the Ghent University Hospital. The study was registered at the Dutch Trial Register (NL6922; ICTRP ID: NTR7118). One hundred and forty women with polyps (between 8 and 20 mm) scheduled for hysteroscopic removal were randomized between manual (Resectr™ 9Fr) or electromechanical (TruClear™) morcellation. The primary outcome was time (instrumentation set-up, resection, and total procedure time).
RESULTS
The non-inferiority margin for the primary outcome time was 1.3. Mean instrumentation set-up time was 10% shorter with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 0.9; 97.5% confidence interval [CI] 0.8-1.1). Mean resection time was 30% longer with the manual compared with the motor-driven system (estimated mean ratio manual/electromechanical = 1.3; 97.5% CI 0.9-1.9). Mean total procedure time was 10% longer with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 1.1; 95% CI 0.91-1.298). The estimated odds (electromechanical/manual) of better surgeon's safety, effective and comfort scores were, respectively, 4.5 (95% CI 0.9-22.1), 7.0 (95% CI 1.5-31.9), and 5.9 (95% CI 1.1-30.3) times higher with the motor-driven compared with the manual morcellator. Conversion rates and incomplete resection rates were comparable in both groups (manual vs electromechanical) (7.6% [4/66] vs 2.9% [2/68] and 6.1% [4/66] vs 3.0% [2/66], respectively). No intraoperative and postoperative complications were registered.
CONCLUSIONS
The manual morcellator was non-inferior to the electromechanical morcellator for hysteroscopic polypectomy in terms of mean instrumentation set-up time and total procedure time. Results on resection time were inconclusive. Conversion and incomplete resection rates were within the range reported in the literature. Surgeon's reported rating for both devices was high, however, in favor of the motor-driven tissue removal system.
Topics: Pregnancy; Female; Humans; Hysteroscopy; Morcellation; Postoperative Complications; Electrosurgery; Hospitals, University
PubMed: 36680382
DOI: 10.1111/aogs.14493 -
Journal of Clinical Medicine Jan 2023Background: Uterine leiomyosarcoma (LMS) is a rare entity amongst malignant gynaecological tumours and is mostly diagnosed after surgery for benign leiomyoma (LM) of the...
Background: Uterine leiomyosarcoma (LMS) is a rare entity amongst malignant gynaecological tumours and is mostly diagnosed after surgery for benign leiomyoma (LM) of the uterus. As minimal invasive surgery is widely used, the morcellation of LM and the uterus is rather common. As there is little known about the impact of the morcellation of LMS on local and distant metastases, as well as overall survival, we carried out a large-scale retrospective study. Methods: A total of 301 LMS cases from the German Clinical Competence Centre for Genital Sarcomas and Mixed Tumours were analysed. We distinguished morcellated and non-morcellated LMS from pT1 and >pT1 tumours. Fine−Gray competing risks regressions and cumulative incidence rates were computed for the time to local recurrence, distant metastases, and patient death. Results: The recurrence free interval in pT1 LMS was significantly lower in the morcellation group with a 2-year cumulative incidence rate of 49% vs. 26% in non-morcellated LMS (p = 0.001). No differences were seen in >pT1 tumours. Distant metastases were more frequently found in non-morcellated pT1 LMS compared to the morcellated cases (5-year cumulative incidence: 54% vs. 29%, p < 0.001). There was no significant difference in time to death between both groups neither in the pT1 stages nor in >pT1 disease. Subdistribution hazard ratios estimated by multivariable competing risks regressions for the morcellation of pT1 LMS were 2.11 for local recurrence (95% CI 1.41−3.16, p < 0.001) and 0.52 for distant metastases (95% CI 0.32−0.84, p = 0.008). Conclusions: Tumour morcellation is not associated with OS for pT1 tumours. The morcellation of pT1 LMS seems to prolong the time to distant metastases whereas local recurrence is more likely to occur after the morcellation of pT1 LMS.
PubMed: 36675520
DOI: 10.3390/jcm12020591