scholarly journals Treatment rationale and design of a phase I single-arm open trial of a modified vaginal pipe for use in total laparoscopic hysterectomies

2019 ◽  
Author(s):  
Fumitake Ito ◽  
Tetsuya Kokabu ◽  
Hiroshi Matsushima ◽  
Akemi Koshiba ◽  
Taisuke Mori ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Uterine Fibroids ◽  
Operation Time ◽  
Laparoscopic Hysterectomy ◽  
Total Laparoscopic Hysterectomy ◽  
Conventional Model ◽  
Institutional Review ◽  
Medical Facilities ◽  
Secondary Endpoints ◽  
Written Informed Consent

Abstract Background: The Vagi-Pipe® is a useful device for performing total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. This study aimed to prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies. Methods: A total of 25 female subjects between 20 and 60 years old with uterine fibroids or adenomyosis will be included in this study. Patients with complications considered unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing total laparoscopic hysterectomy. The primary outcome will be safety, and the secondary endpoints will be operation time, bleeding volume, and presence of complications. The protocol was approved by the institutional review board of Kyoto Prefectural University of Medicine. In accordance with the Declaration of Helsinki, written informed consent will be obtained from all patients before registration. Discussion: This study seeks to confirm the safety and effectiveness of the C-Type Vagi-Pipe® for total laparoscopic hysterectomy. Once confirmed, the introduction of the C-Type Vagi-Pipe® is expected to make the total laparoscopic hysterectomy procedure easier to perform and thereby allow it to be performed in many more medical facilities. Results of the study will be disseminated via publications in peer-reviewed journals. Trial registration: Japan Registry of Clinical Trials (jRCT), jRCTs052180221. Registered 18 March 2019 - Retrospectively registered, https://jrct.niph.go.jp/search

Efficacy of ethanol ablation for treatment of benign cystic thyroid nodules: the first hospital-based study in Vietnam

MedPharmRes ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. 18-22
Author(s):  
Van Bang Nguyen ◽  
Van Vy Hau Nguyen ◽  
Binh Thang Tran ◽  
Chi Van Le
Keyword(s):  
Thyroid Nodules ◽  
Multiple Logistic Regression Analysis ◽  
Volume Reduction ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Ethanol Ablation ◽  
Institutional Review ◽  
Thyroid Cyst ◽  
Secondary Endpoints ◽  
Written Informed Consent

Background: In Vietnam, surgery or aspiration is preferred to treat thyroid cysts however each of them still have limitations. Purposes of this study were to evaluate the efficacy and safety of ethanol ablation in treating thyroid cysts and determine factors that predict the outcome of treatment. Methods: This prospective study was approved by the Ethics Committee of the Institutional Review Board of Family hospital and written informed consent for procedures was obtained. From May 2018 to March 2019, 23 patients who underwent treatment for thyroid cysts by EA were enrolled in this study and were followed up for 1 month at Family hospital. The primary endpoint was efficient after one month as the volume reduction ratio was ≥ 50%. Secondary endpoints were improvements in symptoms, cosmetic scores, and safety. Multiple logistic regression analysis was used. Results: In the finding, from May 2018 to March 2019, only 17 patients who matched inclusion criteria were included in the analyst, including 7 purely thyroid cysts, and 10 predominantly cystic nodules. Mean volume decreased significantly from 5.21 ± 3.37 ml to 2.35 ± 2.52 ml in corresponding to 52.87% of volume reduction with p < 0.05. Ethanol ablation (EA) success rate was 52.90% after 1 month. Symptoms and cosmetic scores were improved significantly. The thyroid function was constant. No adverse events occurred. Purely thyroid cyst was a predictive factor contributing to the success of EA. Conclusion: EA seems likely to be a safe and an efficient therapy for patients who had purely or predominantly cystic thyroid nodules.

scholarly journals The Learning Curve of Total Laparoscopic Hysterectomy in a Rural Hospital

2019 ◽  
pp. 1
Author(s):  
İsmail Biyik ◽  
Mustafa Albayrak ◽  
Fatih Keskin ◽  
Ayse Nur Usturali Mut
Keyword(s):  
Online Education ◽  
Learning Curve ◽  
Operation Time ◽  
Laparoscopic Hysterectomy ◽  
Total Laparoscopic Hysterectomy ◽  
Certification Programs ◽  
Transfusion Requirements ◽  
Before And After ◽  
Group 2 ◽  
Group 1

<p><strong>OBJECTIVES:</strong> Online education and certification programs which help most gynecologic surgeons to advance, improve and prove their skills. However, the benefits of such distant programs in terms of complication rate and operation time has not been evaluated so far. The aim of this study was to report the improvement of a single surgeon’s learning curve in total laparoscopic hysterectomy who had no previous mentorship/fellowship education, working in a rural district hospital before and after the completion of a distant on-line education and certification program - Gynaecological Endoscopic Surgical Education and Assessment.<br /><strong></strong></p><p><strong>STUDY DESIGN:</strong> Medical records of patients who underwent total laparoscopic hysterectomy between May 2015 and December 2018 were retrospectively reviewed and grouped based on the certification date of the surgeon, Group 1 before and Group 2 after certification. Groups were compared for variables that impact the learning curve (operation time, complications and conversion to laparotomy)<br /><strong></strong></p><p><strong>RESULTS:</strong> Of the 57 women eligible for evaluation 30 had total laparoscopic hysterectomy in Group 1 and 27 had total laparoscopic hysterectomy in Group 2. BMI, number of vaginal/cesarean births, previous abdominal/pelvic surgeries, operation indications, uterine weight, adnexectomy, and adhesiolysis rates, transfusion requirements, and the decrease in hemoglobin before and after operation were similar between the groups (p&gt;0.05). Operation time was significantly shorter in Group 2 (83 min vs.116 min, p&lt;0.0001). <br /><strong></strong></p><p><strong>CONCLUSION:</strong> Thirty total laparoscopic hysterectomy operations seem enough to reach a plateau in the learning curve for gynecologists working in rural areas with limited facilities who cannot afford lengthily and expensive fellowship/mentorship programs, after completing distant online certification programs.</p>

scholarly journals Total Laparoscopic Hysterectomy in Patients with Large Uteri: Comparison of Uterine Removal by Transvaginal and Uterine Morcellation Approaches

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Haibo Wang ◽  
Ping Li ◽  
Xiujuan Li ◽  
Licai Gao ◽  
Caihong Lu ◽  
...  
Keyword(s):  
Intraoperative Complications ◽  
Length Of Hospital Stay ◽  
Operation Time ◽  
Laparoscopic Hysterectomy ◽  
Total Laparoscopic Hysterectomy ◽  
Postoperative Outcomes ◽  
Statistical Significant Difference ◽  
Removal Time ◽  
Significant Difference ◽  
Large Uterus

The aim of this study was to compare the clinical results of total laparoscopic hysterectomy (TLH) for large uterus with uterus size of 12 gestational weeks (g.w.) or greater through transvaginal or uterine morcellation approaches. We retrospectively collected the clinical data of those undergoing total laparoscopic hysterectomies between January 2004 and June 2012. Intraoperative and postoperative outcomes were compared between patients whose large uterus was removed through transvaginal or morcellation approaches. The morcellation group has significantly shorter mean operation time and uterus removal time and smaller incidence of intraoperative complications than the transvaginal group (allP<0.05). No statistical significant difference regarding the mean blood loss, uterine weight, and length of hospital stay was noted in the morcellation and transvaginal groups (allP>0.05). In two groups, there was one patient in each group who underwent conversion to laparotomy due to huge uterus size. With regard to postoperative complications, there was no statistical significant difference regarding the frequencies of pelvic hematoma, vaginal stump infection, and lower limb venous thrombosis in two groups (allP>0.05). TLH through uterine morcellation can reduce the operation time, uterus removal time, and the intraoperative complications and provide comparable postoperative outcomes compared to that through the transvaginal approaches.

Drivers of Cost for Total Laparoscopic Hysterectomy Performed by Gynecologic Oncologists

2011 ◽  
Vol 18 (6) ◽  
pp. S3
Author(s):  
K.M. Esselen ◽  
D. Boruta ◽  
J. Schorge ◽  
A. Goodman ◽  
M. del Carmen ◽  
...  
Keyword(s):  
Laparoscopic Hysterectomy ◽  
Total Laparoscopic Hysterectomy

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

Sign in / Sign up

Export Citation Format

Share Document