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1.

Study Objective

To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in the surgical treatment of patients with ovarian endometrioma (OE).

Design

A prospective, randomized, blinded, pilot study (Canadian Task Force classification I).

Setting

Tertiary care university hospital from December 2014 to July 2016.

Patients

Thirty women with unilateral OE undergoing laparoscopic surgery.

Intervention

Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

Measurements and Main Results

Blood samples were collected before surgery and at 2 hours, 24 hours, 1 month, and 3 months after surgery. An MP generation curve after OE surgery was created. MP generation was greater in the S group than in the L group at all time points evaluated. The MP generation curve showed a significantly higher area under the curve after excisional surgery (p <.05).

Conclusion

The higher MP levels in the S group suggest an increased inflammation and procoagulant response after this procedure.  相似文献   

2.

Study Objective

Minimally invasive surgical procedures have shown significant improvement over the last 20 years. Today, nearly half of the surgeries, including oncology, are performed with minimally invasive methods. In obstetrics and gynecology surgery practice, laparoscopy can now be used in almost all operations. In this video, we performed a laparoscopic evacuation of a 12-week missed abortion case like a cesarean section at the time of bilateral salpingectomy.

Design

A case report (Canadian Task Force classification III).

Setting

A tertiary referral center in Bursa, Turkey.

Patient

A 38-year-old patient.

Intervention

Laparoscopic evacuation of the pregnancy product (like a cesarean section) and bilateral salpingectomy. The local institutional review board approved the video.

Measurements and Main Results

Gravida: 4, parity: 3. The patient was in the 12th week of her gestation when we diagnosed a missed abortion. In situs of the operation, there was a 12-week pregnancy filling the pouch of Douglas. We clipped the uterine arteries bilaterally and retracted the bladder flap to create a safe surgical incision in the low anterior segment of the uterus. We used the monopolar cautery to incise the uterus from superior to inferior similar to the low vertical classic uterine incision in the cesarean section. The abortus material was removed with the laparoscopic endobag, and bilateral salpingectomy was performed.

Conclusion

Developments in minimally invasive surgery are progressing day by day. As advances in laparoscopic and robotic surgery progress, complicated surgical procedures would be done efficiently.  相似文献   

3.

Study Objective

To evaluate the feasibility of an en-bloc salpingectomy at the time of vaginal hysterectomy for removal of Essure inserts.

Design

Prospective observational study (Canadian Task Force classification II-1).

Setting

Monocenter study at the Conception University Hospital Center, Marseille, France.

Patients

Women seeking removal of the Essure device and candidate for vaginal hysterectomy from January 1, 2017 to January 31, 2018.

Interventions

Patient underwent a total hysterectomy and bilateral salpingectomy by the vaginal route (VH-S) with en-bloc removal of each hemiuterus with the ipsilateral fallopian tube, thereby allowing for removal of the Essure inserts without fragmentation.

Measurements and Main Results

Twenty-six VH-S were performed. There was no converted case to laparoscopy or laparotomy because of issues regarding feasibility or complications. Removal of each hemiuterus with the ipsilateral tube as a single unit was feasible in all cases. There was 1 Clavien-Dindo grade 1 perioperative complication: a bladder injury that required 10days of urinary catheterization. There were 2 grade 2 postoperative complications: 1 case of metrorrhagia of a granuloma on the vaginal fundus that was treated with silver nitrate and 1 case of acute urinary retention that required urinary catheterization for 24hours.

Conclusion

Performing a VH-S with en-bloc removal of the hemiuterus with the ipsilateral tube without fragmentation orsectioning of the Essure inserts appears to be feasible. The vaginal route can hence be an approach for women who undergo hysterectomy during Essure insert surgery removal.  相似文献   

4.

Study Objective

To demonstrate a safe laparoscopic procedure for diaphragmatic infiltrative endometriosis.

Design

Video case

Setting

Teaching hospital (Canadian Task Force classification III).

Patients

One patient presenting deep and severe diaphragmatic endometriosis.

Intervention

Laparoscopic cure of diaphragmatic endometriosis.

Measurements and Main Results

Throughout this video, which was approved by the institutional board review, we demonstrate safe and complete surgical treatment of a patient suffering severe pelvic and diaphragmatic endometriosis. The patient complained of menstrual dyspnea and shoulder pain persisting despite hormonal treatment, associated with persistent dyspareunia and pelvic pain despite a previous laparoscopic surgery. Patient positioning and anesthesia were adapted to the special requirements of the surgical technique and the expected risks. The operation consisted of the exposure of the right diaphragm by mobilization of the liver, CO2 laser vaporization of left and right diaphragmatic lesions, nerve-sparing excision of infiltrating nodules, and pleural exploration. Finally, we performed an excision of pelvic endometriosis. Participation of 3 surgical teams to this procedure allowed a safe and complete laparoscopic treatment with resolution of pain symptoms at a 1- and 3-month follow-up.

Conclusion

Laparoscopic treatment allows a safe and complete treatment of diaphragmatic endometriosis.  相似文献   

5.

Study Objective

To evaluate the long-term safety and efficacy of tension-free vaginal tape (TVT).

Design

Prospective observational study (Canadian Task Force classification II-2).

Setting

Tertiary referral center in China.

Patients

Between January 2004 and December 2005, 85 consecutive patients who underwent the TVT procedure were included. Patients with mixed incontinence or pelvic organ prolapse requiring surgery were excluded.

Interventions

TVT procedure.

Measurements and Main Results

The primary outcomes were long-term postoperative complications. The secondary outcomes included long-term subjective satisfaction (Patient Global Impression of Improvement), objective cure rate (stress test), quality of life, and sexual function. At the 13-year follow-up, 70 patients (82%) were available for evaluation. De novo overactive bladder was observed in 15.7% of patients, and voiding symptoms were found in 17.1% of patients. None of the patients reported voiding dysfunction that needed treatment with tape removal or catheterization. Tape exposure occurred in 2.9% of patients. The subjective satisfaction rate and objective cure rate were 78.6% and 81.4%, respectively.

Conclusion

TVT is a safe and effective treatment for stress urinary incontinence, even at the 13-year follow-up. The prevalence rates of overactive bladder and voiding symptoms are increased with advancing age and should not be considered long-term postoperative complications.  相似文献   

6.

Study Objective

To prospectively evaluate the mesh exposure rate after robot-assisted laparoscopic pelvic floor surgery for the treatment of female pelvic organ prolapse (POP) in a large cohort.

Design

Prospective observational cohort study (Canadian Task Force classification II-2).

Setting

Two large teaching hospitals with a tertiary referral function for pelvic floor disorders.

Patients

Patients with symptomatic POP and simplified POP quantification (S-POP) stage ≥2. Patients with a history of mesh repair or concomitant insertion of a tension-free vaginal tape were excluded.

Interventions

Robot-assisted laparoscopic sacrocolpopexy or robot-assisted laparoscopic supracervical hysterectomy with a sacrocervicopexy.

Measurements and Main Results

A blinded vaginal examination with the aid of a transparent speculum was performed to look for mesh-related complications. Mesh exposures were described following the International Urogynecological Association/International Continence Society classification system. One hundred and ninety-two patients were included, of whom 166 (86.5%) were seen for follow-up examination. The median duration of follow-up was 15.7 months (range, 8.2–44.4 months). Two vaginal mesh exposures (1.2%) were detected, both of which were treated in the outpatient clinic. One patient without any complaints had a suture exposure, which was removed in the outpatient clinic.

Conclusion

The safety of the use of mesh in pelvic floor surgery is a matter of debate owing to the occurrence of mesh-related complications. Based on the current literature, mesh-related complications seem to be lower in transabdominal mesh surgery than in transvaginal mesh surgery. In this study, a low mesh exposure rate was observed in robot-assisted abdominal pelvic floor surgery for POP.  相似文献   

7.

Study Objective

To investigate ethnic differences for moderate-to-severe endometriosis.

Design

Analysis of a prospective registry (Canadian Task Force classification II-2).

Setting

Tertiary referral center.

Patients

A total of 1594 women with pelvic pain and/or endometriosis.

Interventions

None

Measurements and Main Results

On logistic regression, adjusting for potential confounders, East/South East Asians were 8.3 times more likely than whites to have a previous diagnosis of stage III/IV endometriosis before referral (adjusted odds ratio [aOR], 8.33; 95% confidence interval [CI], 3.74–18.57), 2.7 times more likely to have a palpable nodule (aOR, 2.66; 95% CI, 1.57–4.52), 4.1 times more likely to have an endometrioma on ultrasound (aOR, 4.10; 95% CI, 2.68–6.26), and 10.9 times more likely to have stage III/IV endometriosis at the time of surgery at our center (aOR, 10.87; 95% CI, 4.34–27.21).

Conclusion

Moderate-to-severe endometriosis was more common in women with East or South East Asian ethnicity in our tertiary referral center.  This could be explained by East/South East Asians with minimal to mild disease being less likely to seek care or genetic/environmental differences that increase the risk of more severe disease among East/South East Asians. (ClinicalTrials.gov, NCT02911090.)  相似文献   

8.

Study Objective

To compare fetal, maternal, and operative outcomes of laparoscopic surgery versus laparotomy for major benign diseases including appendicitis, cholecystitis, adnexal masses, and uterine myoma during pregnancy.

Design

Retrospective cohort study (Canadian Task Force classification II-2).

Setting

The Diagnosis Procedure Combination database, a national inpatient database for acute care inpatients in Japan.

Patients

Eligible patients (n?=?6018) underwent abdominal surgery (4047 laparotomy and 1971 laparoscopy patients) from July 2010 through March 2016.

Interventions

The 2 groups were compared using propensity score matching analysis.

Measurements and Main Results

The primary outcome was fetal adverse events, including abortion or stillbirth within 7 days after surgery and premature delivery during hospitalization. Secondary outcomes were operative time, blood transfusion, and length of hospital stay after surgery. Propensity score matching created 740 pairs. Significant difference was observed in the primary outcome between propensity score–matched patients in the laparotomy versus laparoscopy group (1.8% vs .41%, respectively; risk difference, ?1.4%; 95% confidence interval, ?2.4 to ?.30; p?=?.01). Compared with the laparotomy group, the laparoscopy group had a significantly lower incidence of blood transfusion (2.3% vs .41%, p = .002), shorter operative time (115 vs 95 minutes, p <.001), and shorter hospital stay (9.2 vs 5.9 days, p <.001).

Conclusion

Our current study using propensity score matching suggests the advantages of laparoscopic surgery for benign diseases compared with laparotomy because laparoscopic surgery had advantages in short-term fetal adverse events, incidence of blood transfusion, operative time, and hospital stay.  相似文献   

9.

Study Objective

To compare the number of days required to return to daily activities after laparoscopic hysterectomy with 2 tissue extraction methods: manual morcellation via colpotomy or minilaparotomy. Secondary outcomes were additional measures of patient recovery, perioperative outcomes, containment bag integrity, and tissue spillage.

Design

Multicenter prospective cohort study and follow-up survey (Canadian Task Force classification II-2).

Setting

Two tertiary care academic centers in northeastern United States.

Patients

Seventy women undergoing laparoscopic hysterectomy with anticipated need for manual morcellation.

Interventions

Tissue extraction by either contained minilaparotomy or contained vaginal extraction method, along with patient-completed recovery diary.

Measurements and Main Results

Recovery diaries were returned by 85.3% of participants. There were no significant differences found in terms of average pain at 1, 2, or 3 weeks after surgery or in time to return to normal activities. Patients in both groups used narcotic pain medication for an average of 3 days. After adjusting for patient body mass index, history of prior surgery, uterine weight, and surgeon, there were no differences found for blood loss, operative time, length of stay, or incidence of any intra- or postoperative complication between groups. All patients had benign findings on final pathology. More cases in the vaginal contained extraction group were noted to have bag leakage on postprocedure testing (13 [40.6%] vs 3 [8.3%] tears in vaginal and minilaparotomy groups, respectively; p?=?.003).

Conclusion

Regarding route of tissue extraction, contained minilaparotomy and contained vaginal extraction methods are associated with similar patient outcomes and recovery characteristics.  相似文献   

10.
11.

Objective

To review the evidence and provide an opinion as to whether universal cervical length screening to prevent preterm birth should be adopted across Canada.

Outcomes

Outcomes evaluated include prevention of preterm birth.

Evidence

Literature searches using Knowledge Finder, Medline and Cochrane databases were searched for articles published up to April 2018 on cervical length screening for prevention of preterm birth.

Values

The evidence obtained was reviewed and evaluated by the Diagnostic Imaging Committee of the SOGC under the leadership of the principal authors, and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care.

Benefits, Harms, and Costs

The prevention of preterm birth in a cost-effective manner is of significant importance to the health of mothers and their families. This committee opinion will summarize the current evidence for universal cervical length screening to prevent preterm birth in Canada, determine whether it meets the Junger and Wilson criteria for screening tests, and make recommendations as to its use in Canada.

Validation

These guidelines have been reviewed and approved by the Diagnostic Imaging Committee of the SOGC and The Society of Obstetricians and Gynaecologists of Canada (SOGC).

Sponsors

The Society of Obstetricians and Gynaecologists of Canada (SOGC).  相似文献   

12.

Study Objective

To examine the potential beneficial effect of platelet-rich plasma (PRP) and fibrin sealant (TISSEEL; Baxter Healthcare Corporation, Deerfield, IL) on bowel wound healing after shaving of an experimentally induced endometriotic lesion.

Design

A single-blind, randomized study (Canadian Task Force classification I).

Setting

A certified animal research facility.

Animals

Thirty female Sprague-Dawley rats.

Interventions

Experimental colonic endometriosis was induced by transplanting endometrial tissue to all animals (first surgery). Thirty rats were then randomized to 1 of 3 groups according to treatment; PRP (group 1, n?=?10), fibrin sealant (group 2, n?=?10), or no agent (group 3, n?=?10) was applied after shaving of the endometriotic nodule (second surgery).

Measurements and Main Results

Colonic endometriosis was successfully induced in all subjects. Four days after the second surgery, the animals were euthanized, and microscopic evaluation was performed. The pathologist was blinded to the treatment method. Histopathologic analysis revealed that compared with the control group, collagen disposition was found in a significantly higher expression in both the PRP and fibrin sealant groups (p?=?.011 and p?=?.011, respectively). Distortion of the integrity of the colon layers was statistically more pronounced in the control group compared with the fibrin sealant group (p?=?.033), whereas greater new blood vessel formation was observed in the fibrin sealant group compared with the control (p?=?.023). No histologic evidence of residual or recurrent disease was detected.

Conclusion

Both PRP and fibrin sealant appear to be safe and associated with improved tissue healing during shaving for the excision of colonic endometriosis, attributed to the enhanced collagen disposition, neovascularization, and protection of the integrity of colon layers. Clinical trials are warranted to confirm the feasibility of PRP and fibrin sealant in the clinical setting.  相似文献   

13.

Study Objective

To assess the usefulness of narrowband imaging (NBI) to detect additional areas of endometriosis not identified by standard white light in patients undergoing laparoscopy for the investigation of pelvic pain.

Design

A prospective cohort trial (Canadian Task Force classification II). Evidence obtained from a well-designed cohort study.

Setting

A tertiary laparoscopic subspecialty unit in Melbourne, Australia.

Patients

Fifty-seven patients undergoing laparoscopy for the investigation of pelvic pain were recruited. Fifty-three patients were eligible for analysis.

Interventions

Patients underwent standard white-light laparoscopy of the pelvis followed by NBI survey to assess for any additional areas suspicious for endometriosis.

Measurements and Main Results

All identified areas of possible endometriosis were resected and sent for blinded histopathological analysis. The additional predictive value of NBI was 0% if the preceding white-light survey was negative and 86% if the preceding white-light survey was positive.

Conclusion

The use of NBI at laparoscopy for the investigation of pelvic pain is beneficial in finding additional areas of endometriosis if endometriosis is already suspected after white-light survey in a tertiary laparoscopic unit. Further research in nonspecialized units may show additional benefit and requires further research. NBI may also be useful as a diagnostic aid for trainees.  相似文献   

14.

Study Objective

To show the feasibility of the laparoscopic extraperitoneal approach for pelvic metastatic lymph node debulking in locally advanced cervical cancer.

Design

A surgical video article (Canadian Task Force classification III).

Setting

A university hospital.

Patient

A 52-year-old patient presented with stage IIA2 cervical adenocarcinoma according to Fédération Internationale de Gynécologie et d'Obstétrique classification. During the physical examination, a 45-mm tumor was discovered. Positron emission tomographic imaging was positive for hypermetabolic enlarged lymph nodes in the left external iliac region of 1.4-cm size and an standardized uptake value of 21 and in the right obturator region of 1.3-cm size and an standardized uptake value of 7.1; no aortic nodes were found using the imaging procedures. Before chemoradiation therapy, she underwent extraperitoneal aortic lymph node dissection for surgical staging at Vall d'Hebron University Hospital, Barcelona, Spain. Pelvic lymph node debulking was proposed to confirm positivity and, if so, to adjust the radiotherapy field and reduce lymph node radioresistance 1, 2.

Interventions

After a complete extraperitoneal aortic infrarenal lymph node dissection as described by Querleu et al [3], the presacral space is created to expose the iliac vessels. The enlarged lymph nodes are identified and dissected using blunt dissection, monopolar energy, and a vessel sealing device.

Measurements and Main Results

There were no intraoperative or postoperative complications. The anatomopathologic study confirmed positivity for adenocarcinoma metastasis in 3 pelvic nodes and 2 of 29 aortic nodes.

Conclusion

Laparoscopic debulking of enlarged pelvic lymph nodes via the extraperitoneal approach is a feasible procedure. It can be performed as an extension of extraperitoneal aortic lymphadenectomy in selected patients with locally advanced cervical cancer.  相似文献   

15.

Study Objective

To evaluate the effect of intraoperative superior hypogastric blocks on postoperative pain management.

Design

Prospective observational cohort study (Canadian Task Force classification II-2).

Setting

Kocaeli Derince Training and Research Hospital, University of Health Sciences, Department of Anesthesiology and Reanimation, Department of Gynecology and Obstetrics, Kocaeli, Turkey.

Patients

Sixty female patients who underwent elective laparoscopic hysterectomy were included in this study. Patients were divided into 2 groups: those who had intraoperative superior hypogastric plexus (SHP) block (Hypo; n?=?30) and those who did not have intraoperative SHP block (No-Hypo; n?=?30).

Interventions

Intraoperative SHP blocks were performed with the modified laparoscopic technique previously described by us.

Measurements and Main Results

Rescue analgesic time was calculated in minutes as the time interval between the last administration of analgesic in the operating room or postanesthesia care unit and the first analgesic demand in the surgical ward. Rescue analgesic times were found to be significantly higher in the Hypo group. Nonsteroidal anti-inflammatory drugs and opioid requirements in the postanesthesia care unit and in the surgical ward were significantly lower in the Hypo group. There was no difference between groups in postoperative nausea and vomiting.

Conclusions

Intraoperative SHP block is a preferable modality for postoperative analgesia in patients undergoing hysterectomy. The surgical laparoscopic modified anterior approach we describe is an uncomplicated and easily applicable method. More effective results would be seen if used together with wound site local anesthetic infiltration or abdominal wall plane blocks. (Clinical trial registration no. NCT03427840.)  相似文献   

16.

Study Objective

We sought to estimate the impact of sentinel nodes in gynecologic oncology on fellowship training and discuss potential solutions.

Design

Retrospective multi-institution cohort (Canadian Task Force classification II-2).

Setting

Three tertiary cancer referral cancer centers.

Patients

Patients with endometrial and vulvar cancer undergoing lymph node evaluation.

Interventions

Patient history and fellow case volumes were evaluated retrospectively for type of lymph node assessment.

Measurements and Main Results

Minimally invasive endometrial cancer and vulvar cancer fellow case volumes in 3 large institutions were reviewed and average annual volumes calculated for each clinical gynecologic oncology fellow. For vulvar cancer, probabilities of sentinel lymph node mapping and laterality of lesions were estimated from the literature. For endometrial cancer, estimates of lymphadenectomy rates were determined using probabilities calculated from our historic database and from review of the literature. Modeling the approaches to lymphadenectomy in endometrial cancer (full, selective, and sentinel), 100% versus 68% versus 24%, respectively, of patients would require complete pelvic lymphadenectomy and 100% versus 34% versus 12% would require para-aortic lymphadenectomy. In vulvar cancer, rates of inguinal femoral lymphadenectomy are expected to drop from 81% of unilateral groins to only 12% of groins.

Conclusions

Sentinel lymph node biopsy for endometrial and vulvar cancer will play an increasing role in practice, and coincident with this will be a dramatic decrease in pelvic, para-aortic, and inguinal femoral lymphadenectomies. The declining numbers will require new strategies to maintain competency in our specialty. New approaches to surgical training and continued medical education will be necessary to ensure adequate training for fellows and young faculty across gynecologic surgery.  相似文献   

17.

Study Objective

To describe the surgical technique and short-term outcomes for 26 cases of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) sacrocolpopexy for the treatment of pelvic organ prolapse (POP).

Design

Retrospective case series study (Canadian Task Force classification II-2).

Setting

Academic tertiary care university hospital in Guangdong, China.

Patients

Women diagnosed with stages II to IV POP between May 2017 and May 2018.

Interventions

vNOTES sacrocolpopexy.

Measurements and Main Results

A total of 26 patients were identified. vNOTES sacrocolpopexy was standardized after case 4, and 23 cases were completed successfully. Operative duration was a median of 184 minutes (interquartile range, 158.5–202.5), and mean estimated blood loss was 30.87 ± 20.8 mL. Mean pre- and postoperative POP Quantification System scores for the Aa point were, respectively, 1.4 ± 1.7 cm (range, –2 to 3) versus –1.85 ± .6 cm (p <.0001) and for the C point were 2.2 ± 1.9 cm (range, –1 to 5) versus –6.1± .7 cm (p <.0001). Mean pre- and postoperative Pelvic Floor Impact Questionnaire scores were 163.1 ± 46.2 versus 18.4 ± 29.3 (p <.0001). These suggest significant improvements in both physical prolapse and quality of life at 1 month after surgery. There were no complications of mesh exposure, pain, hematoma, infection, or new urinary incontinence.

Conclusion

vNOTES is a feasible approach for sacrocolpopexy, with promising short-term efficacy and safety data. Larger studies across multiple sites and surgeons should evaluate the long-term efficacy and safety profile of vNOTES sacrocolpopexy.  相似文献   

18.

Study Objective

To study the outcome of a novel method of laparoscopic neovaginal reconstruction using rudimentary uterine horn serosa and the pelvic peritoneum as a graft.

Design

Canadian Task Force classification II-1.

Setting

A university hospital.

Patients

A retrospective study of 14 patients from 2000 to 2014 of patients with vaginal agenesis who underwent laparoscopic neovagina reconstruction using rudimentary uterine horn serosa and the pelvic peritoneum as a graft.

Intervention

Patients with vaginal agenesis associated with müllerian agenesis who requested surgery. Tertiary referral center and laparoscopic unit. The creation of a neovagina using rudimentary uterine horn serosa and the pelvic peritoneum as a graft via a combined laparoscopic and vaginal route.

Measurements and Main Results

Data were collected retrospectively including postoperative vaginal length and width, complications, stenosis or reoperations, dyspareunia, and sexual satisfaction. There were no major complications from the surgery with no rectal perforation or bladder or ureteric injury. The postoperative mean (±SD) vaginal length was 6.0±0.7 cm and a width of 2 fingerbreadths. The mean operation time was 142.7±45.9 min. Median blood loss was 100 ml (range: 10 to 300 mL). The mean duration of the hospital stay was 6.6±1.6 days. The follow-up period ranged from 3 to 84 months with a median follow-up of 11 months.

Conclusion

Lee's method of neovaginoplasty using rudimentary uterine horn serosa and the pelvic peritoneum as a graft is a good method for neovagina creation with minimal morbidity, fast recovery, and minimal complications. This method results in good anatomic and functional outcome and can be a method that is widely used.  相似文献   

19.

Study Objective

To analyze and investigate reports associated with uterine artery embolization used for treatment of myomas using this database.

Design

A retrospective review of the Manufacturer and User Facility Device Experience (MAUDE) database for events related to uterine artery embolization (Canadian Task Force Classification III).

Setting

The MAUDE database was accessed online.

Patients

Patients with myomas undergoing uterine artery embolization.

Interventions

The MAUDE database was accessed online and searched for events related to uterine artery embolization reported between 1998 and 2018. These reports were reviewed and analyzed, reported events were categorized, and other relevant information was collected and tabulated.

Measurements and Main Results

A total of 193 reports published during the study period were identified. Pain was the most frequently reported event (68 events; 35.2%), followed by vaginal discharge (45 events; 23.3%), operational misfire (37 events; 19.2%), and fever or infectious complications (36 events; 18.7%). A surgical procedure was required in 27 events (14.0%), with hysterectomy reported in 7.8% of the events. Death following this procedure was mentioned in 5 events (2.6%).

Conclusion

The MAUDE database may be useful for clinicians using a Food and Drug Administration–approved medical device to identify the occurrence of adverse events and complications. A variety of adverse events associated with the use of uterine artery embolization were reported to the MAUDE database related to its use in the treatment of uterine myomas. We encourage physicians to review the MAUDE database when using medical devices, because this is an important tool to assess uncommon but major problems that could be associated with a medical device.  相似文献   

20.

Study Objective

To demonstrate a method of vaginal closure with the EndoGIA surgical stapler (Medtronic, Istanbul, Turkey) to prevent tumor spillage in laparoscopic radical hysterectomy.

Design

A step-by-step explanation of the procedure using a video.

Setting

Women's health teaching and research hospital.

Patient

A 40-year-old woman with clinical stage IBI cervical squamous cell carcinoma.

Interventions

Laparoscopic type C radical hysterectomy with pelvic lymph node dissection and ovarian transposition. Institutional ethical committee approval was not sought. However, the patient signed an informed consent that allows us to use her clinical data.

Measurements and Main Results

Minimally invasive surgery is increasingly being used in cervical cancer surgery. However, there is a current and significant debate regarding the safety of these methods. Colpotomy, which is the last step of laparoscopic radical hysterectomy, could be related to an increased risk for tumor spillage. Vaginal closure before colpotomy may be an option to prevent this spillage. In this method, after completion of the radical hysterectomy steps, the initial 5-mm left lower quadrant trocar was changed to a 15-mm trocar to allow for the placement of an EndoGIA with a green cartridge. The uterine manipulator was removed, and the uterus was elevated with a myoma screw. Then, the stapler was placed, and we checked that no other unintended structure was included in the jaws of the stapler before the firing. The EndoGIA surgical stapler was fired 2times to close the vagina. The stapler places 2 triple-staggered rows of titanium staples and knife blade cuts simultaneously between them. Once the vagina was divided, the stapler was released. The upper part of the vaginal cuff was excised and sent to pathology as a surgical margin, and the uterus was removed through the vagina. Finally, the vaginal cuff was closed with intracorporeal suturing.

Conclusion

Vaginal closure with the EndoGIA surgical stapler before colpotomy provides a safe and easy method to prevent tumor spillage and could improve the unfavorable results related to minimally invasive surgery in patients with cervical cancer.  相似文献   

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